Clinical trial NCT03344406: A Study to Evaluate Conceptual Saturation of Evaluating Respiratory Symptoms (E-RS) in Subjects With Asthma
Official title: Assessing the Adequacy of the Evaluating Respiratory Symptoms in COPD (E-RS:COPD™) Measure Among Patients With Moderate to Severe Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Telephone interview
Cross-sectional
Qualitative research
E-RS: COPD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Evidera
First posted: 2017-11-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 32 subjects with moderate to severe asthma will be included in the study. Of these, approximately 25 will be English-speaking and 5-7 Spanish-speaking subjects. All subjects will be recruited from up to approximately 10 clinical sites in the United States and Canada.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects attending semi-structured interview
timeFrame: Up to 7 days
measure: Number of subjects completing E-RS questionnaire in COPD
timeFrame: Up to 7 days
measure: Number of subjects completing supplemental asthma items
timeFrame: Up to 7 days
measure: Number of subjects completing daily diary
timeFrame: Up to 7 days
measure: Number of subjects completing sociodemographic questionnaire
timeFrame: Up to 7 days
measure: Number of subjects completing clinical questionnaire
timeFrame: Up to 7 days
measure: Time to diagnosis of asthma based on clinical data form
timeFrame: Up to 7 days
measure: Number of subjects with exacerbation history based on clinical data form
timeFrame: Up to 7 days
measure: Number of subjects with other health conditions based on clinical data form
timeFrame: Up to 7 days
measure: Number of subjects receiving maintenance therapy based on clinical data form
timeFrame: Up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: