Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

June 28, 2018 updated by: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 2

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

  • Belgium
      • Antwerpen, Belgium
        • Novartis Investigator Site
      • Gent, Belgium
        • Novartis Investigator Site
      • Jambes, Belgium
        • Novartis Investigator Site
      • Saint Vith, Belgium
        • Novartis Investigator Site
  • Canada
      • Moncton, Canada
        • Novartis Investigator Site
      • Montreal, Canada
        • Novartis Investigator Site
      • Toronto, Canada
        • Novartis Investigator Site
  • Germany
      • Bad Worishofen, Germany
        • Novartis Investigator Site
      • Berlin, Germany
        • Novartis Investigator Site
      • Frankfurt, Germany
        • Novartis Investigator Site
      • Mainz, Germany
        • Novartis Investigator Site
      • Rudersdorf, Germany
        • Novartis Investigator Site
      • Wiesbaden, Germany
        • Novartis Investigator Site
  • Netherlands
      • Almelo, Netherlands
        • Novartis Investigator Site
      • Breda, Netherlands
        • Novartis Investigator Site
      • Eindhoven, Netherlands
        • Novartis Investigator Site
      • Heerlen, Netherlands
        • Novartis Investigator Site
      • Nijmegen, Netherlands
        • Novartis Investigator Site
      • Veldhoven, Netherlands
        • Novartis Investigator Site
  • United States
    • Missouri
      • Saint Louis, Missouri, United States
        • Novartis Investigator Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Novartis Investigator Site
      • Raleigh, North Carolina, United States
        • Novartis Investigator 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:

  1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
  2. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
  3. Patients who have smoking history of at least 10 pack years.
  4. Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.

Exclusion Criteria:

  1. Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
  2. Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
  3. Patients who have had a respiratory tract infection within 6 weeks prior to screening.
  4. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
  5. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
  6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
  7. Patients with uncontrolled Type I and Type II diabetes.
  8. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
  9. Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
  10. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
  11. Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: indacaterol/glycopyrrolate 300/50 μg
One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
Drug: indacaterol/glycopyrrolate
Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.
Other Names:
  • QVA149
Active Comparator: indacaterol 600 μg
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Drug: indacaterol
Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Other Names:
  • QAB149
Active Comparator: indacaterol 300 μg
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
Drug: indacaterol
Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Other Names:
  • QAB149
Placebo Comparator: placebo
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Drug: placebo
Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
Time Frame: Baseline, Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.
Baseline, Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7
Time Frame: Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.
Day 7
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Time Frame: 47 days
Additional information about adverse events can be found in the Adverse Event Section.
47 days

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

December 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

June 28, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQVA149A2204

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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