AsthmaNCT04031261
National Validation and Sensitivity to Change of the SAQ
An observational study of Asthma and Severe Asthma, run by University Hospital Plymouth NHS Trust at 5 sites in United Kingdom.
Trial summary
DESIGN A multi-centre mixed methods study of a new asthma specific quality of life questionnaire including limited clinic data. AIMS To collect further quantitative data to validate a new asthma quality of life scale, the Severe Asthma Questionnaire (SAQ). Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Asthma, Severe Asthma
- How many people
- 410 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 10 Apr 2019to 23 Mar 2020
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients must have a diagnosis of severe asthma, be taking high dose inhaled corticosteroids (GINA step 4 \& 5), and be aged 16 years or over.
Who may be able to join
- All patients must have a diagnosis of severe asthma, be taking high dose inhaled corticosteroids (GINA step 4 \& 5), and be aged 16 years or over.
- Patients commencing a biologic treatment for their severe asthma (GINA step 4 \& 5), as per NICE guidelines.
Who cannot join
- Patients that are unwilling to participate will be excluded from the study.
- In the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma, which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe Chronic Obstructive Pulmonary Disease (COPD).
- The SAQ is currently only translated into British English. Therefore, if the participant is unable to read in English, they will be unable to participate.
- Part 2: Sensitivity to change
- Patients will be excluded from the study if they are unwilling to participate
- In the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe COPD.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Royal Devon & Exeter Hospital
Exeter, EX2 5DW
Royal Brompton Hospital
London, SW3 6NP
Wythenshawe Hospital - Manchester
Manchester, M23 9LT
University Hopsitals Plymouth NHS Trust
Plymouth, Pl4 8DH
About this study
Official title: National Validation and Sensitivity to Change of a Scale to Measure Quality of Life in Patients With Severe Asthma
DESIGN A multi-centre mixed methods study of a new asthma specific quality of life questionnaire including limited clinic data.
AIMS To collect further quantitative data to validate a new asthma quality of life scale, the Severe Asthma Questionnaire (SAQ).
Read more
To determine the Minimum Clinically Important Difference (MCID) of the SAQ
OUTCOME MEASURES
Questionnaires:
- The Severe Asthma Questionnaire (SAQ)
- The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
- The EQ-5D-5L
- The Asthma Control Test (ACT)/ Asthma Control Questionnaire (ACQ)
- Global Rating of Change Questionnaire (GRCQ) Clinical data comprises:
- Spirometry
- BMI
- Asthma severity
- Health care utilisation: ED attendance in the last 12 months, Hospital admissions in the last 12 months;
- Number of exacerbations in the last 12 months requiring OCS Prednisolone dose mg/day (if oral steroid dependent).
POPULATION All patients aged 16 years or over, who have attended one of three participating UK specialist asthma centres for the validation study and with data also collected from Derriford Hospital's Chest Clinic (DHCC) for use in determining Minimum clinically Important difference.
ELIGIBILITY Over 16 years of age Diagnosis of Severe Asthma
DURATION 18 months
- Conditions
- Asthma, Severe Asthma
- Keywords
- Quality of Life, Patient Reported Outcomes
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| National Validation | All patients must have a diagnosis of severe asthma, be taking high dose inhaled corticosteroids (GINA step 4 \& 5), and be aged 16 years or over. | |
| Sensitivity to Change | Patients commencing a biologic treatment for their severe asthma (GINA step 4 \& 5), as per National Institute for Health and Care Excellence (NICE) guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe Asthma Questionnaire (SAQ) score
The new questionnaire will provide a combined assessment of disease and its treatment on the quality of life of patients with severe asthma. The scale is based on existing Health Related Quality of Life (HRQoL) scales but modified for the severe population and provides assessments of the effect of asthma symptoms and the effect of asthma medicines. The SAQ was produced from detailed qualitative research. The questionnaire has 16 items, scored on a 1-7 scale (a higher score indicating better quality of life). The mean score of these 16 questions is calculated to produce an overall score.
An additional 3 items are included to asses overall HRQoL, and HRQoL during different months of the year. These three questions are scored on a 100 point scale with a higher score indicating better HRQoL.
Measured: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months)
Change in Severe Asthma Questionnaire (SAQ) score
The Severe Asthma Questionnaire (SAQ) will be collected at 5 time points and matched with the Global Rating of Change questionnaire at these time points to determine the SAQ's Minimum Clinically Important Difference (MCID).
The questionnaire has 16 items, scored on a 1-7 scale (a higher score indicating better quality of life). The mean score of these 16 questions is calculated to produce an overall score.
