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

NCT03344406 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2019-04-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Telephonic interviews

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

OTHER

E-RS: COPD

E-RS questionnaire will directly measure respiratory symptom severity.

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.

OTHER

Daily diary

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

OTHER

Sociodemographic questionnaire

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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-09-10
Completion
2018-09-10

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344406 on ClinicalTrials.gov