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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001449-11 | EudraCT Number |
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This study assessed the influence of pink vs. white pressurized metered-dose inhaler (pMDI) actuators on asthma symptoms perception. There was no prespecified primary objective. The following objectives were assessed:
For both treatment periods, "baseline" for the questionnaire data was the 14-day period prior to the first treatment period, and for AQLQ was the value recorded at Visit 2.
This was a phase IIIb, exploratory, double-blind, randomised, multicentre, psychopharmacological, 2x2 cross-over study in adult subjects with moderate to severe asthma.
A total of 78 randomised subjects in 10 actives centres were involved. The study focused on the psychopharmacological aspects, particularly on the subjects' preference for the device and on the impact of the device's features on subjects' perception of asthma symptoms. Subjects were informed that the study treatments were the same medication they had received before enrolment as maintenance therapy (i.e. Foster® 100/6 µg pMDI), but with differing device characteristics.
The study lasted approximately 6 weeks for each subject and comprised four visits (Visit [V] 1 to V4), including:
After signing the ICF, subjects were screened at the investigational site during the screening/randomisation visit (V1). On the same day, and after checking all inclusion and exclusion criteria, eligible subjects were randomised to one of two study treatment sequences and followed the study treatment sequence as follows:
From V1 (Day 1), subjects were treated with commercial Foster® 100/6 µg pMDI during the 14-day baseline period;
From V2 (Day 15), subjects were instructed to take CHF1535 100/6 µg pMDI via Inhaler A and Inhaler B during two consecutive periods of 14 days each (first and second treatment periods) in a sequential way dictated by the randomisation:
The first treatment period started at V2 (Day 15) and the second treatment period started at V3 (Day 29), with the end of study visit taking place at V4 (Day 43). A window of ±1 day was allowed for the dates of all study visits except V1 (Day 1).
Please note that "Change from baseline in average VAS score perceptions of asthma-over the 14 Days of treatment - Question #3" was reported as PRIMARY ENDPOINT to comply with CT.gov register requirements, but it should be considered as an OTHER PRE-SPECIFIED endpoint like the other endpoint listed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence Inhaler A - Inhaler B (Period 1) | Experimental | Participants in this group first received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler A (white actuator) for a 14-day treatment period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator. After completing the first treatment period, participants switched to Inhaler B (pink actuator) for another 14 days. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate. There was no washout period between treatments, as the crossover design allowed a direct switch from one inhaler to the other without interruption. |
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| Sequence Inhaler B - Inhaler A (Period 2) | Active Comparator | Participants in this group first received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler B (pink actuator) for a 14-day treatment period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator. After completing the first treatment period, participants switched to Inhaler A (white actuator) for another 14-day treatment period. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate. There was no washout period between treatments, as the crossover design allowed a direct switch from one inhaler to the other without interruption. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A) | Drug | Administered via Inhaler A (white actuator) as two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. Delivered as a pressurized metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #3 | A study-specific questionnaire was developed to evaluate medication use, asthma symptoms, and treatment perception. It consisted of 16 questions, completed by subjects via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). The questionnaire included Visual Analogue Scale (VAS) ratings, numerical responses, and multiple-choice questions, with VAS primarily used to assess symptom perception and psychopharmacological effects. Question #3 (How would you score your asthma symptoms yesterday?) was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), with subjects rating their asthma symptoms from the previous day on a VAS scale from 0=no symptoms to 100=very symptomatic, with lower scores corresponding to better health. The overall value for each treatment period was defined as the average of the VAS scores collected over the two weeks of treatment within each period. Adjusted means are reported. | Baseline and Treatment Day 14 within each treatment period |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #4 | A study-specific questionnaire was developed to evaluate medication use, asthma symptoms, and treatment perception. It consisted of 16 questions, completed by subjects via an e-Diary. The questionnaire included Visual Analogue Scale (VAS) ratings, numerical responses, and multiple-choice questions, with VAS primarily used to assess symptom perception and psychopharmacological effects. Question #4 (How burdensome was your asthma yesterday?) was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), requiring subjects to rate the burden of their asthma symptoms from the previous day on a VAS scale ranging from 0 to 100, where 0=no burden at all and 100=very burdensome. Lower scores corresponded to better health and lower perceived burden of asthma. The overall value for each treatment period was defined as the average of the VAS scores collected over the two weeks of treatment within each period. Adjusted means by treatment are reported with their relative 95% IC. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Topole, MD | Chiesi Farmaceutici S.p.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiesi Clinical Trial Site 38011 | Bari | Italy | ||||
| Chiesi Clinical Trial Site 38009 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39772981 | Background | Blasi F, D'Amato M, Patella V, Topole E, Bucchioni E, Martini M, Geraci S, Grapin F, Van der Deijl M, Colloca L. Evaluating the impact of changing inhaler color on perception of symptoms and disease burden in patients with asthma: the FEEL study. J Asthma. 2025 May;62(5):841-849. doi: 10.1080/02770903.2024.2448317. Epub 2025 Jan 17. |
| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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After signing informed consent, patients underwent screening (V1) for eligibility. Eligible subjects entered a 14-day baseline period receiving all standardized treatment (CHF1535 100/6 µg pMDI) to ensure uniform background therapy. At V2 (Day 15), 78 subjects were randomized (A-B or B-A sequences). 3 patients failed screening, 4 discontinued before randomization, and 74 initiated treatment. Most randomized subjects received at least one dose of study treatment (Inhaler A= 72, Inhaler B = 74).
