Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy

Pulmonary Disease, Chronic Obstructive Clinical Trial

— LABD  

Official title:

An Evaluation of Lung Function and Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791518
• Other study ID #: 111891
• Status: Completed
• Phase: N/A
• First received: November 13, 2008
• Last updated: July 24, 2014
• Start date: December 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1084
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Cigarette 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 bronchodilator 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 combination 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 respiratory disorders other than COPD

• Current alcohol, illegal drug, or solvent abuse

• Females with a positive urine pregnancy test at the study visit

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albany	New York
United States	GSK Investigational Site	Anderson	South Carolina
United States	GSK Investigational Site	Biddeford	Maine
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boerne	Texas
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Clairton	Pennsylvania
United States	GSK Investigational Site	Cocoa	Florida
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	DeLand	Florida
United States	GSK Investigational Site	Easley	South Carolina
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Gaffney	South Carolina
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Johnson City	Tennessee
United States	GSK Investigational Site	Killeen	Texas
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Milan	Tennessee
United States	GSK Investigational Site	Mooresville	North Carolina
United States	GSK Investigational Site	Mount Pleasant	South Carolina
United States	GSK Investigational Site	Naranja	Florida
United States	GSK Investigational Site	National City	California
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	New Tazewell	Tennessee
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Rancho Mirage	California
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Rochester	Minnesota
United States	GSK Investigational Site	Salisbury	North Carolina
United States	GSK Investigational Site	Santa Ana	California
United States	GSK Investigational Site	South Miami	Florida
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Stamford	Connecticut
United States	GSK Investigational Site	Sunset	Louisiana
United States	GSK Investigational Site	Tamarac	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Union	South Carolina
United States	GSK Investigational Site	Waco	Texas
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	Wichita Falls	Texas
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dransfield MT, Bailey W, Crater G, Emmett A, O'Dell DM, Yawn B. Disease severity and symptoms among patients receiving monotherapy for COPD. Prim Care Respir J. 2011 Mar;20(1):46-53. doi: 10.4104/pcrj.2010.00059. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal	The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.	Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)	No
Secondary	Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal	The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) <50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.	Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)	No
Secondary	Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios	The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).	Day 1 of a 1-day study	No
Secondary	Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%	The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).	Day 1 of a 1-day study	No
Secondary	Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%	The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).	Day 1 of a 1-day study	No
Secondary	Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%	The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.	Day 1 of a 1-day study	No
Secondary	Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%	The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.	Day 1 of 1-day study	No
Secondary	Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%	The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.	Day 1 of 1-day study	No
Secondary	Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%	The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.	Day 1 of 1-day study	No
Secondary	Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%	The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.	Day 1 of a 1-day study	No
Secondary	Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%	The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.	Day 1 of a 1-day study	No
Secondary	Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups	The number of participants with the indicated affected medical conditions were counted.	Day 1 of a 1-day study	No