Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01119950
Last Updated: 2015-03-23
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
388 participants
INTERVENTIONAL
2010-04-30
2010-12-31
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.
Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01154127
A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00856193
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
NCT01005901
Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT00510510
Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium
NCT00501852
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
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NVA237 12.5 µg q.d.
NVA237 12.5 µg once daily
NVA237 12.5 µg once daily
NVA237 12.5 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
NVA237 25.0 µg q.d.
NVA237 25.0 µg once daily
NVA237 25.0 µg once daily
NVA237 25.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
NVA237 12.5 µg b.i.d.
NVA237 12.5 µg twice daily
NVA237 12.5 µg twice daily
NVA237 12.5 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.
NVA237 50.0 µg q.d.
NVA237 50.0 µg once daily
NVA237 50.0 µg once daily
NVA237 50.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
NVA237 25.0 µg b.i.d.
NVA237 25.0 µg twice daily
NVA237 25.0 µg twice daily
NVA237 25.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.
NVA237 100.0 µg q.d.
NVA237 100.0 µg once daily
NVA237 100.0 µg once daily
NVA237 100.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
NVA237 50.0 µg b.i.d.
NVA237 50.0 µg twice daily
NVA237 50.0 µg twice daily
NVA237 50.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.
Placebo
Placebo to NVA237 once daily
Placebo to NVA237 once daily
Placebo to NVA237 via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NVA237 12.5 µg once daily
NVA237 12.5 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
NVA237 25.0 µg once daily
NVA237 25.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
NVA237 12.5 µg twice daily
NVA237 12.5 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.
NVA237 50.0 µg once daily
NVA237 50.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
NVA237 25.0 µg twice daily
NVA237 25.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.
NVA237 100.0 µg once daily
NVA237 100.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
NVA237 50.0 µg twice daily
NVA237 50.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.
Placebo to NVA237 once daily
Placebo to NVA237 via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of Chronic Obstructive Lung Disease (COPD) (moderate to severe as classified by the Global Initiative for COPD (GOLD) Guidelines, 2008
* Smoking history of at least 10 pack-years
* Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) \<80% and ≥30% of the predicted normal value
* Post-bronchodilator FEV1/Forced Vital Capacity (FVC) \<0.7
* Symptomatic patients, according to daily electronic diary data between visit 2 (Day -8) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to visit 3
Exclusion Criteria
* Patients who have had a respiratory tract infection within 4 weeks prior to the first visit
* Patients with concomitant pulmonary disease
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular co-morbid conditions
* Patients with a history of asthma or a blood eosinophil count \>600/mm3 or onset of symptoms prior to 40 years
* Patients with eczema, known high IgE levels or a known positive skin prick test
* Patients participating in the active phase of a pulmonary rehabilitation programme
* Patients contraindicated for the treatment with anticholinergics, long and short-acting beta-2 agonists or sympathomimetic amines
* Patients with a history of alpha-1 anti-trypsin deficiency
* Patients on long term oxygen therapy (\>15hr per day)
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_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Almelo, , Netherlands
Novartis Investigative Site
Eindhoven, , Netherlands
Novartis Investigative Site
Harderwijk, , Netherlands
Novartis Investigative Site
Heerlen, , Netherlands
Novartis Investigative Site
Helmond, , Netherlands
Novartis Investigative Site
Veldhoven, , Netherlands
Novartis Investigative Site
Zutphen, , Netherlands
Novartis Investigative Site
Anniston, Alabama, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Torrance, California, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
Omaha, Nebraska, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Antwerp, , Belgium
Novartis Investigative Site
Genk, , Belgium
Novartis Investigative site
Jambes, , Belgium
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Balassagyarmat, , Hungary
Novartis Investigative Site
Balatonfüred, , Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Szolnok, , Hungary
Novartis Investigative Site
Törökbálint, , Hungary
Novartis Investigative Site
Izabelin, , Poland
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
A Coruña, , Spain
Novartis Investigative Site
Alicante, , Spain
Novartis Investigative Site
Ponferrada, , Spain
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.
Arievich H, Overend T, Renard D, Gibbs M, Alagappan V, Looby M, Banerji D. A novel model-based approach for dose determination of glycopyrronium bromide in COPD. BMC Pulm Med. 2012 Dec 8;12:74. doi: 10.1186/1471-2466-12-74.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-014038-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNVA237A2208
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.