Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200µg Once a Day) in Patients With Moderate to Severe COPD - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00510510

Purpose

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

Condition	Intervention	Phase
Chronic Obstructive Airway Disease	Drug: NVA237 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Glycopyrrolate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.

Secondary Outcome Measures:

Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Forced expiratory volume maneuvers recorded using a calibrated spirometer. Trough FEV1 on Days 1 & 28 defined as the mean of the FEV1 values measured at 23 hours 15 minutes and 23 hours 45 minutes post-dose.

Enrollment:	281
Study Start Date:	August 2007
Study Completion Date:	January 2008

Arms	Assigned Interventions
Active Comparator: NVA237 100 µg	Drug: NVA237
Active Comparator: NVA237 200 µg	Drug: NVA237
Placebo Comparator: Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510510

Show 21 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vogelmeier C, Verkindre C, Cheung D, Galdiz JB, Güçlü 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. Epub 2010 Apr 21.

Responsible Party:	external affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00510510 History of Changes
Other Study ID Numbers:	CNVA237A2206
Study First Received:	August 1, 2007
Results First Received:	December 23, 2010
Last Updated:	March 8, 2011
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB); Spain: Spanish Agency of Medicines; Turkey: Ministry of Health

Keywords provided by Novartis:

COPD, glycopyrronium bromide, antimuscarinic

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Glycopyrrolate
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012