40 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 ValuePrimary· Day 1 of the 2-week Run-in Period
Cronbach's alpha (CA) is a measure of the IC of the 13-item SOBDA questionnaire (completed via electronic diary by a sample of participants). It is the ratio of the variance (var.) of the sum of the individual scores and the var. of the total score. The var. of the sum of a group of independent variables is the sum of their var.; thus, if the variables are positively correlated, the var. of the sum will be increased. If the items making up the score are identical and so perfectly correlated, CA=1. If the items are independent, CA=0. Higher scores indicate a more reliable (precise) instrument.
Group
Value
95% CI
All Participants: 2-week Run-in Period
0.892
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 PeriodPrimary· Week 1 and Week 2 of the 2-week Run-in Period
T-RR=stability during repeat measures over time in a stable population. SOBDA score was determined by the 13-item (it.) scoring algorithm, assigning a weekly mean score of 1-4 (higher scores=more severe breathlessness with daily activities) based on the mean of 7 days of data (or \>=4 days). Daily total score is computed from the mean of the participant's (par.) scores on the 13 it. (\>=7 it. must have non-missing responses). Only scores of stable par. (indicating no change \[score=3\] on the par.-completed Patient Global Assessment of Change \[PGAC\]; 1 \[ much worse\] to 5 \[much better\]) w
Group
Value
95% CI
All Participants: 2-week Run-in Period
0.01
± 0.244
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 2Primary· 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 is defined as the ability of the SOBDA questionnaire to measure required information and was assessed by examining the relationship between the SOBDA score and the participant/physician-completed mMRC Dyspnea Scale assessments. The physician/participant rated the degree of the participant's dyspnea (trouble breathing) on the 5-point mMRC scale (0, none; 4, very severe). Spearman's rank correlation coefficient assesses if the relationship between two variables is monotone. A correlation of +1 or -1 will occur if one variable is a perfect monotone of the other.
Physician-completed mMRC, n=339
Group
Value
95% CI
All Participants: 2-week Run-in Period
0.24
Participant-completed mMRC, n=340
Group
Value
95% CI
All Participants: 2-week Run-in Period
0.29
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 2Primary· 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 is defined as the ability of the SOBDA questionnaire to measure the required information and was assessed by examining the relationship between the SOBDA score with the CGI-S score. Spearman's rank correlation coefficient assesses if the relationship between two variables is monotone. A correlation of +1 or -1 will occur if one variable is a perfect monotone of the other. Clinicians were asked to assess the severity of the participant's dyspnea on the CGI-S scale. This was evaluated on a 1-4 Likert scale: 1 (mild) to 4 (very severe).
Group
Value
95% CI
All Participants: 2-week Run-in Period
0.24
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 2Primary· 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 is defined as the ability of the SOBDA questionnaire to measure required information and was assessed by examining the relationship between the SOBDA score and the CRQ-SAS dyspnea domain score. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 will occur if the data from the 2 variables lie exactly on a line. The CRQ is a 20-item instrument measuring 4 domains (each measured on a scale of 1 \[maximum impairment\] to 7 \[no impairment\]) of functioning: mastery, fatigue, emotional function, and dyspnea.
Group
Value
95% CI
All Participants: 2-week Run-in Period
-0.68
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 2Primary· Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)
SOBDA known group validity refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the PyC mMRC. The physician rated the degree of the participant's dyspnea on the 5-point mMRC scale: 0 (none) to 4 (very severe). Known group validity was confirmed if the SOBDA score increased with increasing values of PyC mMRC, both indicating increased levels of breathlessness.
PyC mMRC: 0 to 1, n=12
Group
Value
95% CI
All Participants: 2-week Run-in Period
1.78
± 0.196
PyC mMRC: 2, n=200
Group
Value
95% CI
All Participants: 2-week Run-in Period
2.08
± 0.048
PyC mMRC: 3, n=117
Group
Value
95% CI
All Participants: 2-week Run-in Period
2.28
± 0.063
PyC mMRC: 4, n=10
Group
Value
95% CI
All Participants: 2-week Run-in Period
2.73
± 0.216
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 2Primary· Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)
SOBDA known group validity refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the ParC mMRC. The participant rated the degree of his/her dyspnea on the 5-point mMRC scale: 0 (none) to 4 (very severe). Known group validity was confirmed if the SOBDA score increased with increasing values of ParC mMRC, both indicating increased levels of breathlessness.