A total of 81 patients were screened. 78 patients were randomized into two treatment sequences:
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence: Inhaler A - Inhaler B | Participants received Beclomethasone dipropionate (BDP) 100 µg / Formoterol fumarate (FF) 6 µg pMDI (CHF1535 100/6 µg pMDI) fixed dose combo using Inhaler A (white actuator) for 14 days, from Day 15 to Day 29. They were instructed to take two puffs twice daily (morning & evening), for a total daily dose of 200 µg BDP and 12 µg FF. A pressurized solution with standard actuator was used. Afterwards, participants switched to Inhaler B (pink actuator) for another 14 days, from Day 29 to Day 43. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg BDP + 12 µg FF. BDP 100 µg / FF 6 µg (Inhaler A): Administered via Inhaler A (white actuator) as two puffs twice daily for a total daily dose of 200 µg BDP and 12 µg FF. Delivered as a pressurized metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study. BDP 100 µg / FF 6 µg (Inhaler B): Administered via Inhaler B (pink actuator) as two puffs twice daily for a total daily dose of 200 µg BDP and 12 µg FF. Delivered as a pressurized metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study. |
| FG001 | Sequence: Inhaler B - Inhaler A | Participants in this group began treatment with Beclomethasone dipropionate (BDP) 100 µg / Formoterol fumarate (FF) 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler B (pink actuator) for a 14-day period, from Day 15 to Day 29. They were instructed to take two puffs twice daily (morning & evening), for a total daily dose of 200 µg BDP and 12 µg FF. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator. Afterwards, participants switched to Inhaler A (white actuator) for another 14 days, from Day 29 to Day 43. Dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg BDP + 12 µg FF. BDP 100 µg / FF 6 µg (Inhaler A): Administered via Inhaler A (white actuator) as two puffs twice daily for a total daily dose of 200 µg BDP metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study. BDP 100 µg / FF 6 µg (Inhaler B): Administered via Inhaler B (pink actuator) as two puffs twice daily for a total daily dose of 200 µg BDP and 12 µg FF. Delivered as a pressurized metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
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| Overall Study |
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Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data just in one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence Inhaler A → Inhaler B (ITT Population) - Period 1 | Participants in this group first received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler A (white actuator) for a 14-day treatment period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator. After completing the first treatment period, participants switched to Inhaler B (pink actuator) for another 14 days. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #3 | A study-specific questionnaire was developed to evaluate medication use, asthma symptoms, and treatment perception. It consisted of 16 questions, completed by subjects via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). The questionnaire included Visual Analogue Scale (VAS) ratings, numerical responses, and multiple-choice questions, with VAS primarily used to assess symptom perception and psychopharmacological effects. Question #3 (How would you score your asthma symptoms yesterday?) was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), with subjects rating their asthma symptoms from the previous day on a VAS scale from 0=no symptoms to 100=very symptomatic, with lower scores corresponding to better health. The overall value for each treatment period was defined as the average of the VAS scores collected over the two weeks of treatment within each period. Adjusted means are reported. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account for the calculation of the treatment difference. n=71 is the number of patients with available data, not the general number of subjects in the ITT set (N=72 for Inhaler A and N=74 for the Inhaler B). | Posted | Mean | 95% Confidence Interval | score on a scale |
Throughout the study, from Visit 1 (Day 1 - study screening and along the baseline period [Day 1- Day 14]) until Visit 4 (Day 43 ± 1 day, i.e. the end of the second treatment period).
