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

A Randomized, Double-blind Placebo-controlled Study to Compare the Efficacy of Indacaterol With That of Placebo in Patients With COPD Who Have Not Previously Received Maintenance COPD Medication, Using Blinded Tiotropium as Active Control

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).

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Indacaterol; Drug: Placebo to indacaterol; Drug: Placebo to tiotropium; Drug: Tiotropium

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.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indacaterol; Indacaterol once daily	Drug: Indacaterol; Indacaterol once daily via single-dose dry powder inhaler; Drug: Placebo to indacaterol; Placebo to indacaterol capsules for inhalation once daily
Placebo Comparator: Placebo; Placebo for indacaterol and placebo for tiotropium once daily	Drug: Placebo to indacaterol; Placebo to indacaterol capsules for inhalation once daily; Drug: Placebo to tiotropium; Placebo to tiotropium capsules for inhalation once daily
Active Comparator: Tiotropium	Drug: Placebo to tiotropium; Placebo to tiotropium capsules for inhalation once daily; Drug: Tiotropium; Tiotropium capsules for inhalation once daily; Other Names: Tiotropium 18 mcg od via single-dose dry powder inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy comparison of indacaterol to placebo	Efficacy comparison of indacaterol to placebo (once daily treatment) by measuring Trough Forced Expiratory Volume in one second 24 hour postdose after 12 weeks of treatment.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
St George's Respiratory Questionnaire for COPD (SGRQ- C) total score comparison between treatments	Effects comparison of indacaterol to placebo in terms of the patient-centric measurement St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment.	12 weeks
Comparison of Forced Expiratory Volume in one second between indacaterol and tiotropium groups	Comparison of indacaterol to tiotropium using Trough Forced Expiratory Volume in one second.	12 weeks
St George's Respiratory Questionnaire for COPD total score comparison between treatments	Effects comparison of indacaterol to tiotropium in terms of St George's Respiratory Questionnaire for COPD (SGRQ- C) total score after 12 weeks of treatment.	12 weeks
Adverse events and serious adverse events for all treatment groups	All adverse events will be reported	week 12

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: COPD; Chronic obstructive pulmonary disease; indacaterol; tiotropium
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: CQAB149B2425; 2012-001536-59 (EudraCT Number)