ParC mMRC: 0, n=12
Group
Value
95% CI
All Participants: 2-week Run-in Period
1.92
± 0.192
ParC mMRC: 1, n=103
Group
Value
95% CI
All Participants: 2-week Run-in Period
1.94
± 0.066
ParC mMRC: 2, n=138
Group
Value
95% CI
All Participants: 2-week Run-in Period
2.20
± 0.056
ParC mMRC: 3, n=65
Group
Value
95% CI
All Participants: 2-week Run-in Period
2.26
± 0.083
ParC mMRC: 4, n=22
Group
Value
95% CI
All Participants: 2-week Run-in Period
2.73
± 0.142
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 2Primary· Baseline (last week of the 2-week Run-in Period) and pre-treatement on Visit 2 (Day 1 of the 6-week Treatment Period)
SOBDA KGV refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the CGI-S score. Clinicians were asked to assess the severity of the participant's dyspnea on the CGI-S scale. This was evaluated on a 1-4 Likert scale: 1 (mild) to 4 (very severe). KGV was confirmed if the SOBDA score increased with increasing values of CGI-S, both indicating increased levels of breathlessness.
CGI-S: 1, n=19
Group
Value
95% CI
All Participants: 2-week Run-in Period
1.87
± 0.156
CGI-S: 2, n=236
Group
Value
95% CI
All Participants: 2-week Run-in Period
2.11
± 0.045
CGI-S: 3, n=78
Group
Value
95% CI
All Participants: 2-week Run-in Period
2.33
± 0.080
CGI-S: 4, n=5
Group
Value
95% CI
All Participants: 2-week Run-in Period
2.72
± 0.305
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)Primary· Days 8, 15, 22, 29, 36, and 43 and Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
The PGAC is par. completed on a 1-5 scale: 1, much worse; 2, worse; 3, no change; 4, better; 5, much better. Responders were defined as par. with a rating of "better" or "much better" (score of 4 or 5) on the PGAC at the relevant week; non-responders were defined as par. with a response of "much worse," "worse," or "no change" on the PGAC. As pre-specified in the study protocol, results are presented independent of treatment allocation . The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.
Responders, Day 8 (Baseline to Week 1), n=293
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
105
Non-responders, Day 8 (Baseline to Week 1), n=293
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
188
Responders, Day 15 (Week 1 to Week 2), n=303
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
91
Non-responders, Day 15 (Week 1 to Week 2), n=303
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
212
Responders, Day 22 (Week 2 to Week 3), n=299
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
83
Non-responders, Day 22 (Week 2 to Week 3), n=299
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
216
Responders, Day 29 (Week 3 to Week 4), n=285
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
62
Non-responders, Day 29 (Week 3 to Week 4), n=285
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
223
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)Primary· 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)
Responsiveness reflects the ability of the SOBDA questionnaire to detect change under conditions of known change. Responders (Rs)=participants (par.) with a rating of "better"/"much better" (score of 4/5) on the PGAC (range; 1 \[much worse\] to 5 \[much better\]) at the relevant week; NRs=par. with a response of "much worse," "worse," or "no change" (score of 3). Mean difference between Rs and NRs in the change from the previous week to the current week's SOBDA score was calculated. For Visit 3/PD, the change from Baseline to the last treatment week's SOBDA score for Rs and NRs was calculated.
Baseline to Day 8, responders, n=105
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
-0.26
± 0.324
Baseline to Day 8, non-responders, n=188
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
-0.01
± 0.254
Day 8 to Day 15, responders, n=91
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
-0.10
± 0.280
Day 8 to Day 15, non-responders, n=212
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
0.01
± 0.222
Day 15 to Day 22, responders, n=83
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
-0.08
± 0.223
Day 15 to Day 22, non-responders, n=216
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
0.02
± 0.183
Day 22 to Day 29, responders, n=62
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
-0.09
± 0.198
Day 22 to Day 29, non-responders, n=223
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
0.01
± 0.193
Number of Participants Classified as Responders and Non-responders by Clinician Global Impression of Change Question (CGI-C) Response at Visit 3/PDPrimary· Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
Clinicians were asked to provide their clinical impression regarding change in the participant's shortness of breath by CGI-C. This was evaluated on a 1-5 Likert scale: 1 (much worse) to 5 (much better), with 3 being no change. A CGI-C responder was defined as a participant who had a response of "better" (4) or "much better" (5), and a non-responder was defined as a participant who had a response of "much worse" (1), "worse" (2), or "no change" (3).
Responders
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
120
Non-responders
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
181
Number of Participants Classified as Responders and Non-responders by CRQ-SAS Dyspnea Domain Response at Visit 3/PDPrimary· Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)
A CRQ-SAS dyspnea domain responder was defined as a participant who had a score increase of 0.5 units or more for the dyspnea domain of the CRQ-SAS between Visit 2 and Visit 3/Premature Discontinuation. A non-responder was defined as a participant who had a decrease in the score, or an increase of less than 0.5 units.
Responders
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
117
Non-responders
Group
Value
95% CI
MITT Population: 6-Week Treatment Period
184
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 29 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00984659.