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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524289-56-00 | EU Trial (CTIS) Number |
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This study will evaluate the effect of triple ICS/LAMA/LABA therapy with a BDP/FF/GB 100/6/12.5 µg on asthma control outcomes relative to ICS/LABA therapy with BDP/FF 200/6 μg in a population with asthma poorly controlled.
This is a phase IV, pragmatic, randomized, open-label, 2-arm parallel group, multi-center. The study aims to compare BDP/FF/GB pMDI 100/6/12.5 µg BID with BDP/FF pMDI 200/6 μg BID in adult participants with asthma poorly controlled, using medium dose ICS/LABA for at least 3 months prior randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BDP/FF/GB | Active Comparator | Trimbow® 87/5/9 pMDI (BDP/FF/GB 100/6/12.5 µg) - 2 inhalations bid |
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| BDP/FF | Active Comparator | Foster® 200/6 pMDI (BDP/FF 200/6 µg) - 2 inhalations bid |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation) | Drug | Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide BDP/FF/GB (100/6/12.5 µg per actuation) administered via pressurised metered-dose inhaler (pMDI) 2 inhalations bid (i.e. 2 inhalations in the morning and 2 inhalations in the evening) for a total of 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ACQ-5 score | To demonstrate non inferiority of BDP/FF/GB-100/6/12.5 µg compared to BDP/FF-200/6 µg in terms of change in the Asthma Control Questionnaire-5 (ACQ-5) at Visit 7 (i.e. at Month 12) versus baseline. ACQ-5 is a one-week recall questionnaire including 5 patient-reported questions, each scored on a 7-point scale (0 = no impairment, 6 = maximum impairment). All questions are equally weighted, and the ACQ-5 score is calculated as the mean of the 5 responses, resulting in a total score ranging from 0 (totally controlled) to 6 (severely uncontrolled). | Baseline to Month 12 (Visit 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ACQ-5 at all applicable visits. | Change from baseline in ACQ-5 at all applicable visits. Asthma Control Questionnaire-5 is a one-week recall questionnaire including 5 patient-reported questions, each scored on a 7-point scale (0 = no impairment, 6 = maximum impairment). All questions are equally weighted, and the ACQ-5 score is calculated as the mean of the 5 responses, resulting in a total score ranging from 0 (totally controlled) to 6 (severely uncontrolled). |
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Inclusion Criteria:
1 . Study participant's written informed consent obtained prior to any study related procedure.
2. Male or female study participants aged ≥18 years old. 3. Physician confirmed documented asthma diagnosis as per current clinical practice.
4. Stable asthma treatment prior randomisation: At least 3 months on any medium strength (MS) ICS/LABA regular treatment.
5. Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year).
6. Women with childbearing potential (WOCBP) and with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the last visit.
7. Study participants must have a cooperative attitude and the ability to be trained to use the patient app correctly, to be able to perform the required outcomes measurements (e.g. ePRO completion) and the ability to understand the risks involved.
Note: Study participants with asthma diagnosis and no clinically relevant concurrent COPD diagnosis upon clinical judgement can be included. Study participants on maintenance and reliever therapy (MART) can be included if the ICS dosage does not exceed 400 µg/day of beclometasone or equivalent.
Exclusion Criteria: The presence of any of the following will exclude a study participant from study enrolment:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial INFO Chiesi Farmaceutici S.p.A. | Contact | +39 0521 2791 | clinicaltrials_info@chiesi.com |
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Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
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This is a Phase IV, pragmatic, randomized, open-label, 2-arm parallel group, multi-center prospective study comparing BDP/FF/GB pMDI 100/6/12.5 µg BID with BDP/FF pMDI 200/6 μg BID in adults participants with asthma poorly controlled, using medium dose ICS/LABA for at least 3 months prior randomization.
