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

Trough Forced Expiratory Volume in 1 Second (FEV1) Following 7 Days of Treatment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 15min and 23h 45min post dosing.

Secondary Outcome Measures:

Least Squares Means of FEV1 (L) at Day 1, by Timepoint [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
FEV1 was measured at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 23 hours and 15 minutes, and 23 hours and 45 minutes post dose.

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

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

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00501852 History of Changes
Other Study ID Numbers:	CNVA237A2205
Study First Received:	July 13, 2007
Results First Received:	December 22, 2010
Last Updated:	December 22, 2010
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:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Glycopyrrolate
Tiotropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Anesthesia

Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 12, 2012