Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

Official Title: “A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control”

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Intervention(s) in this Clinical Trial

• Drug: Indacaterol 150 μg
  • Indacaterol 150 μg once daily (o.d) inhaled
• Drug: Salmeterol 50 μg
  • Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler
• Drug: Placebo to Indacaterol
  • Placebo to Indacaterol inhaled via SDDPI.
• Drug: Placebo to Salmeterol
  • Placebo to salmeterol delivered via a proprietary dry powder inhaler

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Indacaterol 150 μg
  • Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
• Placebo Comparator: Placebo
  • Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
• Active Comparator: Salmeterol 50 μg
  • Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Primary Measures

• Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
  • Time Frame: Week 12
    Safety Issue?: No

Secondary Measures

• St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
  • Time Frame: Week 12
    Safety Issue?: No
• Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment
  • Time Frame: Up to 26 weeks
    Safety Issue?: No

Inclusion Criteria:

• Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:
• Smoking history of at least 20 pack years
• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% predicted and >or= 30% of predicted normal value
• Post-bronchodilator FEV1/FVC < 70%
• ("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

Exclusion Criteria:

• Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
• Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in
• Patients requiring oxygen therapy for chronic hypoxemia (typically >15h/day)
• Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
• Concomitant pulmonary disease
• Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
• History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for females
• Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
• History of reactions to sympathomimetic amines or inhaled medication
• Inability to use the dry powder devices or perform spirometry
• Irregular day/night, wake/sleep cycles, e.g. shift workers
• Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period
• Patients unable or unwilling to complete a patient diary
• Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharma AG Study Chair Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00567996

Study ID Number: CQAB149B2336

ClinicalTrials.gov Identifier: NCT00567996

Health Authority: Brazil: Ministry of Health