Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00570778
Last Updated: 2018-07-26
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
PHASE2
154 participants
INTERVENTIONAL
2007-12-31
2008-09-30
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.
A Study to Assess the Long-term Safety of QVA149
NCT01120717
A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
NCT01727141
Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
NCT00558285
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
Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients
NCT02442206
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
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
indacaterol/glycopyrrolate 300/50 μg
One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
indacaterol/glycopyrrolate
Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.
indacaterol 600 μg
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
indacaterol
Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
indacaterol 300 μg
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
indacaterol
Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
placebo
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
placebo
Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
indacaterol/glycopyrrolate
Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.
indacaterol
Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
placebo
Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
3. Patients who have smoking history of at least 10 pack years.
4. Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and \< 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) \<0.70.
Exclusion Criteria
2. Patients requiring long term oxygen therapy (\> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
3. Patients who have had a respiratory tract infection within 6 weeks prior to screening.
4. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
5. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 400/mm3.
6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
7. Patients with uncontrolled Type I and Type II diabetes.
8. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
9. Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
10. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (\>450 ms for males or \>470 ms for females).
11. Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.
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.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigator Site
St Louis, Missouri, United States
Novartis Investigator Site
Charlotte, North Carolina, United States
Novartis Investigator site
Raleigh, North Carolina, United States
Novartis Investigator Site
Antwerp, , Belgium
Novartis Investigator Site
Ghent, , Belgium
Novartis Investigator Site
Jambes, , Belgium
Novartis Investigator Site
Sankt Vith, , Belgium
Novartis Investigator Site
Moncton, , Canada
Novartis Investigator Site
Montreal, , Canada
Novartis Investigator site
Toronto, , Canada
Novartis Investigator Site
Bad Wörishofen, , Germany
Novartis Investigator Site
Berlin, , Germany
Novartis Investigator Site
Frankfurt, , Germany
Novartis Investigator Site
Mainz, , Germany
Novartis Investigator Site
Rudersdorf, , Germany
Novartis Investigator Site
Wiesbaden, , Germany
Novartis Investigator Site
Almelo, , Netherlands
Novartis Investigator Site
Breda, , Netherlands
Novartis Investigator site
Eindhoven, , Netherlands
Novartis investigator site
Heerlen, , Netherlands
Novartis Investigator Site
Nijmegen, , Netherlands
Novartis Investigator Site
Veldhoven, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
van Noord JA, Buhl R, Laforce C, Martin C, Jones F, Dolker M, Overend T. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax. 2010 Dec;65(12):1086-91. doi: 10.1136/thx.2010.139113. Epub 2010 Oct 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CQVA149A2204
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.