For pharmacovigilance purposes, all AEs were followed-up to elucidate as completely and practically as possible their nature and/or causality until resolution of all queries, clinical recovery was complete, laboratory results returned to normal, stable condition was reached or the subject was lost to follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhaler A - SAF Population | This arm includes all participants who received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pMDI (Inhaler A) during both treatment periods in the 2x2 crossover study. Total patients treated: 78 SAF set: 72 Period 1: 36 patients received Inhaler A first. Period 2: 36 patients received Inhaler A after switching from Inhaler B. Participants took two puffs twice daily (BID) for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate, using a pressurized metered-dose inhaler (pMDI). The study followed a randomized, double-blind, crossover design, with each treatment period lasting 14 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral discomfort | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial INFO | Chiesi Farmaceutici S.p.A. | +39 0521 2791 | clinicaltrials_info@chiesi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 14, 2021 | Jan 21, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 13, 2023 | Jan 21, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study
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Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study
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| Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B) | Drug | Administered via Inhaler B (pink actuator) as two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. Delivered as a pressurized metered-dose inhalation (pMDI) in a randomized, double-blind, crossover study. |
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| Baseline and Treatment Day 14 within each treatment period |
| Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #5 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #5 ("Did your asthma symptoms improve yesterday?") was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), using a VAS scale from 0 to 100 (0 = no improvement; 100 = maximum improvement), where higher scores indicated better health.The overall value for each treatment period was defined as the average of the VAS scores collected over the two weeks of treatment within each period. Adjusted means are reported with their 95% IC. | Baseline and Treatment Day 14 within each treatment period |
| Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #6 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #6 ("Did your asthma symptoms worsen yesterday?") was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), using a VAS scale from 0 to 100 (0 = no worsening; 100 = maximum worsening), where lower scores indicated better health. The overall value for each treatment period was defined as the average of the VAS scores collected over the two weeks of treatment within each period. Adjusted means are reported with their relative 95% IC. | Baseline and Treatment Day 14 within each treatment period |
| Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #3 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma symptoms were assessed using a VAS, ranging from 0=no symptoms to 100=very severe symptoms. Question #3 (How would you score your asthma symptoms yesterday?) was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43). First week value for each treatment period was defined as the average of the VAS scores that had been collected over the first week of treatment within each period. Change from baseline was calculated as the difference between the average VAS score from baseline (Day 1) and the average VAS score over the first 7 days of treatment. Adjusted means reported with their 95%IC. | Baseline and Treatment Day 7 within each treatment period |
| Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #4 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma burden was assessed using a Visual Analogue Scale (VAS) ranging from 0=no burden to 100=very burdensome condition. Lower scores corresponded to better health. Question #4 (How burdensome was your asthma yesterday?) was recorded daily in the morning over the first 7 days of treatment. First week value for each treatment period = average of the VAS scores collected over the first week of treatment within each period. Here the change from baseline was calculated as the difference between the average VAS score from baseline (Day 1) and the average VAS score over the first 7 days of treatment. | Baseline and Treatment Day 7 within each treatment period |
| Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #5 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma symptom improvement was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100, where 0 indicated no improvement at all and 100 indicated maximum improvement. Question #5 ("Did your asthma symptoms improve yesterday?") was recorded daily in the morning over the first 7 days of treatment. First week value for each treatment period was defined as the average of the VAS scores that had been collected over the first week of treatment within each period. The change from baseline was calculated as the difference between the average VAS score. Adjusted means are reported with their 95%IC | Baseline and Treatment Day 7 within each treatment period |
| Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #6 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma symptom worsening was assessed using a VAS, ranging from 0=no worsening at all to 100= maximum worsening. Question #6 (Did your asthma symptoms worsen yesterday?) was recorded daily in the morning over the first 7 days of treatment. First week value for each treatment period was defined as the average of the VAS scores that had been collected over the first week of treatment within each period. The change from baseline was calculated as the difference between the average VAS score from baseline (Day 1) and the average VAS score over the first 7 days of treatment. Adjusted means are reported. | Baseline and Treatment Day 7 within each treatment period |
| Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #7 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #7 (Do you expect any improvement in asthma symptoms with this treatment?) was recorded at V2 (Day 15) and V3 (Day 29), before starting each treatment period. Expected asthma symptom improvement was assessed using a Visual Analogue Scale (VAS) ranging from 0=no expected improvement to 100=maximum expected improvement. Higher scores corresponded to greater expectations of benefit.Summary measures for this question were presented separately as descriptive statistics for the ITT population. | Baseline - V2 (Day 15) |
| Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #8 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #8 (Do you expect any worsening of your asthma symptoms with this treatment?) was recorded at V2 (Day 15) and V3 (Day 29), before starting each treatment period. Expected asthma symptom improvement was assessed using a Visual Analogue Scale (VAS) ranging from 0=none to 100=maximum worsening. Lower scores corresponded to better health. Summary measures for this question were presented separately as descriptive statistics for the ITT population. | Baseline - V2 (Day 15) |
| Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #9 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #9 ("How much do you think this treatment improved your overall asthma symptoms?") was recorded at V3 (Day 29) and V4 (Day 43), after each treatment period. Perceived improvement in overall asthma symptoms was assessed using a Visual Analogue Scale (VAS) ranging from 0 = none to 100 = maximum improvement. Higher scores corresponded to better health. Summary measures for this question were presented separately as descriptive statistics for the ITT population. | Study Day 14 of each treatment period |
| Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #10 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #10 ("How much do you think this treatment worsened your overall asthma symptoms?") was recorded at V3 (Day 29) and V4 (Day 43), after each treatment period. Perceived worsening of overall asthma symptoms was assessed using a Visual Analogue Scale (VAS) ranging from 0 = none to 100 = maximum worsening. Lower scores corresponded to better health. Summary measures for this question were presented separately as descriptive statistics for the ITT population. | Study Day 14 of each treatment period (V3 - Day 29 for Period 1 and V4 - Day 43 Period 2) |
| Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #11 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions was completed via an e-Diary. Questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' visual preference for the inhalers was assessed through Question #11 ("Which inhaler did you visually prefer?"). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Inhaler A, Inhaler B, or No preference. The number and percentage of subjects selecting one of the three options was summarized separately for the ITT population by treatment group. | Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview) |
| Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #12 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' preference for inhaler use was assessed through Question #12 ("Which inhaler did you prefer to use?"), which was answered only at V4 (Day 43). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Inhaler A, Inhaler B, or No preference. The number and percentage of subjects selecting one of the three options was summarized separately for the ITT population by treatment group. | Day 43 (V4, i.e.at the end of the entire treatment period during the Exit Interview) |
| Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #13 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of changes in the inhalers was assessed through Question #13 ("Do you think that changes were made to the inhalers?"), which was answered only at V4 (Day 43). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Yes, No, or I don't know. The number and percentage of subjects selecting one of the three options was summarized separately for the ITT population by treatment group. | Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview) |
| Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #14 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of the impact of inhaler changes on asthma symptoms was assessed through Question #14 ("Do you think that changes made across the inhalers have impacted your asthma symptoms?"), which was answered only at V4 (Day 43). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Yes, No, or I don't know. The number and % of subjects selecting one of the options was summarized separately for the ITT population by treatment group. | Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview) |
| Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #15 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of asthma symptoms after receiving information about the inhalers was assessed through Question #15 ("Based on the information you have received, did it impact your perception of your asthma symptoms?"), which was answered only at V4 (Day 43), after revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Yes, No, or I don't know. The number and % of subjects selecting one of the options was summarized separately for the ITT population by treatment group. | Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview) |
| Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #16 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of which inhaler had the biggest impact on their asthma symptoms was assessed through Question #16 ("Which of Inhaler A or Inhaler B had the biggest impact on the perception of your asthma symptoms?"), which was answered only at V4 (Day 43), after revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Inhaler A, Inhaler B, or I don't know. The number and % of subjects selecting one of the 3 options was reported separately by treatment group. | Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview) |
| Change From Baseline in Average Reliever Medication Use - Over the Entire 14-day Treatment - Question #2 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while others were answered at specific study visit timepoints. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Rescue medication use was assessed through Question #2 (How many puffs of rescue medication have you taken yesterday?), answered daily every morning throughout the entire 14-day treatment period, from the day after V1 (Day 2) to the end of the study at V4 (Day 43). The average number of puffs per day was calculated for both the baseline and treatment periods, and the change from baseline was summarized separately for the ITT population by treatment group. Average value for each treatment period = mean number of puffs per day collected over Study Day 1 to Study Day 14 of each treatment period. | Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 for Period 2) |
| Change From Baseline in AQLQ Activity Limitation Score - After 14 Days of Treatment | Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains:
AQLQ was administered at V2 (Day15) and V3 (Day29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered:
| Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2) |
| Change From Baseline in AQLQ Symptoms Score - After 14 Days of Treatment | Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains:
AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered:
| Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2) |
| Change From Baseline in AQLQ Emotional Function Score - After 14 Days of Treatment | Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains:
AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered:
| Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2) |
| Change From Baseline in AQLQ Environmental Stimuli Score - After 14 Days of Treatment | Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains:
AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered:
| Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2) |
| Change From Baseline in AQLQ Overall Score - After 14 Days of Treatment | Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains:
AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). Overall score = Σ scores of each 32 domains/ no. of available items in overall AQLQ (0-1) | Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2) |
| Occurrence of Treatment Emergent Adverse Event (TEAEs), Adverse Drug Reactions (ADRs), Severe ADRs, Serious ADRs, Serious TEAEs (Serious Adverse Events), Non-serious TEAEs, Severe TEAEs | An adverse event (AE) was defined as "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment". An AE could therefore be any unfavourable and unintended sign (including abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An adverse drug reaction (ADR) was defined as an "untoward and unintended response to an investigational medicinal product related to any dose administered". A serious adverse event (SAE)/serious ADR was defined as any untoward medical occurrence or effect that at any dose: Resulted in death; Was life-threatening; Required hospitalisation or prolongation of existing hospitalisation; Resulted in persistent or significant disability or incapacity; Was a congenital anomaly or birth defect; Was a medically significant AE. | From V1 (Day 1) to V4 (Day 43) |
| Battipaglia |
| Italy |
| Chiesi Clinical Trial Site 38006 | Cagliari | Italy |
| Chiesi Clinical Trial Site 38010 | Catanzaro | Italy |
| Chiesi Clinical Trial Site 38003 | Genova | Italy |
| Chiesi Clinical Trial Site 38001 | Milan | Italy |
| Chiesi Clinical Trial Site 38005 | Naples | Italy |
| Chiesi Clinical Trial Site 38004 | Palermo | Italy |
| Chiesi Clinical Trial Site 38002 | Roma | Italy |
| Chiesi Clinical Trial Site 38007 | Sassari | Italy |
| Other Reason |
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| BG001 | Sequence Inhaler B → Inhaler A (ITT Population) - Period 2 | Participants in this group began treatment with Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler B (pink actuator) for a 14-day period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator. At the end of the first 14-day treatment period, participants switched to Inhaler A (white actuator) for another 14 days. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate. |
| BG002 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline and Treatment Day 14 within each treatment period |
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| Other Pre-specified | Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #4 | A study-specific questionnaire was developed to evaluate medication use, asthma symptoms, and treatment perception. It consisted of 16 questions, completed by subjects via an e-Diary. The questionnaire included Visual Analogue Scale (VAS) ratings, numerical responses, and multiple-choice questions, with VAS primarily used to assess symptom perception and psychopharmacological effects. Question #4 (How burdensome was your asthma yesterday?) was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), requiring subjects to rate the burden of their asthma symptoms from the previous day on a VAS scale ranging from 0 to 100, where 0=no burden at all and 100=very burdensome. Lower scores corresponded to better health and lower perceived burden of asthma. The overall value for each treatment period was defined as the average of the VAS scores collected over the two weeks of treatment within each period. Adjusted means by treatment are reported with their relative 95% IC. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account for the calculation of the treatment difference. n=71 is the number of patients with available data, not the general number of subjects in the ITT set (N=72 for Inhaler A and N=74 for the Inhaler B). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and Treatment Day 14 within each treatment period |
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| Other Pre-specified | Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #5 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #5 ("Did your asthma symptoms improve yesterday?") was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), using a VAS scale from 0 to 100 (0 = no improvement; 100 = maximum improvement), where higher scores indicated better health.The overall value for each treatment period was defined as the average of the VAS scores collected over the two weeks of treatment within each period. Adjusted means are reported with their 95% IC. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account for the calculation of the treatment difference. n=71 is the number of patients with available data, not the general number of subjects in the ITT set (N=72 for Inhaler A and N=74 for the Inhaler B). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and Treatment Day 14 within each treatment period |
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| Other Pre-specified | Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #6 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #6 ("Did your asthma symptoms worsen yesterday?") was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), using a VAS scale from 0 to 100 (0 = no worsening; 100 = maximum worsening), where lower scores indicated better health. The overall value for each treatment period was defined as the average of the VAS scores collected over the two weeks of treatment within each period. Adjusted means are reported with their relative 95% IC. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account for the calculation of the treatment difference. n=71 is the number of patients with available data, not the general number of subjects in the ITT set (N=72 for Inhaler A and N=74 for the Inhaler B). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and Treatment Day 14 within each treatment period |
