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

Tracking Information

First Received Date ^ICMJE

August 1, 2007

Last Updated Date

January 15, 2008

Start Date ^ICMJE

August 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Safety and tolerability of 28 days of treatment, based on all safety data including vital signs, ECGs, laboratory evaluations, spirometry and adverse events.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00510510 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

• Mean trough forced expiratory volume in 1 second (FEV1)at Day 28 and Day 1 • FEV1 over time for 8 time points on Day 1, Day 14 and Day 28 • Forced vital capacity (FVC) over time for 10 time points on Day 1 and Day 28 and 8 time points post-dosin

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Tolerability of 28 Days Treatment With Glycopyrrolate(NVA237) (100 or 200µg Once a Day) in Patients With Moderate to Severe COPD

Official Title ^ICMJE

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 200µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^ICMJE

Drug: Glycopyrrolate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

240

Completion Date

January 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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 1is 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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France, Germany, Netherlands, Spain, Turkey

Administrative Information

NCT ID ^ICMJE

NCT00510510

Responsible Party

external affairs, novartis

Study ID Numbers ^ICMJE

CNVA237A2206

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP