AsthmaNCT03344406
A Study to Evaluate Conceptual Saturation of Evaluating Respiratory Symptoms (E-RS) in Subjects With Asthma
An observational study of Asthma, run by GlaxoSmithKline at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Telephonic interviews, E-RS: COPD and Supplemental asthma items
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 10 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- Telephonic interviews, E-RS: COPD, Supplemental asthma items, Daily diary, Sociodemographic questionnaire
- Keywords
- Asthma, Telephone interview, Cross-sectional, Qualitative research, E-RS: COPD
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephonic interviewsOther
Qualitative concept elicitation telephone interviews will be conducted in subjects with asthma.
E-RS: COPDOther
E-RS questionnaire will directly measure respiratory symptom severity.
Supplemental asthma itemsOther
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.
Daily diaryOther
Subjects will complete a daily diary including the E-RS: COPD and supplemental asthma items for 7 days.
Sociodemographic questionnaireOther
Sociodemographic questionnaire will capture subject's demographic characteristics, including age, gender, and the highest level of educational attainment.
Clinical questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telephonic interviews; Other: E-RS: COPD; Other: Supplemental asthma items; Other: Daily diary; Other: Sociodemographic questionnaire; Other: Clinical questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects attending semi-structured interview
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.
Measured: Up to 7 days
Number of subjects completing E-RS questionnaire in COPD
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.
Measured: Up to 7 days
Number of subjects completing supplemental asthma items
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.
Measured: Up to 7 days
Number of subjects completing daily diary
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.
Measured: Up to 7 days
Number of subjects completing sociodemographic questionnaire
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.
Measured: Up to 7 days
Number of subjects completing clinical questionnaire
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.
Measured: Up to 7 days
Time to diagnosis of asthma based on clinical data form
Clinicians will complete time to asthma diagnosis in clinical data form for each subject upon enrollment.
Measured: Up to 7 days
Number of subjects with exacerbation history based on clinical data form
Clinicians will complete exacerbation history in clinical data form for each subject upon enrollment.
Measured: Up to 7 days
Number of subjects with other health conditions based on clinical data form
Clinicians will complete information of any other health condition in clinical data form for each asthmatic subject upon enrollment.
Measured: Up to 7 days
Number of subjects receiving maintenance therapy based on clinical data form
Clinicians will complete information of subjects receiving maintenance therapy in clinical data form.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Dec 2017
- Primary completion10 Sep 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Evidera
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344406
- Sponsor's protocol ID
- 206605
- Status last verified
- Apr 2019
- First submitted
- 13 Nov 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Adequacy of the Evaluating Respiratory Symptoms in COPD (E-RS:COPD™) Measure Among Patients With Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT03344406
- Acronym / sponsor ID
- 206605
- Conditions
- Asthma
- Keywords
- Asthma, Telephone interview, Cross-sectional, Qualitative research, E-RS: COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Evidera
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with asthma | – | Other: Telephonic interviews, Other: E-RS: COPD, Other: Supplemental asthma items, Other: Daily diary, Other: Sociodemographic questionnaire, Other: Clinical questionnaireSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephonic interviewsQualitative concept elicitation telephone interviews will be conducted in subjects with asthma. | Other | Subjects with asthma |
| E-RS: COPDE-RS questionnaire will directly measure respiratory symptom severity. | Other | Subjects with asthma |
| Supplemental asthma itemsSupplemental asthma items will include one question on wheeze and an item on breathlessness with activities to evaluate shortness of breath associated with strenuous activities. | Other | Subjects with asthma |
| Daily diarySubjects will complete a daily diary including the E-RS: COPD and supplemental asthma items for 7 days. | Other | Subjects with asthma |
| Sociodemographic questionnaireSociodemographic questionnaire will capture subject's demographic characteristics, including age, gender, and the highest level of educational attainment. | Other | Subjects with asthma |
| Clinical questionnaireClinical 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. | Other | Subjects with asthma |
Primary outcome
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.
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.
Number of subjects completing supplemental asthma items
Time frame: Up to 7 days
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.
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.
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.
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.
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.
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.
Number of subjects with other health conditions based on clinical data form
Time frame: Up to 7 days
Clinicians will complete information of any other health condition in clinical data form for each asthmatic subject upon enrollment.
Number of subjects receiving maintenance therapy based on clinical data form
Time frame: Up to 7 days
Clinicians will complete information of subjects receiving maintenance therapy in clinical data form.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects attending semi-structured interview (time frame: Up to 7 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.