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

GlaxoSmithKline1 site in 1 country1,084 target enrollmentDecember 2008

ConditionsPulmonary Disease, Chronic Obstructive

InterventionsNo intervention

DrugsNo intervention

Overview

Phase: Not Applicable
Intervention: No intervention
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Enrollment: 1084
Locations: 1
Primary Endpoint: Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

May 2009

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

No group

Intervention: No intervention

Outcomes

Primary Outcomes

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

Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%(Day 1 of a 1-day study)
Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal(Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered))
Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%(Day 1 of 1-day study)
Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios(Day 1 of a 1-day study)
Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%(Day 1 of a 1-day study)
Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%(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(Day 1 of a 1-day study)
Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%(Day 1 of 1-day study)
Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%(Day 1 of a 1-day study)
Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%(Day 1 of 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%(Day 1 of a 1-day study)