A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
NCT ID: NCT01682863
Last Updated: 2016-03-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
614 participants
INTERVENTIONAL
2012-10-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long Term Safety Study of NVA237 vs QAB149 in COPD Patients
NCT01697696
Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01529632
QVA Mechanistic Efficacy Study (Receptor Effects, Etc)
NCT02634983
The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01574651
A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01202188
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
QVA149 dose 1
QVA149 27.5/12.5 μg capsules
QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
QVA149 dose 2
QVA149 27.5/25 μg capsules
QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
QAB149
QAB149 75 μg capsules
QAB149
QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI
Placebo
To mimic QAB149
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
QAB149
QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI
Placebo
To mimic QAB149
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with stable COPD according to GOLD strategy (GOLD 2011).
* Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and \<80% of the predicted normal, and a post-bronchodilator FEV1/FVC \< 0.70.
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Patients with an mMRC ≥ grade 2
Exclusion Criteria
* Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
* Patients with Type I or uncontrolled Type II diabetes
* Patients with a history of asthma or have concomitant pulmonary disease
* Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible
* Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Vestavia Hills, Alabama, United States
Novartis Investigative Site
Huntington Beach, California, United States
Novartis Investigative Site
Lakewood, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Orange, California, United States
Novartis Investigative Site
Stockton, California, United States
Novartis Investigative Site
Walnut Creek, California, United States
Novartis Investigative Site
Boulder, Colorado, United States
Novartis Investigative Site
Honolulu, Hawaii, United States
Novartis Investigative Site
Lombard, Illinois, United States
Novartis Investigative Site
O'Fallon, Illinois, United States
Novartis Investigative Site
Peoria, Illinois, United States
Novartis Investigative Site
Evansville, Indiana, United States
Novartis Investigative Site
Ames, Iowa, United States
Novartis Investigative Site
Iowa City, Iowa, United States
Novartis Investigative Site
Waterloo, Iowa, United States
Novartis Investigative Site
Bowling Green, Kentucky, United States
Novartis Investigative Site
New Orleans, Louisiana, United States
Novartis Investigative Site
Slidell, Louisiana, United States
Novartis Investigative Site
Bangor, Maine, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Livonia, Michigan, United States
Novartis Investigative Site
Minneapolis, Minnesota, United States
Novartis Investigative Site
Jackson, Mississippi, United States
Novartis Investigative Site
Picayune, Mississippi, United States
Novartis Investigative Site
Saint Charles, Missouri, United States
Novartis Investigative Site
Missoula, Montana, United States
Novartis Investigative Site
Lincoln, Nebraska, United States
Novartis Investigative Site
Omaha, Nebraska, United States
Novartis Investigative Site
Henderson, Nevada, United States
Novartis Investigative Site
Las Vegas, Nevada, United States
Novartis Investigative Site
Rochester, New York, United States
Novartis Investigative Site
Dayton, Ohio, United States
Novartis Investigative Site
Dublin, Ohio, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Eugene, Oregon, United States
Novartis Investigative Site
Medford, Oregon, United States
Novartis Investigative Site
Spartanburg, South Carolina, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Novartis Investigative Site
Corsicana, Texas, United States
Novartis Investigative Site
Fort Worth, Texas, United States
Novartis Investigative Site
Lufkin, Texas, United States
Novartis Investigative Site
McKinney, Texas, United States
Novartis Investigative Site
Abingdon, Virginia, United States
Novartis Investigative Site
Midlothian, Virginia, United States
Novartis Investigative Site
Newport News, Virginia, United States
Novartis Investigative Site
Rousse, Bulgaria, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria, Bulgaria
Novartis Investigative Site
Varna, Bulgaria, Bulgaria
Novartis Investigative Site
Pleven, , Bulgaria
Novartis Investigative Site
Plovdiv, , Bulgaria
Novartis Investigative Site
Helsinki, Finland, Finland
Novartis Investigative Site
HUS, , Finland
Novartis Investigative Site
Pori, , Finland
Novartis Investigative Site
Turku, , Finland
Novartis Investigative Site
Nyíregyháza, Hungary, Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Győr, , Hungary
Novartis Investigative Site
Makó, , Hungary
Novartis Investigative Site
Pécs, , Hungary
Novartis Investigative Site
Százhalombatta, , Hungary
Novartis Investigative Site
Szolnok, , Hungary
Novartis Investigative Site
Törökbálint, , Hungary
Novartis Investigative Site
Barceloneta, , Puerto Rico
Novartis Investigative Site
San Juan, , Puerto Rico
Novartis Investigative Site
San Juan, , Puerto Rico
Novartis Investigative Site
Bucharest, District 1, Romania
Novartis Investigative Site
Bucharest, District 1, Romania
Novartis Investigative Site
Bucharest, District 3, Romania
Novartis Investigative Site
Bucharest, District 3, Romania
Novartis Investigative Site
Constanța, Jud. Constanta, Romania
Novartis Investigative Site
Iași, Jud. Iasi, Romania
Novartis Investigative Site
Brasov, Romania, Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Cluj-Napoca, , Romania
Novartis Investigative Site
Granada, Andalusia, Spain
Novartis Investigative Site
Málaga, Andalusia, Spain
Novartis Investigative Site
Badalona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Canet de Mar, Catalonia, Spain
Novartis Investigative Site
Centelles, Catalonia, Spain
Novartis Investigative Site
Tarragona, Catalonia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-001998-93
Identifier Type: -
Identifier Source: secondary_id
CQVA149A2340
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.