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

NCT02566031 | Completed Phase 4 Results

• 1 other identifier: CQVA149AKR01
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 24

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

Conditions

COPD

Keywords

COPD; open-label; QVA149; symptomatic; tiotropium

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (4)

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

  mean of 45 min and 15 min pre-dose week 4

• Baseline Transitional Dyspnea Index (TDI) Focal Score

  Week 12

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

  Week 12

• Daily Rescue Medication Use (Number of Puffs)

  Week 12

Study Arms (2)

Indacaterol and glycopyrronium (QVA149)

EXPERIMENTAL

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)

Tiotropium

ACTIVE COMPARATOR

Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks

Drug: Tiotropium

Interventions

Indacaterol and glycopyrronium (QVA149) DRUG

Capsules for inhalation delivered via SDDPI

Indacaterol and glycopyrronium (QVA149)

Tiotropium DRUG

Capsules for inhalation delivered via HandiHaler® device

Tiotropium

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• or 1 COPD exacerbation in the previous 12 months (not leading to hospital admission).

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (24)

Novartis Investigative Site

Chuncheon, Gangwon-do, 24253, South Korea

Location

Novartis Investigative Site

Wŏnju, Gangwon-do, 26426, South Korea

Location

Novartis Investigative Site

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Novartis Investigative Site

Guri-si, Gyeonggi-do, 471-701, South Korea

Location

Novartis Investigative Site

Seongnam-si, Gyeonggi-do, 463-712, South Korea

Location

Novartis Investigative Site

Suwon, Gyeonggi-do, 16499, South Korea

Location

Novartis Investigative Site

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 03312, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 06351, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 08308, South Korea

Location

Novartis Investigative Site

Koyang, Kyunggi, 410-719, South Korea

Location

Novartis Investigative Site

Seoul, Seocho Gu, 06591, South Korea

Location

Novartis Investigative Site

Gwangju, 61469, South Korea

Location

Novartis Investigative Site

Incheon, 403-720, South Korea

Location

Novartis Investigative Site

Incheon, 405 760, South Korea

Location

Novartis Investigative Site

Jeju City, 63241, South Korea

Location

Novartis Investigative Site

Seoul, 03722, South Korea

Location

Novartis Investigative Site

Seoul, 04763, South Korea

Location

Novartis Investigative Site

Seoul, 05030, South Korea

Location

Novartis Investigative Site

Seoul, 06273, South Korea

Location

Novartis Investigative Site

Seoul, 110-746, South Korea

Location

Novartis Investigative Site

Seoul, 150-713, South Korea

Location

Novartis Investigative Site

Seoul, 156-707, South Korea

Location

Novartis Investigative Site

Ulsan, 44033, South Korea

Location

Related Publications (1)

• 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.

  PMID: 28228162 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Glycopyrrolate; indacaterol-glycopyrronium combination; Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

8627788300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: October 1, 2015
• Study Start: March 23, 2013
• Primary Completion: June 4, 2018
• Study Completion: June 4, 2018
• Last Updated: September 23, 2019
• Results First Posted: September 23, 2019

Record last verified: 2019-08

Locations

KR (24)