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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— INITIATE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01715311
• Other study ID #: CQAB149B2425
• Secondary ID: 2012-001536-59
• Status: Withdrawn
• Phase: Phase 4
• First received: October 24, 2012
• Last updated: April 19, 2017
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol
Indacaterol once daily via single-dose dry powder inhaler
• Placebo to tiotropium
Placebo to tiotropium capsules for inhalation once daily
• Tiotropium
Tiotropium capsules for inhalation once daily
• Placebo to indacaterol
Placebo to indacaterol capsules for inhalation once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Adverse events and serious adverse events for all treatment groups	All adverse events will be reported	week 12