Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Keywords: COPD
open-label
QVA149
symptomatic
tiotropium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 379
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment
timeFrame: Week 12
Secondary outcomes:
measure: Trough Forced Expiratory Volume In One Second (FEV1) After 4 Weeks of Treatment
timeFrame: mean of 45 min and 15 min pre-dose week 4
measure: Baseline Transitional Dyspnea Index (TDI) Focal Score
timeFrame: Week 12
measure: Number of Participants With Change From Baseline on Total Score of COPD Assessment Test (CAT)
timeFrame: Week 12
measure: Daily Rescue Medication Use (Number of Puffs)
timeFrame: Week 12
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon-do
city: Wonju
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon-Do
city: Anyang-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Guri-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Jeonju-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Jeollabuk-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Koyang
country: Korea, Republic of
facility: Novartis Investigative Site
state: Kyunggi
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seocho Gu
city: Gwangju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Jeju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Ulsan
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
References:
citation: Rhee CK, Park HY, Park JW, Lee JH, Kim TH, Lee SW, Jung JY, Kim S, Hwang YI, Jung KS. Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial. Trials. 2017 Feb 22;18(1):80. doi: 10.1186/s13063-017-1800-3.