An additional 3 items are included to asses overall HRQoL, and HRQoL during different months of the year. These three questions are scored on a 100 point scale with a higher score indicating better HRQoL.
Measured: Part 2: Sensitivity to change: Collected at 0 (baseline) 4, 8, 12 & 16 weeks, (enrollment period of 10 months)
Secondary outcomes (5)
The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
This 15-item scale is commonly used as the quality of life scale in asthma studies. It consists of 15 questions which are scored on on a 1-7 scale, with a higher score indicating better health related quality of life. Whilst the MiniAQLQ can be scored as four separate domains (Symptoms, Activity Limitations, Emotional Functional and Environmental Stimuli), these will not be used. Instead the mean score of the 15 questions will be used as the MiniAQLQ score.
For the purpose of validation, we wish to show that this scale correlates with the burden of symptoms but not, or with a much lower correlation, with the burden of treatment.
Measured: Part 1: National Validation & Part 2: Sensitivity to change - Collected at 0 (baseline) weeks, within two weeks after enrollment (enrollment period of 6 or 10 months respectively)
Asthma Control Test (ACT)
Note: Recruiting sites are able to chose which Asthma Control Patient Reported Outcome (PRO) to contribute data for, (The ACT or the ACQ).
The Asthma Control Test (ACT) is a 5-item scale is commonly used as a measure of asthma control in asthma studies. It is scored on a scale of 1-5 with a higher score indicating better asthma control. For the purpose of validation, we wish to show that this scale correlates with the burden of symptoms but not, or with a much lower correlation, with the burden of treatment.
Measured: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months), Part 2: Sensitivity to change - Collected at 0 (baseline) 4, 8, 12 & 16 weeks
Asthma Control Questionnaire (ACQ)
The Asthma Control Questionnaire (ACQ) contains 7 items and takes into consideration FEV1% predicted and daily use of rescue bronchodilator. Patients respond to 7 items concerning their symptom severity on a 0-6 scale (0 = no impairment, 6 = maximum impairment). The mean of the 7-items will be used as the score of the ACQ.
Measured: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment, Part 2: Sensitivity to change - Collected at 0 (baseline) 4, 8, 12 & 16 weeks
EQ-5D-5L
This is a 5-item scale scored from 1-5 with a higher score indicating worse health. For the purposes of this study, the mean score of the five items will be used as the score for the EQ5D. In addition to the 5 items, the EQ-5D-5L also includes a category rating scale to rate their quality of life on the day of completion. This is scored from 0-100 with a higher score indicating better health.
This scale is commonly used in clinical trials to determine improvement in patients' perceived quality of life.
The correlations between EQ-5D-5L scores and SAQ scores will be explored.
Measured: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months) , Part 2: Sensitivity to change - Collected at 0 (baseline) & 16 weeks within 2 weeks of enrollment
Change in Global Rating of Change Questionnaire (GRCQ)
This scale will be used by participants to indicate how much better they feel since commencing a biologic treatment for asthma. The 11-point scale ranges from -5 (a great deal worse) to 5 (A great deal better).
Measured: Part 2: Sensitivity to change - Collected at 4, 8, 12 & 16 weeks within 2 weeks of enrollment (enrollment period of 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start10 Apr 2019
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
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.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Plymouth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031261
- Sponsor's protocol ID
- 18/P/089
- Status last verified
- Jun 2019
- First submitted
- 28 Jun 2019
- Last updated
- 6 Jan 2021
- 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 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Validation and Sensitivity to Change of a Scale to Measure Quality of Life in Patients With Severe Asthma
- ClinicalTrials.gov ID
- NCT04031261
- Acronym / sponsor ID
- 18/P/089
- Conditions
- Asthma, Severe Asthma
- Keywords
- Quality of Life, Patient Reported Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Collaborators
- University of Plymouth
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 24 Jul 2019 (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.
DESIGN A multi-centre mixed methods study of a new asthma specific quality of life questionnaire including limited clinic data.
AIMS To collect further quantitative data to validate a new asthma quality of life scale, the Severe Asthma Questionnaire (SAQ).
To determine the Minimum Clinically Important Difference (MCID) of the SAQ
OUTCOME MEASURES
Questionnaires:
- The Severe Asthma Questionnaire (SAQ)
- The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
- The EQ-5D-5L
- The Asthma Control Test (ACT)/ Asthma Control Questionnaire (ACQ)
- Global Rating of Change Questionnaire (GRCQ) Clinical data comprises:
- Spirometry
- BMI
- Asthma severity
- Health care utilisation: ED attendance in the last 12 months, Hospital admissions in the last 12 months;
- Number of exacerbations in the last 12 months requiring OCS Prednisolone dose mg/day (if oral steroid dependent).
