Asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory conditions involving the small airways with airflow limitations resulting from genetic and environmental interactions. Currently, there are no existing subject diaries with evidence of responsiveness to measure the daily symptoms of asthma. Therefore, there is a need to either develop a new symptom diary to characterize subject burden of asthma symptoms or modify/adapt an existing tool from a related disease area for use in subjects with moderate to severe asthma. The E-RS in COPD (E-RS: COPD®) questionnaire was developed as a measure of daily respiratory symptoms associated with COPD. The fixed dose combination of fluticasone furoate/ umeclidinium/ vilanterol (FF/UMEC/VI) administered via the ELLIPTA® dry powder inhaler (DPI) has been developed for the treatment of asthma. This cross-sectional, qualitative study is designed to understand the symptoms and disease experience of subjects with moderate to severe asthma. This study will also evaluate underlying concepts that are most important to asthmatic subjects compared to symptoms and concepts included in the E-RS: COPD and two supplemental asthma items (wheeze and shortness of breath with physical activity). Approximately 32 subjects will be included in the study and interviewed via telephone. Each interview including time for consent, qualitative interview, and completion of case report forms (CRFs) is expected to last approximately 60 to 90 minutes. Subjects will be expected to complete a daily diary for the next 7 days, following the initial telephone interview. E-RS: COPD and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.
Study Type
OBSERVATIONAL
Enrollment
25
Qualitative concept elicitation telephone interviews will be conducted in subjects with asthma.
E-RS questionnaire will directly measure respiratory symptom severity.
Supplemental asthma items will include one question on wheeze and an item on breathlessness with activities to evaluate shortness of breath associated with strenuous activities.
Subjects will complete a daily diary including the E-RS: COPD and supplemental asthma items for 7 days.
Sociodemographic questionnaire will capture subject's demographic characteristics, including age, gender, and the highest level of educational attainment.
Clinical questionnaire will capture subject's clinical characteristics including the number of asthma exacerbations in the past 12 months, absenteeism due to asthma in the past month, and the presence of comorbid conditions.
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
Number of subjects attending semi-structured interview
A semi-structured interview guide will introduce and direct the discussion during the interview session. It will be used to elicit concepts of moderate to severe asthma symptoms and impacts as well as to assess the overall comprehension of the E-RS: COPD and supplemental asthma items. The interview guide is also designed to elicit from subjects how they used the provided response options to answer each item and provide them the opportunity to report if there are missing categories or if they could not respond to the item with the given response option.
Time frame: Up to 7 days
Number of subjects completing E-RS questionnaire in COPD
The E-RS: COPD questionnaire consists of 11 items from the 14 item exacerbations of COPD (EXACT-PRO) instrument. The 11-items will be scored on a 5-point scale ranging from "not at all" to "extreme". Items of the E-RS: COPD will capture information related to respiratory symptoms such as breathlessness, cough, sputum production, chest congestion, and chest tightness. The daily recording of information with the E-RS: COPD will allow assessment of underlying day-to-day variability of a subject's symptoms.
Time frame: Up to 7 days
Number of subjects completing supplemental asthma items
Two supplemental asthma items will be asked in conjunction with the E-RS: COPD questionnaire, including: a question on wheezing, a symptom of importance in asthma, and an item on breathlessness with activities to evaluate shortness of breath associated with strenuous activities.
Time frame: Up to 7 days
Number of subjects completing daily diary
Subjects will complete a paper-pen daily diary including the E-RS: COPD and supplemental asthma items for 7 days. Several questions related to the relevance of the E-RS: COPD and supplemental asthma items will be asked to subjects.
Time frame: Up to 7 days
Number of subjects completing sociodemographic questionnaire
The sociodemographic questionnaire is a brief, self-administered questionnaire, which includes items to capture subject's demographic characteristics, including age, gender, and the highest level of educational attainment. Subjects will complete the sociodemographic questionnaire at the time of the interview.
Time frame: Up to 7 days
Number of subjects completing clinical questionnaire
The clinical questionnaire is a brief, self-administered questionnaire, which includes questions about the number of asthma exacerbations in the past 12 months, absenteeism due to asthma in the past month, and the presence of comorbid conditions. Subjects will complete the clinical questionnaire at the time of the interview.
Time frame: Up to 7 days
Time to diagnosis of asthma based on clinical data form
Clinicians will complete time to asthma diagnosis in clinical data form for each subject upon enrollment.
Time frame: Up to 7 days
Number of subjects with exacerbation history based on clinical data form
Clinicians will complete exacerbation history in clinical data form for each subject upon enrollment.
Time frame: Up to 7 days
Number of subjects with other health conditions based on clinical data form
Clinicians will complete information of any other health condition in clinical data form for each asthmatic subject upon enrollment.
Time frame: Up to 7 days
Number of subjects receiving maintenance therapy based on clinical data form
Clinicians will complete information of subjects receiving maintenance therapy in clinical data form.
Time frame: Up to 7 days
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