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

Novartis

Status and phase: Withdrawn; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Indacaterol; Drug: Placebo to tiotropium; Drug: Tiotropium; Drug: Placebo to indacaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01715311

CQAB149B2425

2012-001536-59 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 3 patient groups, including a placebo group

Indacaterol

Experimental group

Description:

Indacaterol once daily

Treatment:

Drug: Placebo to indacaterol

Drug: Indacaterol

Placebo

Placebo Comparator group

Description:

Placebo for indacaterol and placebo for tiotropium once daily

Treatment:

Drug: Placebo to indacaterol

Drug: Placebo to tiotropium

Tiotropium

Active Comparator group

Description:

Tiotropium

Treatment:

Drug: Tiotropium

Drug: Placebo to tiotropium