A Study to Evaluate Conceptual Saturation of Evaluating Respiratory Symptoms (E-RS) in Subjects With Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-09-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subjects with asthma

Subjects with moderate to severe asthma will be interviewed via telephone. Subjects will complete a daily diary including the E-RS: COPD and supplemental asthma items for 7 days.

Telephonic interviews

Intervention Type OTHER

Qualitative concept elicitation telephone interviews will be conducted in subjects with asthma.

E-RS: COPD

Intervention Type OTHER

E-RS questionnaire will directly measure respiratory symptom severity.

Supplemental asthma items

Intervention Type OTHER

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.

Daily diary

Intervention Type OTHER

Subjects will complete a daily diary including the E-RS: COPD and supplemental asthma items for 7 days.

Sociodemographic questionnaire

Intervention Type OTHER

Sociodemographic questionnaire will capture subject's demographic characteristics, including age, gender, and the highest level of educational attainment.

Clinical questionnaire

Intervention Type OTHER

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.

Interventions

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Telephonic interviews

Qualitative concept elicitation telephone interviews will be conducted in subjects with asthma.

Intervention Type OTHER

E-RS: COPD

E-RS questionnaire will directly measure respiratory symptom severity.

Intervention Type OTHER

Supplemental asthma items

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.

Intervention Type OTHER

Daily diary

Subjects will complete a daily diary including the E-RS: COPD and supplemental asthma items for 7 days.

Intervention Type OTHER

Sociodemographic questionnaire

Sociodemographic questionnaire will capture subject's demographic characteristics, including age, gender, and the highest level of educational attainment.

Intervention Type OTHER

Clinical questionnaire

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or older at the time of consent.
* History of airflow obstruction as indicated by a pre-bronchodilator forced expiratory volume in one second (FEV1) \<80 percent predicted recorded in the previous 12 months.
* Documented evidence of a reversibility assessment within the previous 12 months, which demonstrated a post-bronchodilator increase in FEV1 of \>=12 percent and \>= 200 milliliters (mL).
* Diagnosed with moderate or severe asthma as defined by a stable maintenance inhaled corticosteroid (ICS) dose for at least 12 weeks prior to screening of; moderate: medium ICS dose \> 250 and \<=500 micrograms per day (mcg/day) fluticasone propionate (or equivalent) based on the total daily maintenance treatment dose; Severe: high ICS dose \> 500 mcg/day fluticasone propionate (or equivalent) based on the total daily maintenance treatment dose.
* Documented control status defined using the asthma control questionnaire (ACQ-6) items (ACQ-6) obtained at the time of screening.
* Able to understand, read and speak English or Spanish sufficiently to complete all assessments.
* Willing and able to take part in a telephone interview session.
* Willing and able to provide written informed consent.

Exclusion Criteria

* Is a current smoker.
* Has any medical condition that would preclude participation in this study, including the presence of emphysema or chronic bronchitis (COPD other than asthma) or a clinically important lung condition other than asthma such as current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis or diagnoses of an eosinophilic disorder such as eosinophilic esophagitis or a history of lung cancer.
* Participated in an interventional study within the past 30 days.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No