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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510510
• Other study ID #: CNVA237A2206
• Status: Completed
• Phase: Phase 2
• First received: August 1, 2007
• Last updated: May 14, 2012
• Start date: August 2007
• Est. completion date: January 2008

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Netherlands: Medicines Evaluation Board (MEB)Spain: Spanish Agency of MedicinesTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	Novartis investigative site	Rueil-Malmaison
Germany	Novartis investigative site	Nurnberg
Netherlands	Novartis investigative site	Arnhem
Spain	Novartis investigative site	Barcelona
Turkey	Novartis investigative site	Istanbul
United States	Novartis investigative site	Charlotte	North Carolina
United States	Novartis investigative site	Ft Worth	Texas
United States	Novartis investigative site	Glendale	Arizona
United States	Novartis investigative site	Houston	Texas
United States	Novartis investigative site	Miami	Florida
United States	Novartis investigative site	Miami	Florida
United States	Novartis investigative site	Newark	Delaware
United States	Novartis investigative site	Overland Park	Kansas
United States	Novartis investigative site	Phoenix	Arizona
United States	Novartis investigative site	Portland	Oregon
United States	Novartis investigative site	River Forest	Illinois
United States	Novartis investigative site	Spartanburg	South Carolina
United States	Novartis investigative site	St. Chares	Missouri
United States	Novartis investigative site	Tamarac	Florida
United States	Novartis investigative site	Union	South Carolina
United States	Novartis investigative site	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)	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.	28 days	Yes
Secondary	Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day	Forced expiratory volume maneuvers recorded using a calibrated spirometer. Trough forced expiratory volume in one second (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.	28 Days	No