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

Overview

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.

Full Title of Study: “An Evaluation of Lung Function and Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2009

Interventions

  • Drug: No intervention
    • No intervention

Arms, Groups and Cohorts

  • No group
    • No group

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal
    • Time Frame: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
    • 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.

Secondary Measures

  • Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal
    • Time Frame: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
    • 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.
  • Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios
    • Time Frame: Day 1 of a 1-day study
    • 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).
  • Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%
    • Time Frame: Day 1 of a 1-day study
    • 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).
  • Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%
    • Time Frame: Day 1 of a 1-day study
    • 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).
  • Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%
    • Time Frame: Day 1 of a 1-day study
    • The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.
  • Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%
    • Time Frame: Day 1 of 1-day study
    • The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.
  • Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%
    • Time Frame: Day 1 of 1-day study
    • The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.
  • Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%
    • Time Frame: Day 1 of 1-day study
    • The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.
  • Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%
    • Time Frame: Day 1 of a 1-day study
    • The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.
  • Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%
    • Time Frame: Day 1 of a 1-day study
    • The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.
  • 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
    • Time Frame: Day 1 of a 1-day study
    • The number of participants with the indicated affected medical conditions were counted.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

References

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.

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