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OpenTrials
Completed

NCT Number: NCT02566031

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

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

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Chuncheon, Gangwon-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

indacaterol and glycopyrronium (QVA149)

Drug

Capsules for inhalation delivered via SDDPI

Tiotropium

Drug

Capsules for inhalation delivered via HandiHaler® device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2015
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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