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Completed

NCT Number: NCT00791518

Evaluation of Lung Function and Symptoms in Patients Diagnosed 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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Drug

No intervention

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Acronym: LABD

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 14, 2008
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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