Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Five Different Doses of Inhaled Indacaterol (QAB149) Delivered Via the Single Dose Dry Powder Inhaler (SDDPI) in Patients With Persistent Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Indacaterol 27.5 mcg
* Drug: Indacaterol 37.5
* Drug: Indacaterol 55 mcg
* Drug: Indacaterol 75 mcg
* Drug: Indacaterol 150 mcg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthma for at least 6 months, using inhaled corticosteroid for at least one month, foreced breath test less than below the normal value of the general population, -show an immediate improvement in breathing when given albuterol Exclusion Criteria: patients who have smoked in the past 6 months or are currently smoking, including those who smoked more than a pack of cigarettes a day for at least 10 years, -patients who have a history of life-threatening asthma, -patients who have had an astham attack, in the last 6 weeks, requiring use of systemic steroids, hospitalization, or ER visit, -patients who have had a respiratory tract infection or worsening asthma between screening or run-in periods, patients requring use of other asthma-related drugs during the trial, other protocol-defined inclusion/exclusion may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Period Sequence 1<br>Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening | Drug: Indacaterol 27.5 mcg<br>* indacaterol 27.5 mcg twice daily inhaled once via inhaler<br>Drug: Placebo<br>* Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher<br>|
| Experimental: Treatment Period Sequence 2<br>Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening | Drug: Indacaterol 37.5<br>* Indacaterol 37.5 mcg once daily, inhaled once via inhaler<br>Drug: Placebo<br>* Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher<br>|
| Experimental: Treatment Period Sequence 3<br>Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening | Drug: Indacaterol 55 mcg<br>* Indacaterol 55 mcg once daily, inhaled once via inhaler<br>Drug: Placebo<br>* Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher<br>|
| Experimental: Treatment Sequence Period 4<br>Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening | Drug: Indacaterol 75 mcg<br>* Indacaterol 75 mcg once daily, inhaled once via inhaler<br>Drug: Placebo<br>* Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher<br>|
| Experimental: Treatment Period Sequence 5<br>Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening | Drug: Indacaterol 150 mcg<br>* Indacaterol 150 mcg once daily, inhaled once via inhaler<br>Drug: Placebo<br>* Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher<br>|
| Experimental: Treatment Period Sequence 6<br>Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening | Drug: Placebo<br>* Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Period Baseline in FEV1 (L) AUC(0-24h) | Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period. | Day 1 (24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h) | Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 12 hours post-dose period. | Day 1 (12 hours) | 
| Change From Period Baseline in Peak FEV1 (L) | Spirometry will be conducted according to internationally accepted standards. Peak Forced Expiratory Volume in 1 second (FEV1) is the maximum FEV1 recorded between different time points. | Day 1 (24 hours) | 
| Change From Period Baseline in Trough FEV1 (L) | Forced Expiratory Volume in 1 second (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. The trough in FEV1 is defined as the mean of two measurements at different time points. | Day 1 (24 hours) | 
| Change From Period Baseline in FVC (L) AUC (0-24h) | Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function. | Day 1 (24 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wheezing, short of breath, laba, inhaler