Last updated: 01/12/2021 10:40:06
A study to evaluate conceptual saturation of Evaluating Respiratory Symptoms (E-RS) in subjects with asthma
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Assessing the Adequacy of the Evaluating Respiratory Symptoms in COPD (E-RS:COPD™) Measure among Patients with Moderate to Severe Asthma
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects attending semi-structured interview
Timeframe: Up to 7 days
Number of subjects completing E-RS questionnaire in COPD
Timeframe: Up to 7 days
Number of subjects completing supplemental asthma items
Timeframe: Up to 7 days
Number of subjects completing daily diary
Timeframe: Up to 7 days
Number of subjects completing sociodemographic questionnaire
Timeframe: Up to 7 days
Number of subjects completing clinical questionnaire
Timeframe: Up to 7 days
Time to diagnosis of asthma based on clinical data form
Timeframe: Up to 7 days
Number of subjects with exacerbation history based on clinical data form
Timeframe: Up to 7 days
Number of subjects with other health conditions based on clinical data form
Timeframe: Up to 7 days
Number of subjects receiving maintenance therapy based on clinical data form
Timeframe: Up to 7 days
Secondary outcomes:
Not applicable
Interventions:
Other: Telephonic interviews
Other: E-RS: COPD
Other: Supplemental asthma items
Other: Daily diary
Other: Sociodemographic questionnaire
Other: Clinical questionnaire
Enrollment:
25
Observational study model:
Cohort
Primary completion date:
2018-10-09
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
Collaborators
Evidera
Study date(s)
December 2017 to September 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2018-10-09
Actual study completion date
2018-10-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website