Efficacy and Safety of Four Doses of Glycopyrronium Bromide in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00501852

Purpose

This study will assess the efficacy and safety of glycopyrronium bromide in patients with stable COPD, in comparison to an active comparator.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: NVA237 Drug: Placebo Drug: Tiotropium	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, 4 Period Incomplete Block Cross-Over, Multi-Center, Multiple Dose (7 Days) Dose-Ranging Study to Assess the Efficacy and Safety of 4 Doses of NVA237 in Patients With Stable COPD, Compared to Seven Days Treatment With Tiotropium (18μg Once Daily, Open Label) as an Active Control

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide Tiotropium Glycopyrrolate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

The efficacy of NVA237 in patients with stable COPD - trough forced expiratory volume in 1 second (mean of 23h 15min and 23h 45min post dose) following 7 days of treatment, by comparing four doses of NVA237 (12.5, 25, 50 and 100 μg o.d.) with placebo [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Individual timepoint FEV1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment:	83
Study Start Date:	July 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental NVA237 12.5 µg	Drug: NVA237 12.5 µg once daily (od) via single-dose dry-powder inhaler (SDDPI)
2: Experimental NVA237 25 µg	Drug: NVA237 25 µg od via SDDPI
3: Experimental NVA237 50 µg	Drug: NVA237 50 µg od via SDDPI
4: Experimental NVA237 100 µg	Drug: NVA237 100 µg od via SDDPI
5: Placebo Comparator Placebo	Drug: Placebo via SDDPI
6: Active Comparator Tiotropium bromide	Drug: Tiotropium 18 µg od via SDDPI

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
Patients with moderate to severe COPD according to the Gold Guidelines (2006).
Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2. For non-Japanese patients predicted FEV1 should be calculated according to Quanjer predictive equations [Quanjer PH 1993], for Japanese patients predicted FEV1 should be calculated according to Japanese Respiratory Society predictive tables [Japan Respiratory Society 2001].

Exclusion Criteria:

Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
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 between Visit 1 and Visit 3.
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrowangle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.
Patients with a history of asthma indicated by (but not limited to):
1. Blood eosinophil count > 400/mm3
2. Onset of symptoms prior to age 40 years.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501852

Locations

Belgium
Novartis Investigator Site
Vilvoorde, Belgium
France
Novartis Investigator Site
Rueil-Malmaison,, France
Japan
Novartis Investigator site
Tokyo, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CNVA237A2205
Study First Received:	July 13, 2007
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00501852 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:

COPD, Age≥40 yrs, Glycopyrronium Bromide

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Respiration Disorders
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Adjuvants, Anesthesia
Muscarinic Antagonists

Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Lung Diseases
Glycopyrrolate
Therapeutic Uses
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Central Nervous System Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 27, 2009