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| Foster® 200/6 pMDI (BDP/FF-200/6 µg) | Drug | Beclometasone dipropionate, formoterol fumarate (BDP/FF-200/6 µg) administered via pressurised metered-dose inhaler (pMDI) 2 inhalations bid (i.e. 2 inhalations in the morning and 2 inhalations in the evening) for a total of 12 months. |
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| Baseline to Month 12 (Visit 7) |
| Rate of severe asthma exacerbations | Rate of severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months. | Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7) |
| Rate of moderate/severe asthma exacerbations | Rate of moderate/severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months | Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7) |
| Time to first severe asthma exacerbation. | Time to first severe asthma exacerbation. | Month 12 treatment period |
| Time to first moderate/severe asthma exacerbation. | Time to first moderate/severe asthma exacerbation. | Month 12 treatment period |
| Speed of change questionnaire at each applicable study visit. | Speed of change questionnaire at each applicable study visit. | Month 12 treatment period |
| Eosinophils value | Change from baseline in eosinophils value at each applicable study visit. | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Oral systemic corticosteroids days | Number of days with oral systemic corticosteroids | Month 12 treatment period |
| Change from baseline in Test of Adherence to Inhalers (TAI) questionnaire at each applicable visit. | Test of Adherence to Inhalers (TAI) questionnaire change. The TAI-10 score is automatically calculated on the electronic device by summing the individual item scores (1-10) ranging from 10-50, with higher score indicating better adherence. The TAI 12-item total score is derived manually as sum of TAI-10 total score and items 11 and 12 scores. | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in quality-of-life questionnaire: EQ-5D-5L | EQ-5D-5L = EuroQol 5-Dimension 5-Level: index values range from <0 to 1 (higher values indicate better health), and EQ VAS scores range from 0 to 100 (higher scores indicate better self-rated health). | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Chronic Airways Assessment Test (CAAT) | CAAT questionnaire consists of 8 items scored from 0 to 5, with a total score ranging from 0 to 40; higher scores indicate worse health status. | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Cardiovascular Event Rate | Percentage of study participants with cardiovascular and/or fatal events (considering standard adverse event [AE] data collection) | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Asthma remission rate | Percentage of study participants with partial and complete asthma remission at 6 and 12 months. | Month 6 (Visit 4), Month 12 (Visit 7) |
| Change in Spirometry parameters: FEV1 | Pulmonary function tests measured by spirometry: FEV1 (forced expiratory volume in 1 second), expressed as volume (L). | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Spirometry parameters: FVC | Pulmonary function tests measured by spirometry: FVC (forced vital capacity), expressed as volume (L). | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Spirometry parameters: FEV1/FVC ratio | Pulmonary function tests measured by spirometry: FEV1/FVC ratio, expressed as a percentage (%). | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Spirometry parameters: FEF25-75 | Pulmonary function tests measured by spirometry: FEF25-75 (forced expiratory flow between 25% and 75% of FVC), expressed as flow (L/s). | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Spirometry parameters: ratio of FEF25-75 to FVC | Pulmonary function tests measured by spirometry: ratio of FEF25-75 to FVC. | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Spirometry parameters: FEV1% | Pulmonary function tests measured by spirometry: FEV1 as percentage of predicted normal values (%). | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Spirometry parameters: FVC% of predicted normal | Pulmonary function tests measured by spirometry: FVC as percentage of predicted normal values (%). | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Oscillometry parameters- R5 (Total airway resistance) | Pulmonary function tests measured by oscillometry: Resistance at 5 Hz (R5), representing total airway resistance, expressed in kPa·L-¹·s. | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Oscillometry parameters- R20 (Central airway resistance) | Pulmonary function tests measured by oscillometry: Resistance at 20 Hz (R20), representing central airway resistance, expressed in kPa·L-¹·s. | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Oscillometry parameters- R5-R20 (Peripheral airway resistance) | Pulmonary function tests measured by oscillometry: Difference between resistance at 5 Hz and 20 Hz (R5-R20), representing peripheral airway resistance, expressed in kPa·L-¹·s. | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Oscillometry parameters-X5 (Reactance) | Pulmonary function tests measured by oscillometry: Reactance at 5 Hz (X5), reflecting distal airway reactance, expressed in kPa·L-¹·s. | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Oscillometry parameters-Fres (Resonant frequency) | Pulmonary function tests measured by oscillometry: Resonant frequency (Fres), defined as the frequency at which reactance equals zero, expressed in Hz | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Change in Oscillometry parameters-AX (Area of reactance) | Pulmonary function tests measured by oscillometry: Area of reactance (AX), representing the integrated low-frequency reactance, expressed in Hz·kPa·L-¹·s. | Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7) |
| Oral systemic corticosteroids dose | Dose of oral systemic corticosteroids (mg) | Month 12 treatment period |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| D000068759 | Formoterol Fumarate |
| D006024 | Glycopyrrolate |
| D005581 | Foster Home Care |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D000644 | Quaternary Ammonium Compounds |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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