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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00791518
First received: November 13, 2008
Last updated: October 18, 2012
Last verified: October 2012
  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
Pulmonary Disease, Chronic Obstructive
Drug: No intervention

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome 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) ] [ Designated as safety issue: No ]
    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 Outcome 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The number of participants with the indicated affected medical conditions were counted.


Enrollment: 1084
Study Start Date: December 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No group
No group
Drug: No intervention
No intervention

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 57 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00791518     History of Changes
Other Study ID Numbers: 111891
Study First Received: November 13, 2008
Results First Received: March 25, 2010
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Chronic Obstructive Pulmonary Disease (COPD)
Spirometry

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014