Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary Disease
Summary
The purpose of this study is to evaluate a new questionnaire to capture the patient experience of COPD. The information collected will be used to validate the Shortness of Breath with Daily Activities Questionnaire.
Timeline
- Start
- 2009-10-29
- Primary completion
- 2010-07-01
- Completion
- 2010-07-01
Outcome
Mixed primary results
registry Known group validity was confirmed if the SOBDA score increased with increasing values of PyC mMRC, both indicating increased levels of breathlessness. NCT00984659 ↗
registry analysis (superiority or other test); All Participants: 2-week Run-in Period; p <0.001; ANCOVA; note: Analysis of covariance (ANCOVA) adjusted for age, gender, and percent predicted Forced Expiratory volume in one second (FEV1) at Screening. NCT00984659 ↗
registry analysis (superiority or other test); MITT Population: 6-Week Treatment Period; p = 0.535; Median Difference (Final Values) 0.03 (95% CI -0.08 to 0.15); ANCOVA; note: ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for Physician-Completed mMRC responders and non-responders NCT00984659 ↗
registry analysis (superiority or other test); MITT Population: 6-Week Treatment Period; p = 0.08; Median Difference (Final Values) 0.08 (95% CI -0.02 to 0.19); ANCOVA; note: ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparison of mean SOBDA score for Participant-Completed mMRC responders and non-responders NCT00984659 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone propionate | Other / unclassified | 250 ug | — |
| Subject | Salmeterol | Other / unclassified | 50 ug | — |