- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02487446
Efficacy and Safety Study of QVA149 in COPD Patients
A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, 2-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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Andalusia, Alabama, United States, 36305
- Novartis Investigative Site
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Anniston, Alabama, United States, 36207-5710
- Novartis Investigative Site
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Jasper, Alabama, United States, 35501
- Novartis Investigative Site
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Multiple Locations, Alabama, United States
- Novartis Investigative Site
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Arizona
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Multiple Locations, Arizona, United States
- Novartis Investigative Site
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Tempe, Arizona, United States, 85283
- Novartis Investigative Site
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Tucson, Arizona, United States, 85723
- Novartis Investigative Site
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Arkansas
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Fayetteville, Arkansas, United States, 72703
- Novartis Investigative Site
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California
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Huntington Beach, California, United States, 92647
- Novartis Investigative Site
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Rancho Mirage, California, United States, 92270
- Novartis Investigative Site
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Colorado
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Colorado Springs, Colorado, United States, 80907
- Novartis Investigative Site
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Florida
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Altamonte Springs, Florida, United States, 32701
- Novartis Investigative Site
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DeLand, Florida, United States, 32720
- Novartis Investigative Site
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Fort Lauderdale, Florida, United States, 33316-192
- Novartis Investigative Site
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Kissimmee, Florida, United States, 34741
- Novartis Investigative Site
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Miami, Florida, United States, 33172
- Novartis Investigative Site
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Pensacola, Florida, United States, 32503
- Novartis Investigative Site
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Pensacola, Florida, United States, 32504
- Novartis Investigative Site
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Port Orange, Florida, United States, 32127
- Novartis Investigative Site
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Georgia
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Conyers, Georgia, United States, 30094
- Novartis Investigative Site
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Duluth, Georgia, United States, 30096
- Novartis Investigative Site
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Idaho
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Meridian, Idaho, United States, 83642
- Novartis Investigative Site
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Louisiana
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New Orleans, Louisiana, United States, 70119
- Novartis Investigative Site
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Slidell, Louisiana, United States, 70458
- Novartis Investigative Site
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Sunset, Louisiana, United States, 70584
- Novartis Investigative Site
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Maryland
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Columbia, Maryland, United States, 21044
- Novartis Investigative Site
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Minnesota
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Edina, Minnesota, United States, 55435
- Novartis Investigative Site
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Fridley, Minnesota, United States, 55432
- Novartis Investigative Site
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Minneapolis, Minnesota, United States, 55402
- Novartis Investigative Site
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Minneapolis, Minnesota, United States, 55407
- Novartis Investigative Site
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Plymouth, Minnesota, United States, 55441
- Novartis Investigative Site
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Nevada
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Henderson, Nevada, United States, 89014
- Novartis Investigative Site
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New York
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New York, New York, United States, 10016
- Novartis Investigative Site
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Novartis Investigative Site
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Cornelius, North Carolina, United States, 28031
- Novartis Investigative Site
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Gastonia, North Carolina, United States, 28054
- Novartis Investigative Site
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Hickory, North Carolina, United States, 28602
- Novartis Investigative Site
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High Point, North Carolina, United States, 27262
- Novartis Investigative Site
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Huntersville, North Carolina, United States, 28078
- Novartis Investigative Site
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Winston-Salem, North Carolina, United States, 27103
- Novartis Investigative Site
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Ohio
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Cincinnati, Ohio, United States, 45242
- Novartis Investigative Site
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Columbus, Ohio, United States, 43215
- Novartis Investigative Site
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Columbus, Ohio, United States, 43213
- Novartis Investigative Site
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Dublin, Ohio, United States, 43016
- Novartis Investigative Site
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Marion, Ohio, United States, 43302
- Novartis Investigative Site
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Oregon
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Medford, Oregon, United States, 97504
- Novartis Investigative Site
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Portland, Oregon, United States, 97213
- Novartis Investigative Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19142
- Novartis Investigative Site
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Tipton, Pennsylvania, United States, 16684
- Novartis Investigative Site
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Texas
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Carrollton, Texas, United States, 75010
- Novartis Investigative Site
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Channelview, Texas, United States, 77530
- Novartis Investigative Site
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Fort Worth, Texas, United States, 76109
- Novartis Investigative Site
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Lampasas, Texas, United States, 76550
- Novartis Investigative Site
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McKinney, Texas, United States, 75069
- Novartis Investigative Site
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New Braunfels, Texas, United States, 78130
- Novartis Investigative Site
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Utah
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Salt Lake City, Utah, United States, 84102
- Novartis Investigative Site
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Virginia
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Newport News, Virginia, United States, 23606
- Novartis Investigative Site
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Washington
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Tacoma, Washington, United States, 98405
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: First QVA149, then Umeclidinium/vilanterol
Participants received QVA149 27.5/12.5
ug via inhalation twice daily (b.i.d.) for 12 weeks.
Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
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Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Other Names:
Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)
Other Names:
Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
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Experimental: First Umeclidinium/vilanterol, then QVA149
Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
Then after 3 weeks washout, participants received QVA149 27.5/12.5
ug via inhalation twice daily (b.i.d.) for 12 weeks.
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Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Other Names:
Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)
Other Names:
Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
Time Frame: baseline, 0 to 24 hours post-dose at week 12
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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.
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baseline, 0 to 24 hours post-dose at week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
Time Frame: baseline, 0 to 24 hours post-dose at week 12
|
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.
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baseline, 0 to 24 hours post-dose at week 12
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Change From Baseline in FEV1 AUC 12-24h
Time Frame: baseline, 12 hours to 24 hours post-dose at week 12
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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 12 hours (AUC 12-24h).
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baseline, 12 hours to 24 hours post-dose at week 12
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Change From Baseline in FEV1 AUC 0-12h
Time Frame: baseline, 0 to 12 hours post-dose at week 12
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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 12 hours (AUC 0-12h).
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baseline, 0 to 12 hours post-dose at week 12
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Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
Time Frame: baseline, 12 weeks
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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 4 hour intervals FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h.
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baseline, 12 weeks
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QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Time Frame: Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
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Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)
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Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)
Time Frame: baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose for each treatment
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baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12
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Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)
Time Frame: baseline, 15 minutes and 45 minutes pre morning dose at week 12
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
Pre-dose trough FEV1 was defined as the average of measurements made 15 minutes and 45 minutes pre morning dose for each treatment.
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baseline, 15 minutes and 45 minutes pre morning dose at week 12
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QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Time Frame: Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
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Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Adjuvants, Anesthesia
- Anticonvulsants
- Glycopyrrolate
- Bromides
Other Study ID Numbers
- CQVA149A2349
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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