Validation of a New Shortness of Breath with Daily Activities Questionnaire in patients with Chronic Obstructive Pulmonary Disease
Trial overview
Internal Consistency (IC) of the Shortness of Breath with Daily Activities (SOBDA) questionnaire in participants with Chronic Obstructive Pulmonary Disease (COPD) assessed as Cronbach's alpha value
Timeframe: Day 1 of the 2-week Run-in Period
Test-retest reliability (T-RR) of SOBDA scores measured as the difference in the SOBDA weekly score between Week 1 and Week 2 of the 2-week Run-in Period
Timeframe: Week 1 and Week 2 of the 2-week Run-in Period
Convergent validity for the SOBDA questionnaire measured as correlations of the Baseline SOBDA score with Participant-completed Modified Medical Research Council (mMRC) and Physician-completed mMRC scores at Visit 2
Timeframe: Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)
Convergent validity for the SOBDA questionnaire measured as the correlation of the Baseline SOBDA score with the Clinician Global Assessment of Dyspnea Severity (CGI-S) score at Visit 2
Timeframe: Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)
Convergent validity (CV) for the SOBDA questionnaire measured as the correlation of the Baseline SOBDA score with the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) dyspnea domain score at Visit 2
Timeframe: Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)
Known group validity for the SOBDA questionnaire measured as the comparison of the Baseline SOBDA score in the indicated categories of the Physician-completed (PyC) mMRC score at Visit 2
Timeframe: Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)
Known group validity for the SOBDA questionnaire measured as the comparison of the Baseline SOBDA score in the indicated categories of the Participant-completed (ParC) mMRC score at Visit 2
Timeframe: Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)
Known group validity (KGV) for the SOBDA questionnaire measured as the comparison of the Baseline SOBDA score in the indicated categories of CGI-S scores at Visit 2
Timeframe: Baseline (last week of the 2-week Run-in Period) and pre-treatement on Visit 2 (Day 1 of the 6-week Treatment Period)
Participants (par.) classified as responders/non-responders according to the Patient Global Assessment of Change (PGAC) response at Days 8, 15, 22, 29, 36, and 43 and at Visit 3/Premature Discontinuation (PD) (the end of the 6-week Treatment Period or PD)
Timeframe: Days 8, 15, 22, 29, 36, and 43 and Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
Change from the previous week to the current week’s SOBDA score by participant-completed PGAC response at Days 8, 15, 22, 29, 36, and 43 and at Visit 3/PD (end of the 6-week Treatment Period or PD)
Timeframe: Baseline; Days 8, 15, 22, 29, 36, and 43 and Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
Number of participants classified as responders and non-responders by Clinician Global Impression of Change Question (CGI-C) response at Visit 3/PD
Timeframe: Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
Number of participants classified as responders and non-responders by CRQ-SAS Dyspnea domain response at Visit 3/PD
Timeframe: Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
Number of participants classified as responders and non-responders by Physician-completed and Participant-completed mMRC response at Visit 3/PD
Timeframe: Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
Change from Baseline to Last Treatment Week in the SOBDA score by CGI-C responses at Visit 3/PD
Timeframe: Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
Change from Baseline to Last Treatment Week in the SOBDA score by CRQ-SAS Dyspnea Domain (DD) responses at Visit 3/PD
Timeframe: Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
Change from Baseline to Last Treatment Week in the SOBDA score by Physician-completed mMRC and Participant-completed mMRC responses at Visit 3/PD
Timeframe: Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
SOBDA threshold for response assessed as mean change from the previous week’s SOBDA score based on a participant-completed PGAC score rated of “better”
Timeframe: Baseline (last week of the 2-week Run-in Period) and Weeks 1, 2, 3, 4, 5, and 6 (6-week Treatment Period)
SOBDA threshold for response as assessed by mean change from Baseline to the Last Treatment Week in the SOBDA score based on a CGI-C response rated as “better”
Timeframe: Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
SOBDA threshold for response as assessed by mean change from Baseline to the Last Treatment Week in the SOBDA score based on a CRQ-SAS Dyspnea Domain (DD) response rated as “better”
Timeframe: Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
SOBDA threshold for response assessed as mean change from Baseline to Last Treatment Week in the SOBDA score based on Forced Expiratory Volume in one second (FEV1) change from Baseline of 50 milliliters (mL) to <100 mL
Timeframe: Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
Participation criteria
- Adults ≥ 40 years of age
- Established clinical history of COPD by ATS/ERS definition
- Has a respiratory disorder other than COPD
- Cancer not in complete clinical remission
- Adults ≥ 40 years of age
- Established clinical history of COPD by ATS/ERS definition
- Former or current smoker > 10 pack years
- Evidence of dyspnea
- Has a respiratory disorder other than COPD
- Cancer not in complete clinical remission
- Clinically significant cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine, or hematological abnormalities that are uncontrolled
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.