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The purpose of this study was to provide long term safety data of QMF149 in Japanese participants with inadequately controlled asthma for the registration of QMF149 in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QMF149 | Experimental | All eligible patients take QMF149 150/320 μg once daily over 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QMF149 | Drug | QMF149 150/320 μg once daily, delivered as powder in hard capsules via Concept1 inhaler |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | A TEAE is any adverse event that started on or after the time of the first inhalation of study drug but not later than 7 days (30 days in the case of a SAE) after the last administration. A SAE is described as any adverse event that leads to death, is life-threatening, results in persistent or significant disability/incapacity, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event which is medically significant. | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Pre-Dose Forced Expiratory Volume in 1 Second (FEV1) Measured After 26 And 52 Weeks Treatment | The pre-dose FEV1 was defined as the mean of the pre-dose 45 and 15 min FEV1 values prior to evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV1 indicates improvement in lung function. |
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Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed.
Male and female adult patient ≥ 18 years old.
Patients with a diagnosis of persistent asthma for a period of at least 1 year prior to Visit 1.
Patients who have used medium or high dose inhaled corticosteroids (ICS) plus at least 1 controller for asthma for at least 3 months and at stable dose and regimen for at least 4 weeks prior to Visit 1.
Patients must have Asthma Control Questionnaire-7 (ACQ-7) score ≥ 1.5 at Visits 2 and qualify for treatment with high dose ICS/long-acting β2 agonist (LABA).
Pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) of ≥ 50% and ≤ 85% of the predicted normal value for the patient after withholding bronchodilators at Visit 2.
Repeating is allowed once only. Repeating of percentage predicted FEV1 should be done in an ad-hoc visit to be scheduled on a date that would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment before Visit 99.
Patients must demonstrate reversibility defined as an increase in FEV1 of ≥ 12% and 200 mL within 15 to 30 minutes after administration of 400 µg of salbutamol at Visit 2. Spacer devices are permitted during reversibility testing only. The Investigator or delegate may decide whether or not to use a spacer for the reversibility testing.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 457-8511 | Japan | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | QMF-149 150/320 μg | QMF-149 150/320 μg delivered as powder in hard capsules, once daily via Concept1 inhaler. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Set consisted of all participants who received at least one dose of study medication during this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | QMF-149 150/320 μg | QMF-149 150/320 μg delivered as powder in hard capsules, once daily via Concept1 inhaler. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | A TEAE is any adverse event that started on or after the time of the first inhalation of study drug but not later than 7 days (30 days in the case of a SAE) after the last administration. A SAE is described as any adverse event that leads to death, is life-threatening, results in persistent or significant disability/incapacity, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event which is medically significant. | Safety Set consisted of all participants who received at least one dose of study medication during this study. | Posted | Count of Participants | Participants | Up to 52 weeks |
|
Up to 52 weeks
Safety Set consisted of all participants who received at least one dose of study medication during this study.
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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 | QMF149 150/320 µg | QMF-149 150/320 μg delivered as powder in hard capsules, once daily via Concept1 inhaler. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2018 | Jan 27, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 15, 2017 | Jan 27, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000600413 | QMF149 |
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| Baseline, Weeks 26 and 52 |
| Change From Baseline of Morning and Evening Peak Expiratory Flow (PEF) During 52 Weeks Treatment | PEF is the greatest airflow rate achieved during forced exhalation with lungs fully inflated. PEF was analyzed separately in the morning and evening using an electronic Peak Flow Meter (ePEF). A positive change from baseline in PEF indicates improvement in lung function. | Baseline up to Week 52 |
| Change From Baseline of Asthma Control Questionnaire (ACQ-7) After 26 And 52 Weeks Treatment | The ACQ-7 is a seven-item disease-specific instrument developed and validated to assess asthma control in participants. It consists of five items to assess symptoms and activity limitations, one question to assess rescue medication use, and one question to assess airway caliber (FEV1% predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question (question 7) was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function. | Baseline, Weeks 26 and 52 |
| Responder Rate of Participants Achieving the Minimal Important Difference (MID) of ACQ-7 ≥ 0.5 After 26 And 52 Weeks Treatment | The ACQ-7 is a seven-item disease-specific instrument developed and validated to assess asthma control in participants. It consists of five items to assess symptoms and activity limitations, one question to assess rescue medication use, and one question to assess airway caliber (FEV1% predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question (question 7) was completed by the study investigator using data from the Master Scope spirometer. The proportion of participants who achieved an improvement of at least 0.5 in ACQ-7 (i.e. decrease of ACQ-7 score of at least 0.5 from baseline) at post-baseline visits were analyzed. | Weeks 26 and 52 |
