Phase 4 N=418 Randomized Double-blind Other

Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

Bottom Line

View on ClinicalTrials.gov: NCT00984659 ↗

Enrolled (actual)

418

Serious AEs

3.3%

Results posted

Mar 2012

Primary outcome: Primary: 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 — 0.892 ratio of variance

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Fluticasone propionate/salmeterol combination product (Drug); Salmeterol (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	0.892	—
PRIMARY 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	0.01	0.713
PRIMARY 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	0.24; 0.29	—
PRIMARY 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	0.24	—
PRIMARY 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	-0.68	—
PRIMARY 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	1.78; 2.08; 2.28; 2.73	<0.001 sig
PRIMARY 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	1.92; 1.94; 2.20; 2.26; 2.73	<0.001 sig
PRIMARY 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	1.87; 2.11; 2.33; 2.72	0.008 sig
PRIMARY 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)	105; 188; 91; 212; 83; 216	—
PRIMARY 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)	-0.26; -0.01; -0.10; 0.01; -0.08; 0.02	<0.001 sig
PRIMARY Number of Participants Classified as Responders and Non-responders by Clinician Global Impression of Change Question (CGI-C) Response at Visit 3/PD	120; 181	—
PRIMARY Number of Participants Classified as Responders and Non-responders by CRQ-SAS Dyspnea Domain Response at Visit 3/PD	117; 184	—
PRIMARY Number of Participants Classified as Responders and Non-responders by Physician-completed and Participant-completed mMRC Response at Visit 3/PD	91; 210; 92; 209	—
PRIMARY Change From Baseline to Last Treatment Week in the SOBDA Score by CGI-C Responses at Visit 3/PD	-0.25; -0.03	<0.001 sig
PRIMARY Change From Baseline to Last Treatment Week in the SOBDA Score by CRQ-SAS Dyspnea Domain (DD) Responses at Visit 3/PD	-0.32; 0.01	<0.001 sig
PRIMARY Change From Baseline to Last Treatment Week in the SOBDA Score by Physician-completed mMRC and Participant-completed mMRC Responses at Visit 3/PD	-0.13; -0.11; -0.18; -0.09	0.535
PRIMARY 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"	-0.26; -0.08; -0.08; -0.10; -0.08; -0.05	—
PRIMARY 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"	-0.25	—
PRIMARY 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"	-0.13	—
PRIMARY 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	-0.16	—

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.

Eligibility Criteria

Inclusion Criteria

Adults ≥ 40 years of age
Established clinical history of COPD by ATS/ERS definition
Former or current smoker > 10 pack years
Evidence of dyspnea

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00984659). 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.