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| Other Pre-specified | Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #3 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma symptoms were assessed using a VAS, ranging from 0=no symptoms to 100=very severe symptoms. Question #3 (How would you score your asthma symptoms yesterday?) was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43). First week value for each treatment period was defined as the average of the VAS scores that had been collected over the first week of treatment within each period. Change from baseline was calculated as the difference between the average VAS score from baseline (Day 1) and the average VAS score over the first 7 days of treatment. Adjusted means reported with their 95%IC. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account for the calculation of the treatment difference. n=71 is the number of patients with available data, not the general number of subjects in the ITT set (N=72 for Inhaler A and N=74 for the Inhaler B). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and Treatment Day 7 within each treatment period |
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| Other Pre-specified | Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #4 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma burden was assessed using a Visual Analogue Scale (VAS) ranging from 0=no burden to 100=very burdensome condition. Lower scores corresponded to better health. Question #4 (How burdensome was your asthma yesterday?) was recorded daily in the morning over the first 7 days of treatment. First week value for each treatment period = average of the VAS scores collected over the first week of treatment within each period. Here the change from baseline was calculated as the difference between the average VAS score from baseline (Day 1) and the average VAS score over the first 7 days of treatment. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account for the calculation of the treatment difference. n=71 is the number of patients with available data, not the general number of subjects in the ITT set (N=72 for Inhaler A and N=74 for the Inhaler B). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and Treatment Day 7 within each treatment period |
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| Other Pre-specified | Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #5 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma symptom improvement was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100, where 0 indicated no improvement at all and 100 indicated maximum improvement. Question #5 ("Did your asthma symptoms improve yesterday?") was recorded daily in the morning over the first 7 days of treatment. First week value for each treatment period was defined as the average of the VAS scores that had been collected over the first week of treatment within each period. The change from baseline was calculated as the difference between the average VAS score. Adjusted means are reported with their 95%IC | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account for the calculation of the treatment difference. n=71 is the number of patients with available data, not the general number of subjects in the ITT set (N=72 for Inhaler A and N=74 for the Inhaler B). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and Treatment Day 7 within each treatment period |
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| Other Pre-specified | Change From Baseline in Average VAS Score Perceptions of Asthma - Over the First 7 Days of Treatment - Question #6 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Asthma symptom worsening was assessed using a VAS, ranging from 0=no worsening at all to 100= maximum worsening. Question #6 (Did your asthma symptoms worsen yesterday?) was recorded daily in the morning over the first 7 days of treatment. First week value for each treatment period was defined as the average of the VAS scores that had been collected over the first week of treatment within each period. The change from baseline was calculated as the difference between the average VAS score from baseline (Day 1) and the average VAS score over the first 7 days of treatment. Adjusted means are reported. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and Treatment Day 7 within each treatment period |
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| Other Pre-specified | Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #7 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #7 (Do you expect any improvement in asthma symptoms with this treatment?) was recorded at V2 (Day 15) and V3 (Day 29), before starting each treatment period. Expected asthma symptom improvement was assessed using a Visual Analogue Scale (VAS) ranging from 0=no expected improvement to 100=maximum expected improvement. Higher scores corresponded to greater expectations of benefit.Summary measures for this question were presented separately as descriptive statistics for the ITT population. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period. | Posted | Mean | Standard Deviation | score on a scale | Baseline - V2 (Day 15) |
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| Other Pre-specified | Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #8 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #8 (Do you expect any worsening of your asthma symptoms with this treatment?) was recorded at V2 (Day 15) and V3 (Day 29), before starting each treatment period. Expected asthma symptom improvement was assessed using a Visual Analogue Scale (VAS) ranging from 0=none to 100=maximum worsening. Lower scores corresponded to better health. Summary measures for this question were presented separately as descriptive statistics for the ITT population. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period. | Posted | Mean | Standard Deviation | score on a scale | Baseline - V2 (Day 15) |
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| Other Pre-specified | Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #9 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #9 ("How much do you think this treatment improved your overall asthma symptoms?") was recorded at V3 (Day 29) and V4 (Day 43), after each treatment period. Perceived improvement in overall asthma symptoms was assessed using a Visual Analogue Scale (VAS) ranging from 0 = none to 100 = maximum improvement. Higher scores corresponded to better health. Summary measures for this question were presented separately as descriptive statistics for the ITT population. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period. | Posted | Mean | Standard Deviation | score on a scale | Study Day 14 of each treatment period |
