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
NCT ID: NCT00510510
Last Updated: 2012-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
281 participants
INTERVENTIONAL
2007-08-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NVA237 100 µg
NVA237 100 µg
Dry powder inhalation once a day for up to 28 days
NVA237 200 µg
NVA237 200 µg
Dry powder inhalation once a day for up to 28 days
Placebo
Placebo
Placebo to NVA237 dry powder inhalation once a day for up to 28 days
Interventions
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NVA237 100 µg
Dry powder inhalation once a day for up to 28 days
Placebo
Placebo to NVA237 dry powder inhalation once a day for up to 28 days
NVA237 200 µg
Dry powder inhalation once a day for up to 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with moderate to severe COPD according to the GOLD Guidelines (2006)
* Patients who have smoking history of at least 10 pack years
* Patients with a post-bronchodilator Forced Expiratory Volume in One Second (FEV1) equal or greater than 30% of the predicted normal value and less than 80% of the predicted normal value, and post-bronchodilator FEV1/FVC less than 0.7 at visit 2
* Written informed consent by the patient prior to initiation of any study-related procedure
Exclusion Criteria
* Patients who have had a respiratory tract infection within 6 weeks prior to visit 1 or during the screening period (up to visit 3).
* Patients with a history of asthma indicated by (but not limited to):
Blood eosinophil count \> 400/mm3, onset of symptoms prior to age 40 years.
* Patients with a history of long QT syndrome or whose QTc measured at visit 1 is prolonged (more than 440 ms for males or more than 460 ms for females).
* Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
* Patients who, in the judgment of the investigator have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia, narrow-angle glaucoma, symptomatic prostatic hyperplasia, bladder-neck obstruction or moderate to severe renal impairment that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
40 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Novartis investigative site
Glendale, Arizona, United States
Novartis investigative site
Phoenix, Arizona, United States
Novartis investigative site
Wheat Ridge, Colorado, United States
Novartis investigative site
Newark, Delaware, United States
Novartis investigative site
Miami, Florida, United States
Novartis investigative site
Miami, Florida, United States
Novartis investigative site
Tamarac, Florida, United States
Novartis investigative site
River Forest, Illinois, United States
Novartis investigative site
Overland Park, Kansas, United States
Novartis investigative site
Saint Chares, Missouri, United States
Novartis investigative site
Charlotte, North Carolina, United States
Novartis investigative site
Portland, Oregon, United States
Novartis investigative site
Spartanburg, South Carolina, United States
Novartis investigative site
Union, South Carolina, United States
Novartis investigative site
Fort Worth, Texas, United States
Novartis investigative site
Houston, Texas, United States
Novartis investigative site
Rueil-Malmaison, , France
Novartis investigative site
Nuremberg, , Germany
Novartis investigative site
Arnhem, , Netherlands
Novartis investigative site
Barcelona, , Spain
Novartis investigative site
Istanbul, , Turkey (Türkiye)
Countries
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References
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Vogelmeier C, Verkindre C, Cheung D, Galdiz JB, Guclu SZ, Spangenthal S, Overend T, Henley M, Mizutani G, Zeldin RK. Safety and tolerability of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients. Pulm Pharmacol Ther. 2010 Oct;23(5):438-44. doi: 10.1016/j.pupt.2010.04.005. Epub 2010 Apr 21.
Other Identifiers
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CNVA237A2206
Identifier Type: -
Identifier Source: org_study_id
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