Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo to indacaterol; Drug: Indacaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01068600

CQAB149B2355

Details and patient eligibility

About

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

Enrollment: 318 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

  1. Smoking history of at least 10 pack-years
  2. Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
  3. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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318 participants in 2 patient groups, including a placebo group

Indacaterol 75 µg

Experimental group

Description:

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.

Treatment:

Drug: Indacaterol

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo to indacaterol