- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03344406
A Study to Evaluate Conceptual Saturation of Evaluating Respiratory Symptoms (E-RS) in Subjects With Asthma
April 12, 2019 updated by: GlaxoSmithKline
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15241
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects with asthma
Subjects with moderate to severe asthma will be interviewed via telephone.
Subjects will complete a daily diary including the E-RS: COPD and supplemental asthma items for 7 days.
|
Qualitative concept elicitation telephone interviews will be conducted in subjects with asthma.
E-RS questionnaire will directly measure respiratory symptom severity.
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.
Subjects will complete a daily diary including the E-RS: COPD and supplemental asthma items for 7 days.
Sociodemographic questionnaire will capture subject's demographic characteristics, including age, gender, and the highest level of educational attainment.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects attending semi-structured interview
Time Frame: Up to 7 days
|
A semi-structured interview guide will introduce and direct the discussion during the interview session.
It will be used to elicit concepts of moderate to severe asthma symptoms and impacts as well as to assess the overall comprehension of the E-RS: COPD and supplemental asthma items.
The interview guide is also designed to elicit from subjects how they used the provided response options to answer each item and provide them the opportunity to report if there are missing categories or if they could not respond to the item with the given response option.
|
Up to 7 days
|
Number of subjects completing E-RS questionnaire in COPD
Time Frame: Up to 7 days
|
The E-RS: COPD questionnaire consists of 11 items from the 14 item exacerbations of COPD (EXACT-PRO) instrument.
The 11-items will be scored on a 5-point scale ranging from "not at all" to "extreme".
Items of the E-RS: COPD will capture information related to respiratory symptoms such as breathlessness, cough, sputum production, chest congestion, and chest tightness.
The daily recording of information with the E-RS: COPD will allow assessment of underlying day-to-day variability of a subject's symptoms.
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Up to 7 days
|
Number of subjects completing supplemental asthma items
Time Frame: Up to 7 days
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Two supplemental asthma items will be asked in conjunction with the E-RS: COPD questionnaire, including: a question on wheezing, a symptom of importance in asthma, and an item on breathlessness with activities to evaluate shortness of breath associated with strenuous activities.
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Up to 7 days
|
Number of subjects completing daily diary
Time Frame: Up to 7 days
|
Subjects will complete a paper-pen daily diary including the E-RS: COPD and supplemental asthma items for 7 days.
Several questions related to the relevance of the E-RS: COPD and supplemental asthma items will be asked to subjects.
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Up to 7 days
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Number of subjects completing sociodemographic questionnaire
Time Frame: Up to 7 days
|
The sociodemographic questionnaire is a brief, self-administered questionnaire, which includes items to capture subject's demographic characteristics, including age, gender, and the highest level of educational attainment.
Subjects will complete the sociodemographic questionnaire at the time of the interview.
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Up to 7 days
|
Number of subjects completing clinical questionnaire
Time Frame: Up to 7 days
|
The clinical questionnaire is a brief, self-administered questionnaire, which includes questions about the number of asthma exacerbations in the past 12 months, absenteeism due to asthma in the past month, and the presence of comorbid conditions.
Subjects will complete the clinical questionnaire at the time of the interview.
|
Up to 7 days
|
Time to diagnosis of asthma based on clinical data form
Time Frame: Up to 7 days
|
Clinicians will complete time to asthma diagnosis in clinical data form for each subject upon enrollment.
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Up to 7 days
|
Number of subjects with exacerbation history based on clinical data form
Time Frame: Up to 7 days
|
Clinicians will complete exacerbation history in clinical data form for each subject upon enrollment.
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Up to 7 days
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Number of subjects with other health conditions based on clinical data form
Time Frame: Up to 7 days
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Clinicians will complete information of any other health condition in clinical data form for each asthmatic subject upon enrollment.
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Up to 7 days
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Number of subjects receiving maintenance therapy based on clinical data form
Time Frame: Up to 7 days
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Clinicians will complete information of subjects receiving maintenance therapy in clinical data form.
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Up to 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Actual)
September 10, 2018
Study Completion (Actual)
September 10, 2018
Study Registration Dates
First Submitted
November 13, 2017
First Submitted That Met QC Criteria
November 13, 2017
First Posted (Actual)
November 17, 2017
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 12, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 206605
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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