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

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo to Salmeterol; Drug: Placebo to Indacaterol; Drug: Indacaterol 150 μg; Drug: Salmeterol 50 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567996

CQAB149B2336

Details and patient eligibility

About

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

Enrollment: 1,002 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,002 participants in 3 patient groups, including a placebo group

Indacaterol 150 μg

Experimental group

Description:

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.

Treatment:

Drug: Placebo to Salmeterol

Drug: Indacaterol 150 μg

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo to Salmeterol

Drug: Placebo to Indacaterol

Salmeterol 50 μg

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo to Indacaterol

Drug: Salmeterol 50 μg