Exacerbation Study

Study Overview
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Brief Summary
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This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

Official Title
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A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Indacaterol 150 µg
* Drug: Tiotropium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including: Smoking history of at least 10 pack years, both current and ex-smokers are eligible A documented history of at least 1 moderate or severe exacerbation in the previous 12 months Exclusion Criteria: Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period Patients who have had a respiratory tract infection within 6 weeks prior to screening Patients with concomitant pulmonary disease Patients with a history of asthma 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 Other protocol-defined inclusion/exclusion criteria may apply

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indacaterol<br>Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI) | Drug: Indacaterol 150 µg<br>* Indacaterol 150 µg o.d. delivered via SDDPI<br>|
| Active Comparator: Tiotropium<br>Tiotropium 18 µg o.d. delivered via the handihaler® | Drug: Tiotropium<br>* Tiotropium 18 µg o.d. delivered via handihaler®<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). | The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of COPD Exacerbations | COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model. | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indacaterol, Tiotropium, COPD