A Study to Evaluate Conceptual Saturation of Evaluating Respiratory Symptoms (E-RS) in Subjects With Asthma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/16/2019 |
| Start Date: | December 1, 2017 |
| End Date: | February 1, 2019 |
Assessing the Adequacy of the Evaluating Respiratory Symptoms in COPD (E-RS:COPD™) Measure Among Patients With Moderate to Severe Asthma
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.
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.
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.
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