Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

Study Overview
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Brief Summary
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This study compared the efficacy of indacaterol versus placebo in COPD patients classified as GOLD 2014 Patient Group B. This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1 to receive prn salbutamol plus: Indacaterol 150ug or Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough FEV1) was assessed after 12 weeks.

Official Title
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Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Indacaterol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Male or female adults aged ≥40 years, who have provided their consent and signed an Informed Consent Form. Written informed consent must be obtained before any assessment is performed. Patients diagnosed with COPD at 40 years of age or older. Patients with smoking history of at least 10 pack years, both current and ex-smokers are eligible. (Ten pack years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc) Patients with stable COPD in Patient Group B according to GOLD 2014. Exclusion criteria Use of other investigational drugs within 5 half-lives of enrollment, or [within 30 days /until the expected PD effect has returned to baseline], whichever is longer. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or 1 or more exacerbation resulting in hospitalization in the 12 months prior to Visit 1. Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1. Patients who develop a moderate or severe COPD exacerbation during the period between Visit 1 and Visit 2. Patients with a history of asthma.

Ages Eligible for Study
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Minimum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>Matching placebo indacaterol capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) | Drug: Placebo<br>* Matching placebo indacaterol capsules for inhalation daily<br>|
| Experimental: Indacaterol 150 mcg<br>Indacaterol 150 mcg capsules for inhalation once daily delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) | Drug: Indacaterol<br>* Indacaterol 150µg capsules for inhalation daily<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) at 12 Weeks | To compare the effects of indacaterol 150ug once dialy (od) to placebo in GOLD 2014 Group B COPD patients, in terms of 24-hour postdose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of dosing. | at week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, FEV1, indacaterol