Efficacy and Safety of Different Doses of Indacaterol

Study Overview
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Brief Summary
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This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol

Official Title
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A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Adult Patients With Persistent Asthma, Using Salmeterol as an Active Control

Conditions
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Asthma

Intervention / Treatment
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* Drug: Indacaterol
* Drug: Salmeterol
* Drug: Placebo to Indacaterol
* Drug: Placebo to Salmeterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of asthma, and: Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening Prebronchodilator forced expiratory volume in 1 second (FEV1) at screening ≥50 and ≤90% of predicted normal An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling albuterol Exclusion Criteria: Smoking history >10 pack-years Patients with a diagnosis of chronic obstructive pulmonary disease (COPD) Patients with seasonal allergy whose asthma is likely to deteriorate during the study period Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening Patients who have had an intubation for a severe asthma exacerbation Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to screening Patients who have had a respiratory tract infection within 6 weeks prior to screening Patients with concomitant pulmonary disease Patients with diabetes Type I or uncontrolled diabetes Type II Any patient with lung cancer or a history of lung cancer Patients with a history of certain cardiovascular comorbid conditions Patients who have ever received or are currently receiving omalizumab or chronic oral corticosteroid therapy Other protocol-defined inclusion/exclusion criteria 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indacaterol 18.75 µg<br>Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. | Drug: Indacaterol<br>* Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.<br>Drug: Placebo to Salmeterol<br>* Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).<br>|
| Experimental: Indacaterol 37.5 µg<br>Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. | Drug: Indacaterol<br>* Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.<br>Drug: Placebo to Salmeterol<br>* Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).<br>|
| Experimental: Indacaterol 75 µg<br>Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. | Drug: Indacaterol<br>* Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.<br>Drug: Placebo to Salmeterol<br>* Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).<br>|
| Experimental: Indacaterol 150 µg<br>Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. | Drug: Indacaterol<br>* Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.<br>Drug: Placebo to Salmeterol<br>* Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).<br>|
| Active Comparator: Salmeterol<br>Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. | Drug: Salmeterol<br>* 50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.<br>Drug: Placebo to Indacaterol<br>* Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.<br>|
| Placebo Comparator: Placebo<br>Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study. | Drug: Placebo to Indacaterol<br>* Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.<br>Drug: Placebo to Salmeterol<br>* Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment | Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates. | Day 15 (after 2 weeks of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment | Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates. | Day 2 (after 1 day of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indacaterol, asthma, salmeterol