Efficacy of Indacaterol 150 µg Versus Formoterol

April 19, 2017 updated by: Novartis Pharmaceuticals

A 12-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Parallel-group Study to Assess the Efficacy of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 μg b.i.d.) as an Active Control

The study will be a 12 week treatment (84 days), parallel group, randomized, double blind, double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1).

Patients will be enrolled after giving informed consent and then begin a screening/run-in period for 14 days. Patients will be randomized to one of two treatment groups using an allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of 12 weeks.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:

    • Post-bronchodilator FEV1 <80% and ≥40% of the predicted normal value
    • Post-bronchodilator FEV1/FVC (forced vital capacity) <70%
  • Smoking history of at least 10 pack-years

Exclusion Criteria:

  • Patients who have had a COPD exacerbation 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Indacaterol
Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)
Drug: Indacaterol
Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)
ACTIVE_COMPARATOR: Formoterol
Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)
Drug: Formoterol
Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24-h post-dose trough forced expiratory volume in 1 second (FEV1)
Time Frame: After 84 days of treatment
After 84 days of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
24-h post-dose trough inspiratory capacity (IC)
Time Frame: After 84 days of treatment
After 84 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ANTICIPATED)

February 1, 2012

Study Completion (ANTICIPATED)

February 1, 2012

Study Registration Dates

First Submitted

June 17, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (ESTIMATE)

June 21, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAB149BDE03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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