Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)

July 22, 2011 updated by: Novartis

A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 µg o.d. Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 µg b.i.d. as Active Control

This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second [FEV1]) over the full 24-h time period

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Beuvry, France
        • Novartis Investigative Site
      • Nantes, France
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Mainz, Germany
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site

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:

  • Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
  • Co-operative outpatients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
  • Smoking history of at least 20 pack years
  • Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value
  • Post-bronchodilator FEV1/forced vital capacity (FVC) < 70%

Exclusion criteria:

  • Pregnant or lactating females
  • Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
  • Patients requiring long term oxygen therapy (>15 h a day)
  • Patient who have had a respiratory tract infection 6 weeks prior to V2 (with further criteria)
  • Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
  • Patients with history of asthma (with further criteria)
  • Patients with Type I or uncontrolled type II diabetes.
  • Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
  • Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
  • Patient with a history with long QT syndrome or whose QTc interval is prolonged
  • Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structure
  • Patients who have had treatment with an investigational drug (with further criteria)
  • Patients who have had live attenuated vaccination within 30 days prior to Visit 2, or during run-in period
  • Patients with known history of non compliance to medication
  • Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indacaterol Morning,Indacaterol Evening, Salmeterol
In period I, indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, Salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and second dose in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Names:
  • Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
Experimental: Indacaterol Evening,Indacaterol Morning, Placebo
In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
Experimental: Salmeterol, Placebo, Indacaterol Morning
In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Names:
  • Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
Experimental: Placebo, Salmeterol, Indacaterol Evening
In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Names:
  • Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
Experimental: Indacaterol Morning, Placebo, Indacaterol Evening
In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
Experimental: Indacaterol Evening,Salmeterol, Indacaterol Morning
In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Names:
  • Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
Experimental: Salmeterol, Indacaterol Evening, Placebo
In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Names:
  • Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
Experimental: Placebo, Indacaterol Morning, Salmeterol
In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via dry powder inhaler DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Names:
  • Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
Experimental: Indacaterol Morning, Salmeterol, Placebo
In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Names:
  • Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
Experimental: Indacaterol Evening, Placebo, Salmeterol
In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry powder inhaler DPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Names:
  • Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
Experimental: Salmeterol, Indacaterol Morning, Indacaterol Evening
In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Salmeterol
50 µg twice daily delivered via dry powder inhaler (DPI)
Other Names:
  • Serevent®
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI
Experimental: Placebo, Indacaterol Evening, Indacaterol Morning
In period, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Drug: Indacaterol
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Other Names:
  • QAB149
Drug: Placebo to Indacaterol
Placebo matching indacaterol was delivered via SDDPI.
Drug: Placebo to Salmeterol
Placebo matching salmeterol was delivered via DPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo
Time Frame: After 14 days of treatment

Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 10 min and 23h 45 min post dose. The primary variable was analyzed using an analysis of covariance (ANCOVA) model with the (period) baseline FEV1 as covariate.

The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.
After 14 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons
Time Frame: After 14 days of dosing
Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. On the morning and evening of Day 15 trough FEV1 (i.e. mean of measurements performed 23 h 10 min and 23 h 45 min post-dose) were assessed. An analysis of covariance (ANCOVA) model was used with the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.
After 14 days of dosing

Collaborators and Investigators

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

Sponsor

Novartis

Investigators

  • Principal Investigator: Novartis Pharmaceuticals, + 41 61 324 1111

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

August 17, 2011

Last Update Submitted That Met QC Criteria

July 22, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAB149B2305

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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