Clinical trial NCT00510510: 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
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Study, to Assess the Safety and Tolerability of 28 Days Treatment With NVA237 (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
glycopyrronium bromide
antimuscarinic
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-02
Enrollment: 281
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Male or female adults aged 40 years or older
* 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 requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to visit 1 or during the screening period (up to visit 3).
* 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.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
timeFrame: 28 days
Secondary outcomes:
measure: Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day
timeFrame: 28 Days
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Novartis investigative site
state: Arizona
city: Phoenix
country: United States
facility: Novartis investigative site
state: Arizona
city: Wheat Ridge
country: United States
facility: Novartis investigative site
state: Colorado
city: Newark
country: United States
facility: Novartis investigative site
state: Delaware
city: Miami
country: United States
facility: Novartis investigative site
state: Florida
city: Miami
country: United States
facility: Novartis investigative site
state: Florida
city: Tamarac
country: United States
facility: Novartis investigative site
state: Florida
city: River Forest
country: United States
facility: Novartis investigative site
state: Illinois
city: Overland Park
country: United States
facility: Novartis investigative site
state: Kansas
city: St. Chares
country: United States
facility: Novartis investigative site
state: Missouri
city: Charlotte
country: United States
facility: Novartis investigative site
state: North Carolina
city: Portland
country: United States
facility: Novartis investigative site
state: Oregon
city: Spartanburg
country: United States
facility: Novartis investigative site
state: South Carolina
city: Union
country: United States
facility: Novartis investigative site
state: South Carolina
city: Ft Worth
country: United States
facility: Novartis investigative site
state: Texas
city: Houston
country: United States
facility: Novartis investigative site
state: Texas
city: Rueil-Malmaison
country: France
facility: Novartis investigative site
city: Nurnberg
country: Germany
facility: Novartis investigative site
city: Arnhem
country: Netherlands
facility: Novartis investigative site
city: Barcelona
country: Spain
facility: Novartis investigative site
city: Istanbul
country: Turkey
facility: Novartis investigative site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: 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.