Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Indacaterol, COPD, salmeterol
Eligibility Criteria
Inclusion criteria:
Diagnosis of chronic obstructive pulmonary disease (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 forced expiratory volume in 1 second (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 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 applied to the study.
Sites / Locations
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
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- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigative Site
- Novartis Investigative site
- Novartis Investigative Site
- Novartis Investigator Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Indacaterol 18.75 μg
Indacaterol 37.5 μg
Indacaterol 75 μg
Indacaterol 150 μg
Salmeterol 50 μg
Placebo
Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.