Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control

NCT ID: NCT01715311

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-09-30

Brief Summary

This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have not received maintenance COPD medication for at least 12 months prior to entry (described hereafter as "maintenance naïve", see inclusion criteria).

Detailed Description

The purpose is to provide efficacy data comparing the long-acting beta-2 agonist, indacaterol, with short-acting rescue therapy in maintenance-naive patients belonging to GOLD 2011 Groups A and B.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Indacaterol

Indacaterol once daily

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

Indacaterol once daily via single-dose dry powder inhaler

Placebo to indacaterol

Intervention Type: DRUG

Placebo to indacaterol capsules for inhalation once daily

Placebo

Placebo for indacaterol and placebo for tiotropium once daily

Group Type: PLACEBO_COMPARATOR

Placebo to tiotropium

Intervention Type: DRUG

Placebo to tiotropium capsules for inhalation once daily

Placebo to indacaterol

Intervention Type: DRUG

Placebo to indacaterol capsules for inhalation once daily

Tiotropium

Tiotropium

Group Type: ACTIVE_COMPARATOR

Placebo to tiotropium

Intervention Type: DRUG

Placebo to tiotropium capsules for inhalation once daily

Tiotropium

Intervention Type: DRUG

Tiotropium capsules for inhalation once daily

Interventions

Indacaterol

Indacaterol once daily via single-dose dry powder inhaler

Intervention Type: DRUG

Placebo to tiotropium

Placebo to tiotropium capsules for inhalation once daily

Intervention Type: DRUG

Tiotropium

Tiotropium capsules for inhalation once daily

Intervention Type: DRUG

Placebo to indacaterol

Placebo to indacaterol capsules for inhalation once daily

Intervention Type: DRUG

Other Intervention Names

Tiotropium 18 mcg od via single-dose dry powder inhaler

Eligibility Criteria

Inclusion Criteria

• Patients with stable Chronic Obstructive Pulmonary Disease (COPD) Groups A or B according to GOLD 2011.
• Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥50% and <80% of the predicted normal, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.7
• Patients with no record of receipt of maintenance medication for COPD.
• Patients with a mMRC dyspnea score ≥1 at Visit 2.
• Current or ex-smokers who have a smoking history of at least 10 pack years.

Exclusion Criteria

• Patients who have not achieved acceptable spirometry results at run-in, in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria for acceptability and repeatability.
• Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 12 months prior to Visit 1.
• Patients who have had a respiratory tract infection.
• Patients requiring long-term oxygen therapy (>12 hours a day) on a daily basis.
• Patients with a) any history of asthma, or b) onset of respiratory symptoms prior to age 40 years.
• Patients with allergic rhinitis who use a H1-antagonist or intra-nasal corticosteroids intermittently. Treatment with a stable dose is permitted.
• Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disorder, pulmonary hypertension) or active pulmonary tuberculosis

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

2012-001536-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAB149B2425

Identifier Type: -

Identifier Source: org_study_id