N/A
N=1,084
Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00791518 ↗Enrolled (actual)
1,084
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcome: Primary: Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal — 70; 30 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal |
70; 30 | — |
| SECONDARY Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal |
23; 77 | — |
| SECONDARY Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios |
689; 383 | — |
| SECONDARY Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80% |
1.7; 1.6 | — |
| SECONDARY Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50% |
1.9; 1.6 | — |
| SECONDARY Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80% |
41; 7 | — |
| SECONDARY Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50% |
16; 32 | — |
| SECONDARY Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80% |
246; 117 | — |
| SECONDARY Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50% |
79; 284 | — |
| SECONDARY Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80% |
3.8; 2.3 | — |
| SECONDARY Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50% |
5.2; 2.8 | — |
| SECONDARY 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 |
389; 134; 123; 400; 87; 24 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00791518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.