Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.
A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, Two-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients With Moderate to Severe Airflow Limitation.
1 other identifier
interventional
355
1 country
53
Brief Summary
The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 chronic-obstructive-pulmonary-disease
Started Jul 2015
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedStudy Start
First participant enrolled
July 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2016
CompletedResults Posted
Study results publicly available
April 2, 2018
CompletedApril 2, 2018
March 1, 2018
1.1 years
June 29, 2015
September 6, 2017
March 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.
baseline, 0 to 24 hours post-dose at week 12
Secondary Outcomes (8)
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
baseline, 0 to 24 hours post-dose at week 12
Superiority of QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)
baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12
Change From Baseline in FEV1 AUC 12-24h
baseline, 12 hours to 24 hours post-dose at week 12
Change From Baseline in FEV1 AUC 0-12h
baseline, 0 to 12 hours post-dose at week 12
Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
baseline, 12 weeks
- +3 more secondary outcomes
Study Arms (2)
QVA149
EXPERIMENTALQVA149 capsules for inhalation, delivered via QVA149 SDDPI
Umeclidinium/vilanterol
EXPERIMENTALUmeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Interventions
Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
Eligibility Criteria
You may qualify if:
- Male or female adults aged ≥40 yrs
- Smoking history of at least 10 pack years
- Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)
- Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)\< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
- Modified Medical Research Council questionnaire grade of 2 or higher
You may not qualify if:
- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular co-morbid conditions
- Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
- Patients in the active phase of a supervised pulmonary rehabilitation program
- Patients contraindicated for inhaled anticholinergic agents and β2 agonists
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Novartis Investigative Site
Anaheim, California, 92801, United States
Novartis Investigative Site
Escondido, California, 92025, United States
Novartis Investigative Site
Riverside, California, 92506, United States
Novartis Investigative Site
San Diego, California, 92103-8415, United States
Novartis Investigative Site
San Diego, California, 92117, United States
Novartis Investigative Site
San Diego, California, 92120, United States
Novartis Investigative Site
Chiefland, Florida, 32626, United States
Novartis Investigative Site
Clearwater, Florida, 33765, United States
Novartis Investigative Site
Gainesville, Florida, 32607, United States
Novartis Investigative Site
Miami, Florida, 33144, United States
Novartis Investigative Site
Miami, Florida, 33169, United States
Novartis Investigative Site
Winter Park, Florida, 32789, United States
Novartis Investigative Site
Florence, Kentucky, 41042, United States
Novartis Investigative Site
Owensboro, Kentucky, 42303, United States
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747, United States
Novartis Investigative Site
Livonia, Michigan, 48152, United States
Novartis Investigative Site
Saint Charles, Missouri, 63301, United States
Novartis Investigative Site
St Louis, Missouri, 63141, United States
Novartis Investigative Site
Lincoln, Nebraska, 68510, United States
Novartis Investigative Site
Omaha, Nebraska, 68134, United States
Novartis Investigative Site
Skillman, New Jersey, 08558, United States
Novartis Investigative Site
Gastonia, North Carolina, 28054, United States
Novartis Investigative Site
Monroe, North Carolina, 28112, United States
Novartis Investigative Site
New Bern, North Carolina, 28562, United States
Novartis Investigative Site
Raleigh, North Carolina, 27607, United States
Novartis Investigative Site
Shelby, North Carolina, 28150, United States
Novartis Investigative Site
Wilmington, North Carolina, 28401, United States
Novartis Investigative Site
Cincinnati, Ohio, 45231, United States
Novartis Investigative Site
Cincinnati, Ohio, 45245, United States
Novartis Investigative Site
Eugene, Oregon, 97404, United States
Novartis Investigative Site
Pottstown, Pennsylvania, 19464, United States
Novartis Investigative Site
Anderson, South Carolina, 29621, United States
Novartis Investigative Site
Charleston, South Carolina, 29406-7108, United States
Novartis Investigative Site
Charleston, South Carolina, 29407, United States
Novartis Investigative Site
Easley, South Carolina, 29640, United States
Novartis Investigative Site
Fort Mill, South Carolina, 29707, United States
Novartis Investigative Site
Gaffney, South Carolina, 29340, United States
Novartis Investigative Site
Greenville, South Carolina, 29615, United States
Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464, United States
Novartis Investigative Site
Rock Hill, South Carolina, 29732, United States
Novartis Investigative Site
Seneca, South Carolina, 29678, United States
Novartis Investigative Site
Simpsonville, South Carolina, 29681, United States
Novartis Investigative Site
Spartanburg, South Carolina, 29303, United States
Novartis Investigative Site
Union, South Carolina, 29379, United States
Novartis Investigative Site
Amarillo, Texas, 79106-4165, United States
Novartis Investigative Site
Boerne, Texas, 78006, United States
Novartis Investigative Site
El Paso, Texas, 79903, United States
Novartis Investigative Site
Fort Worth, Texas, 76104, United States
Novartis Investigative Site
Kingwood, Texas, 77339, United States
Novartis Investigative Site
Plano, Texas, 75093, United States
Novartis Investigative Site
San Antonio, Texas, 78299, United States
Novartis Investigative Site
Richmond, Virginia, 23225, United States
Novartis Investigative Site
Greenfield, Wisconsin, 53228, United States
Related Publications (1)
Kerwin E, Ferguson GT, Sanjar S, Goodin T, Yadao A, Fogel R, Maitra S, Sen B, Ayers T, Banerji D. Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies. Lung. 2017 Dec;195(6):739-747. doi: 10.1007/s00408-017-0055-9. Epub 2017 Oct 9.
PMID: 28993871DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2015
First Posted
July 1, 2015
Study Start
July 27, 2015
Primary Completion
September 6, 2016
Study Completion
September 6, 2016
Last Updated
April 2, 2018
Results First Posted
April 2, 2018
Record last verified: 2018-03