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| Other Pre-specified | Summary Measures for Questions With Continuous Outcomes Covering Subject's Psychopharmacological Aspects - Question #10 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while psychopharmacological questions were answered only at specific study visit timepoints (two questions at V2-Day 15, four at V3-Day 29, and two at V4-Day 43). It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Question #10 ("How much do you think this treatment worsened your overall asthma symptoms?") was recorded at V3 (Day 29) and V4 (Day 43), after each treatment period. Perceived worsening of overall asthma symptoms was assessed using a Visual Analogue Scale (VAS) ranging from 0 = none to 100 = maximum worsening. Lower scores corresponded to better health. Summary measures for this question were presented separately as descriptive statistics for the ITT population. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period. | Posted | Mean | Standard Deviation | score on a scale | Study Day 14 of each treatment period (V3 - Day 29 for Period 1 and V4 - Day 43 Period 2) |
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| Other Pre-specified | Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #11 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions was completed via an e-Diary. Questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' visual preference for the inhalers was assessed through Question #11 ("Which inhaler did you visually prefer?"). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Inhaler A, Inhaler B, or No preference. The number and percentage of subjects selecting one of the three options was summarized separately for the ITT population by treatment group. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account. Please note that N = Number of subjects (74) in the ITT set; while n = number of subjects with available data (58) | Posted | Count of Participants | Participants | Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview) |
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| Other Pre-specified | Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #12 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' preference for inhaler use was assessed through Question #12 ("Which inhaler did you prefer to use?"), which was answered only at V4 (Day 43). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Inhaler A, Inhaler B, or No preference. The number and percentage of subjects selecting one of the three options was summarized separately for the ITT population by treatment group. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account. Please note that N = Number of subjects (74) in the ITT set; while n = number of subjects with available data (58) | Posted | Count of Participants | Participants | Day 43 (V4, i.e.at the end of the entire treatment period during the Exit Interview) |
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| Other Pre-specified | Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #13 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of changes in the inhalers was assessed through Question #13 ("Do you think that changes were made to the inhalers?"), which was answered only at V4 (Day 43). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Yes, No, or I don't know. The number and percentage of subjects selecting one of the three options was summarized separately for the ITT population by treatment group. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account. Please note that N = Number of subjects (74) in the ITT set; while n = number of subjects with available data (58) | Posted | Count of Participants | Participants | Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview) |
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| Other Pre-specified | Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #14 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of the impact of inhaler changes on asthma symptoms was assessed through Question #14 ("Do you think that changes made across the inhalers have impacted your asthma symptoms?"), which was answered only at V4 (Day 43). The question was completed before revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Yes, No, or I don't know. The number and % of subjects selecting one of the options was summarized separately for the ITT population by treatment group. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account. Please note that N = Number of subjects (74) in the ITT set; while n = number of subjects with available data (58) | Posted | Count of Participants | Participants | Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview) |
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| Other Pre-specified | Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #15 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of asthma symptoms after receiving information about the inhalers was assessed through Question #15 ("Based on the information you have received, did it impact your perception of your asthma symptoms?"), which was answered only at V4 (Day 43), after revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Yes, No, or I don't know. The number and % of subjects selecting one of the options was summarized separately for the ITT population by treatment group. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account. Please note that N = Number of subjects (74) in the ITT set; while n = number of subjects with available data (58) | Posted | Count of Participants | Participants | Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview) |
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| Other Pre-specified | Count of Subjects for Questions Covering Subjects' Preference and Perception of the Devices - Question #16 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while questions related to device preference and perception were answered only at V4 (Day 43) during the Exit Interview. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Subjects' perception of which inhaler had the biggest impact on their asthma symptoms was assessed through Question #16 ("Which of Inhaler A or Inhaler B had the biggest impact on the perception of your asthma symptoms?"), which was answered only at V4 (Day 43), after revealing that the only difference between the inhalers was the color of the actuator. Subjects could choose between Inhaler A, Inhaler B, or I don't know. The number and % of subjects selecting one of the 3 options was reported separately by treatment group. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account. Please note that N = Number of subjects (74) in the ITT set; while n = number of subjects with available data (58) | Posted | Count of Participants | Participants | Day 43 (V4, i.e. at the end of the entire treatment period during the Exit Interview) |
