Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks
Chronic Obstructive Pulmonary Disease
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Indacaterol
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:
- Smoking history of at least 10 pack-years
- Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced vital capacity) <70%
Exclusion Criteria:
- Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 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 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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigator Site
- Novartis Investigator Site
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- Novartis Investigator Site
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- Novartis Investigative Site
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- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
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- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigator Site
- Novartis Investigative Site
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- Novartis Investigative site
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- Novartis Investigative Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Indacaterol 75 µg
Placebo
Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.