Status:
COMPLETED
A Study to Evaluate Conceptual Saturation of Evaluating Respiratory Symptoms (E-RS) in Subjects With Asthma
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Evidera
Conditions:
Asthma
Eligibility:
All Genders
18+ years
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 10 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03344406
Start Date
December 1 2017
End Date
September 10 2018
Last Update
April 16 2019
Active Locations (1)
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1
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241