| Change From Baseline of Rescue Medication Use During 52 Weeks Treatment | Based on the electronic-diary data, the total number of puffs of rescue medication per day over the 52 weeks were calculated and divided by the total number of days to derive the mean daily number of puffs of rescue medication taken for the participant. | Baseline up to Week 52 |
| Fukuoka |
| Fukuoka |
| 819-8555 |
| Japan |
| Novartis Investigative Site | Chitose | Hokkaido | 066-0021 | Japan |
| Novartis Investigative Site | Kitahiroshima | Hokkaido | 061-1121 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 006-0811 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 064-0801 | Japan |
| Novartis Investigative Site | Takamatsu | Kagawa-ken | 760-0018 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 223-0059 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 231-8682 | Japan |
| Novartis Investigative Site | Yokosuka | Kanagawa | 239-0821 | Japan |
| Novartis Investigative Site | Chino | Nagano | 391-0011 | Japan |
| Novartis Investigative Site | Higashiosaka | Osaka | 577-0843 | Japan |
| Novartis Investigative Site | Chuo Ku | Tokyo | 103 0027 | Japan |
| Novartis Investigative Site | Chuo-ku | Tokyo | 103-0027 | Japan |
| Novartis Investigative Site | Toshima-ku | Tokyo | 171-0014 | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline of Pre-Dose Forced Expiratory Volume in 1 Second (FEV1) Measured After 26 And 52 Weeks Treatment | The pre-dose FEV1 was defined as the mean of the pre-dose 45 and 15 min FEV1 values prior to evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV1 indicates improvement in lung function. | Full Analysis Set (FAS) consisted of all participants who entered the treatment epoch of this study and received at least one dose of study medication during this study. Participants with a value at both baseline and the respective day are included. | Posted | Mean | Standard Deviation | liters (L) | Baseline, Weeks 26 and 52 |
|
|
|
| Secondary | Change From Baseline of Morning and Evening Peak Expiratory Flow (PEF) During 52 Weeks Treatment | PEF is the greatest airflow rate achieved during forced exhalation with lungs fully inflated. PEF was analyzed separately in the morning and evening using an electronic Peak Flow Meter (ePEF). A positive change from baseline in PEF indicates improvement in lung function. | FAS consisted of all participants who entered the treatment epoch of this study and received at least one dose of study medication during this study. Participants with a value at both baseline and the respective post baseline month are included. | Posted | Mean | Standard Deviation | liters/minute (L/min) | Baseline up to Week 52 |
|
|
|
| Secondary | Change From Baseline of Asthma Control Questionnaire (ACQ-7) After 26 And 52 Weeks Treatment | The ACQ-7 is a seven-item disease-specific instrument developed and validated to assess asthma control in participants. It consists of five items to assess symptoms and activity limitations, one question to assess rescue medication use, and one question to assess airway caliber (FEV1% predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question (question 7) was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function. | FAS consisted of all participants who entered the treatment epoch of this study and received at least one dose of study medication during this study. Participants with a value at both baseline and the respective day are included. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 26 and 52 |
|
|
|
| Secondary | Responder Rate of Participants Achieving the Minimal Important Difference (MID) of ACQ-7 ≥ 0.5 After 26 And 52 Weeks Treatment | The ACQ-7 is a seven-item disease-specific instrument developed and validated to assess asthma control in participants. It consists of five items to assess symptoms and activity limitations, one question to assess rescue medication use, and one question to assess airway caliber (FEV1% predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question (question 7) was completed by the study investigator using data from the Master Scope spirometer. The proportion of participants who achieved an improvement of at least 0.5 in ACQ-7 (i.e. decrease of ACQ-7 score of at least 0.5 from baseline) at post-baseline visits were analyzed. | FAS consisted of all participants who entered the treatment epoch of this study and received at least one dose of study medication during this study. Number analyzed indicates the number of participants with data available for analysis at Weeks 26 and 52. | Posted | Number | percentage of participants | Weeks 26 and 52 |
|
|
|
| Secondary | Change From Baseline of Rescue Medication Use During 52 Weeks Treatment | Based on the electronic-diary data, the total number of puffs of rescue medication per day over the 52 weeks were calculated and divided by the total number of days to derive the mean daily number of puffs of rescue medication taken for the participant. | FAS consisted of all participants who entered the treatment epoch of this study and received at least one dose of study medication during this study. Participants with a value at both baseline and the respective post baseline month are included. | Posted | Mean | Standard Deviation | puffs/day | Baseline up to Week 52 |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 37 |
| 51 |
| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Change at Week 52 |
|
|
| Title | Measurements |
|---|---|
|
| Change through Weeks 1-52, Evening PEF |
|
|
| Change at Week 52 |
|
|
|