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| Other Pre-specified | Change From Baseline in Average Reliever Medication Use - Over the Entire 14-day Treatment - Question #2 | A study-specific questionnaire assessed medication use, asthma symptoms, and treatment perception through 16 questions completed via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), while others were answered at specific study visit timepoints. It included VAS, numerical, and multiple-choice questions, with VAS used for symptom perception and psychopharmacological effects. Rescue medication use was assessed through Question #2 (How many puffs of rescue medication have you taken yesterday?), answered daily every morning throughout the entire 14-day treatment period, from the day after V1 (Day 2) to the end of the study at V4 (Day 43). The average number of puffs per day was calculated for both the baseline and treatment periods, and the change from baseline was summarized separately for the ITT population by treatment group. Average value for each treatment period = mean number of puffs per day collected over Study Day 1 to Study Day 14 of each treatment period. | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period. | Posted | Mean | Standard Deviation | puffs/day | Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 for Period 2) |
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| Other Pre-specified | Change From Baseline in AQLQ Activity Limitation Score - After 14 Days of Treatment | Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains:
AQLQ was administered at V2 (Day15) and V3 (Day29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered:
| Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2) |
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| Other Pre-specified | Change From Baseline in AQLQ Symptoms Score - After 14 Days of Treatment | Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains:
AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered:
| Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2) |
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| Other Pre-specified | Change From Baseline in AQLQ Emotional Function Score - After 14 Days of Treatment | Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains:
AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered:
| Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2) |
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| Other Pre-specified | Change From Baseline in AQLQ Environmental Stimuli Score - After 14 Days of Treatment | Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains:
AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). The AQLQ scores were calculated as follows: Domain score = Σ scores for all items in the domain / no. of available items in that domain (0-1) AQLQ response was considered:
| Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2) |
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| Other Pre-specified | Change From Baseline in AQLQ Overall Score - After 14 Days of Treatment | Asthma Quality of Life Questionnaire (AQLQ), a fully validated disease-specific tool designed to assess physical and emotional impact of asthma in adults. AQLQ consists of 32 questions divided into 4 domains:
AQLQ was administered at V2 (Day 15) and V3 (Day 29) via remote video calls, and V4 (Day43) via a face-to-face visit. The baseline value was defined as the last available score collected at the baseline period end (V2, Day15). Overall score = Σ scores of each 32 domains/ no. of available items in overall AQLQ (0-1) | Intention-to-treat (ITT) set: all randomised subjects who received at least one dose of the study treatment and with at least one available evaluation of efficacy after the baseline. Using this definition, subjects with data in just one treatment period were not taken into account by the statistical models for the calculation of the treatment difference. The ITT set analyses were based on the randomised treatment for each period. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Study Day 14 of each treatment period (to Day 29 for Period 1 and to Day 43 Period 2) |
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| Other Pre-specified | Occurrence of Treatment Emergent Adverse Event (TEAEs), Adverse Drug Reactions (ADRs), Severe ADRs, Serious ADRs, Serious TEAEs (Serious Adverse Events), Non-serious TEAEs, Severe TEAEs | An adverse event (AE) was defined as "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment". An AE could therefore be any unfavourable and unintended sign (including abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An adverse drug reaction (ADR) was defined as an "untoward and unintended response to an investigational medicinal product related to any dose administered". A serious adverse event (SAE)/serious ADR was defined as any untoward medical occurrence or effect that at any dose: Resulted in death; Was life-threatening; Required hospitalisation or prolongation of existing hospitalisation; Resulted in persistent or significant disability or incapacity; Was a congenital anomaly or birth defect; Was a medically significant AE. | Safety set: all randomised subjects who received at least one dose of study treatment in a period. Analyses based on the Safety set were based on the actual treatment received per period. | Posted | Count of Participants | Participants | From V1 (Day 1) to V4 (Day 43) |
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| 0 |
| 72 |
| 0 |
| 72 |
| 7 |
| 72 |
| EG001 | Inhaler B - SAF Population | This arm includes all participants who received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pMDI (Inhaler B) during both treatment periods in the 2x2 crossover study. Total patients treated: 78 SAF set: 74 Period 1: 38 patients received Inhaler B first. Period 2: 36 patients received Inhaler B after switching from Inhaler A. Participants took two puffs twice daily (BID) for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate, using a pressurized metered-dose inhaler (pMDI). The study followed a randomized, double-blind, crossover design, with each treatment period lasting 14 days | 0 | 74 | 0 | 74 | 6 | 74 |
| EG002 | Overall | Safety analyses were conducted in the Safety set which included 74 subjects overall | 0 | 74 | 0 | 74 | 11 | 74 |
| Chest discomfort | General disorders | MedDRA (24.0) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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Results of this study may be published or presented at scientific meetings. If a publication is presented by the Investigator, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Data from individual study sites must not be published separately.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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| Non-serious TEAE |
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| ADR |
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| Serious ADR |
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| Severe ADR |
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| Severe TEAE |
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| TEAE leading to discontinuation of study treatment |
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| TEAE leading to death |
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