POPULATION All patients aged 16 years or over, who have attended one of three participating UK specialist asthma centres for the validation study and with data also collected from Derriford Hospital's Chest Clinic (DHCC) for use in determining Minimum clinically Important difference.
ELIGIBILITY Over 16 years of age Diagnosis of Severe Asthma
DURATION 18 months
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| National Validation | – | –All patients must have a diagnosis of severe asthma, be taking high dose inhaled corticosteroids (GINA step 4 \& 5), and be aged 16 years or over. |
| Sensitivity to Change | – | –Patients commencing a biologic treatment for their severe asthma (GINA step 4 \& 5), as per National Institute for Health and Care Excellence (NICE) guidelines. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients must have a diagnosis of severe asthma, be taking high dose inhaled corticosteroids (GINA step 4 \& 5), and be aged 16 years or over.
Key inclusion criteria (2 listed)
- All patients must have a diagnosis of severe asthma, be taking high dose inhaled corticosteroids (GINA step 4 \& 5), and be aged 16 years or over.
- Patients commencing a biologic treatment for their severe asthma (GINA step 4 \& 5), as per NICE guidelines.
Key exclusion criteria (6 listed)
- Patients that are unwilling to participate will be excluded from the study.
- In the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma, which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe Chronic Obstructive Pulmonary Disease (COPD).
- The SAQ is currently only translated into British English. Therefore, if the participant is unable to read in English, they will be unable to participate.
- Part 2: Sensitivity to change
- Patients will be excluded from the study if they are unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severe Asthma Questionnaire (SAQ) score
Time frame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months)
The new questionnaire will provide a combined assessment of disease and its treatment on the quality of life of patients with severe asthma. The scale is based on existing Health Related Quality of Life (HRQoL) scales but modified for the severe population and provides assessments of the effect of asthma symptoms and the effect of asthma medicines. The SAQ was produced from detailed qualitative research. The questionnaire has 16 items, scored on a 1-7 scale (a higher score indicating better quality of life). The mean score of these 16 questions is calculated to produce an overall score. An additional 3 items are included to asses overall HRQoL, and HRQoL during different months of the year. These three questions are scored on a 100 point scale with a higher score indicating better HRQoL.
Change in Severe Asthma Questionnaire (SAQ) score
Time frame: Part 2: Sensitivity to change: Collected at 0 (baseline) 4, 8, 12 & 16 weeks, (enrollment period of 10 months)
The Severe Asthma Questionnaire (SAQ) will be collected at 5 time points and matched with the Global Rating of Change questionnaire at these time points to determine the SAQ's Minimum Clinically Important Difference (MCID). The questionnaire has 16 items, scored on a 1-7 scale (a higher score indicating better quality of life). The mean score of these 16 questions is calculated to produce an overall score. An additional 3 items are included to asses overall HRQoL, and HRQoL during different months of the year. These three questions are scored on a 100 point scale with a higher score indicating better HRQoL.
5 secondary outcomes
The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
Time frame: Part 1: National Validation & Part 2: Sensitivity to change - Collected at 0 (baseline) weeks, within two weeks after enrollment (enrollment period of 6 or 10 months respectively)
Asthma Control Test (ACT)
Time frame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months), Part 2: Sensitivity to change - Collected at 0 (baseline) 4, 8, 12 & 16 weeks
Asthma Control Questionnaire (ACQ)
Time frame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment, Part 2: Sensitivity to change - Collected at 0 (baseline) 4, 8, 12 & 16 weeks
EQ-5D-5L
Time frame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months) , Part 2: Sensitivity to change - Collected at 0 (baseline) & 16 weeks within 2 weeks of enrollment
Change in Global Rating of Change Questionnaire (GRCQ)
Time frame: Part 2: Sensitivity to change - Collected at 4, 8, 12 & 16 weeks within 2 weeks of enrollment (enrollment period of 10 months)
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 6 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Severe Asthma, run by University Hospital Plymouth NHS Trust at 5 sites in United Kingdom.
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 2 inclusion and 6 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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?
Severe Asthma Questionnaire (SAQ) score (time frame: Part 1: National Validation - Only cross-sectional data recorded within 2 weeks after enrollment (enrollment period of 6 months)). The study lists 2 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 6 Jan 2021.