Evaluation of Lung Function and Symptoms in Patients With COPD on Long-Acting Bronchodilator Monotherapy - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00791518

Purpose

A multicenter study to evaluate lung function and symptoms in subjects with COPD who have been on regular use of only one long-acting bronchodilator.

Condition	Intervention
Chronic Obstructive Pulmonary Disease (COPD)	Drug: No intervention

Study Type:	Observational
Study Design:	Prospective
Official Title:	An Evaluation of Lung Function and Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Percentage of subjects shose post albuterol forced expiratory volume in one second is les than 80 percent of predicted normal [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects whose post albuterol forced expiratory volume in one second is less than 50 percent of predicted normal [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Post albuterol forced expiratory volume in one second and forced vital capacity ratios of all subjects [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Dyspnea scores on the Modified Medical Research Council Dypnea Scale [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Subject reports of the number of COPD exacerbationsn in the past 12 months that required systemic corticosteroids, antibiotics, and or hospitalization [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Subject reports of average number of puffs from all short acting bronchodilator MDI and or number of nebules used in the past 2 weeks [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Subject reports of diagnosis and or treatment for specifi medical conditions related to cardiovascular, psychiatric (anxiety or depression) and or bone disorders [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
No group No group	Drug: No intervention No intervention

Eligibility

Study Population

Patients with COPD who are on only one long acting bronchodilator medication to control their COPD symptoms.

Criteria

Inclusion Criteria:

Cigaretter smoking history-Current or ex-smokers (defined as stopped smoking for at least three months prior to the study visit
Established history of COPD as diagnosed by a physician
Regular use (prescribed for use every day) of only one long-acting bronchodilatory greater than or equal to one month before the study visit
Ability to read, comprehend, and record information in the English language

Exclusion Criteria:

Currently active asthma (receiving asthma therapy and or having asthma symptoms)
Use of ipratropium/albuterol bombination products greater than three times per day, use of inhaled corticosteroids, use of inhaled corticosteroid/long-acting beta-agonist combinations, theophylline preparations, or oral beta agonists within 3 months prior to the study visit
Previous lung surgery
Other respirotory disorders other than COPD
Current alcohol, illegal drug, or solvent abuse
Females with a positive urine pregnancy test at the study visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791518

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111891, ADC111891
Study First Received:	November 13, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00791518
Health Authority:	United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Spirometry

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009