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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: No intervention

• Study Type: Observational
• Enrollment (Actual): 1084

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 25249
      • GSK Investigational Site
  • Arizona
    • Tucson, Arizona, United States, 85741
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • National City, California, United States, 91950
      • GSK Investigational Site
    • Rancho Mirage, California, United States, 92270
      • GSK Investigational Site
    • Riverside, California, United States, 92506
      • GSK Investigational Site
    • Santa Ana, California, United States, 92704
      • GSK Investigational Site
    • Walnut Creek, California, United States, 94598
      • GSK Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • GSK Investigational Site
    • Colorado Springs, Colorado, United States, 80909
      • GSK Investigational Site
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • GSK Investigational Site
  • Florida
    • Cocoa, Florida, United States, 32927
      • GSK Investigational Site
    • DeLand, Florida, United States, 32720
      • GSK Investigational Site
    • Largo, Florida, United States, 33770
      • GSK Investigational Site
    • Miami, Florida, United States, 33186
      • GSK Investigational Site
    • Miami, Florida, United States, 33183
      • GSK Investigational Site
    • Naranja, Florida, United States, 33032
      • GSK Investigational Site
    • South Miami, Florida, United States, 33143
      • GSK Investigational Site
    • Tamarac, Florida, United States, 33321
      • GSK Investigational Site
    • Tampa, Florida, United States, 33613
      • GSK Investigational Site
    • Winter Park, Florida, United States, 32789
      • GSK Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47711
      • GSK Investigational Site
    • Indianapolis, Indiana, United States, 46229
      • GSK Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • GSK Investigational Site
    • Sunset, Louisiana, United States, 70584
      • GSK Investigational Site
  • Maine
    • Biddeford, Maine, United States, 04005
      • GSK Investigational Site
  • Minnesota
    • Rochester, Minnesota, United States, 55904
      • GSK Investigational Site
  • New York
    • Albany, New York, United States, 12205
      • GSK Investigational Site
  • North Carolina
    • Mooresville, North Carolina, United States, 28117
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 27609
      • GSK Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • GSK Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • GSK Investigational Site
    • Cincinnati, Ohio, United States, 45231
      • GSK Investigational Site
    • Dayton, Ohio, United States, 45439
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • GSK Investigational Site
    • Oklahoma City, Oklahoma, United States, 73112
      • GSK Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97213
      • GSK Investigational Site
  • Pennsylvania
    • Clairton, Pennsylvania, United States, 15205
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15243
      • GSK Investigational Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • GSK Investigational Site
    • Easley, South Carolina, United States, 29650
      • GSK Investigational Site
    • Gaffney, South Carolina, United States, 29340
      • GSK Investigational Site
    • Greenville, South Carolina, United States, 29615
      • GSK Investigational Site
    • Mount Pleasant, South Carolina, United States, 29464
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
    • Union, South Carolina, United States, 29379
      • GSK Investigational Site
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • GSK Investigational Site
    • Milan, Tennessee, United States, 38358
      • GSK Investigational Site
    • New Tazewell, Tennessee, United States, 37824-1409
      • GSK Investigational Site
  • Texas
    • Boerne, Texas, United States, 78006
      • GSK Investigational Site
    • Houston, Texas, United States, 77054
      • GSK Investigational Site
    • Killeen, Texas, United States, 76542
      • GSK Investigational Site
    • Plano, Texas, United States, 75024
      • GSK Investigational Site
    • Waco, Texas, United States, 76712
      • GSK Investigational Site
    • Wichita Falls, Texas, United States, 76309
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No group	Drug: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: November 13, 2008
• First Submitted That Met QC Criteria: November 13, 2008
• First Posted (Estimate): November 14, 2008

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 24, 2014
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Spirometry; Chronic Obstructive Pulmonary Disease (COPD)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 111891