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

Novartis Pharmaceuticals379 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

379

Conditions

COPD

Interventions

Indacaterol and glycopyrronium (QVA149)DRUG

Capsules for inhalation delivered via SDDPI

TiotropiumDRUG

Capsules for inhalation delivered via HandiHaler® device

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (24)

Novartis Investigative Site

Chuncheon, Gangwon-do, South Korea

Outcomes

Primary Outcomes

Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment

Spirometry was performed according to internationally accepted standards. Trough FEV1 is defined as the mean of 45 minute and 15 minute pre-dose values.

Time frame: Week 12

Secondary Outcomes

Trough Forced Expiratory Volume In One Second (FEV1) After 4 Weeks of Treatment

Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of 45 minute and 15 minute pre-dose values.

Time frame: mean of 45 min and 15 min pre-dose week 4

Baseline Transitional Dyspnea Index (TDI) Focal Score

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.

Time frame: Week 12

Number of Participants With Change From Baseline on Total Score of COPD Assessment Test (CAT)

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

Time frame: Week 12

Daily Rescue Medication Use (Number of Puffs)

Data from ClinicalTrials.gov

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