A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients

August 21, 2019 updated by: Novartis Pharmaceuticals
To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15 min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

379

Phase

  • Phase 4

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

  • Korea, Republic of
      • Gwangju, Korea, Republic of, 61469
        • Novartis Investigative Site
      • Incheon, Korea, Republic of, 405 760
        • Novartis Investigative Site
      • Incheon, Korea, Republic of, 403-720
        • Novartis Investigative Site
      • Jeju, Korea, Republic of, 63241
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 03722
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 150-713
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 04763
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 05030
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 156-707
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 110-746
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 06273
        • Novartis Investigative Site
      • Ulsan, Korea, Republic of, 44033
        • Novartis Investigative Site
    • Gangwon-Do
      • Wonju, Gangwon-Do, Korea, Republic of, 26426
        • Novartis Investigative Site
    • Gangwon-do
      • Chuncheon, Gangwon-do, Korea, Republic of, 24253
        • Novartis Investigative Site
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
        • Novartis Investigative Site
      • Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
        • Novartis Investigative Site
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
        • Novartis Investigative Site
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
        • Novartis Investigative Site
    • Jeollabuk-do
      • Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 06351
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 08308
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 03312
        • Novartis Investigative Site
    • Kyunggi
      • Koyang, Kyunggi, Korea, Republic of, 410-719
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul, Seocho Gu, Korea, Republic of, 06591
        • 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:

  • Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 50% of the predicted normal value and post-bronchodilator FEV1/FVC < 0.7 (COPD Grade 1 or 2 by severity of airflow limitation (GOLD 2015)
  • Patients with CAT score ≥ 10 at Visit 0 and Visit 1.
  • Patients who are on and have been on tiotropium monotherapy for the past 3 months.
  • 0 or 1 COPD exacerbation in the previous 12 months (not leading to hospital admission).

Exclusion Criteria:

  • Treatment with any inhaled corticosteroid (ICS) in the 3 months prior to Visit 1.
  • COPD exacerbation between Visit 0 and 1.
  • Patients with concomitant pulmonary disease
  • Patients with a history of respiratory infection within 4 weeks prior to Visit 0.
  • Prior or current diagnosis of asthma.
  • Presence of any contraindication, warning, precaution, hypersensitivity to LABA and LAMA

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indacaterol and glycopyrronium (QVA149)
QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks
Drug: Indacaterol and glycopyrronium (QVA149)
Capsules for inhalation delivered via SDDPI
Active Comparator: Tiotropium
Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks
Drug: Tiotropium
Capsules for inhalation delivered via HandiHaler® device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment
Time Frame: Week 12
Spirometry was performed according to internationally accepted standards. Trough FEV1 is defined as the mean of 45 minute and 15 minute pre-dose values.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume In One Second (FEV1) After 4 Weeks of Treatment
Time Frame: mean of 45 min and 15 min pre-dose week 4
Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of 45 minute and 15 minute pre-dose values.
mean of 45 min and 15 min pre-dose week 4
Baseline Transitional Dyspnea Index (TDI) Focal Score
Time Frame: Week 12
A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. TDI captures changes from baseline, each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.
Week 12
Number of Participants With Change From Baseline on Total Score of COPD Assessment Test (CAT)
Time Frame: Week 12
Total score of COPD Assessment Test (CAT) will be measured at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. Mild: Score = 0 - 10, Moderate: Score = 11 - 20, Severe: Score = 21 - 30, Very Severe: Score = 31 - 40. The CAT total score was the sum of 8 item scores (each ranging from 0 to 5). If 1 or 2 items were missing, they were replaced with the mean of the completed items. If 3 or more items were missing, the CAT total score was set missing
Week 12
Daily Rescue Medication Use (Number of Puffs)
Time Frame: Week 12
The total number of puffs of rescue medication used over the last 24 hours will be recorded in the patient diary in the morning. The total number of puffs of rescue medication per day over the full 12 weeks will be calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient. The mean daily number of puffs of rescue medication used over 12 weeks will be summarized by treatments
Week 12

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 (Actual)

March 23, 2013

Primary Completion (Actual)

June 4, 2018

Study Completion (Actual)

June 4, 2018

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQVA149AKR01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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