Severe Asthma Clinical Trial
— BoBSAOfficial title:
Body Reprogramming as an Adjunct to Biologic Administration in Patients With Severe Asthma: a Feasibility Study
NCT number | NCT04980755 |
Other study ID # | 2109166 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 28, 2021 |
Est. completion date | June 30, 2022 |
There are many symptoms associated with severe asthma, not all of them related to the lung. These are referred to as extra-pulmonary symptoms and their relationship with quality of life is complex. Body reprogramming (BR) is a non-drug intervention originally developed for fibromyalgia patients with the aim of improving health and wellbeing in a personalised way, with evidence-based lifestyle changes. The frequency and severity of multiple symptoms in severe asthma is similar to fibromyalgia and the investigators propose that BR may be a suitable non-drug intervention for severe asthma patients who are about to step up drug treatment. Our study aims are therefore to assess how BR may be suitable for people with severe asthma, and to adapt and optimise the programme for these people. In two phases, severe asthma patients will be recruited via a regional severe asthma clinic at the Royal Devon & Exeter NHS Trust and invited to take part in a short course of BR. In phase one, patients will be asked to attend four weekly researcher-led sessions of BR via video call and be given practice tasks to report on at the subsequent session. Questionnaires will be completed for the first and last session. At the end of BR, patients will also be invited to take part in a focus group. The data collected will inform development of the programme for phase two, which will involve recruitment of severe asthma patient who are about to start biologic drug treatment for their severe asthma
Status | Recruiting |
Enrollment | 32 |
Est. completion date | June 30, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Phase one: - Aged =18 years attending the regional specialist severe asthma service in Royal Devon and Exeter hospitals. - Diagnosed with severe asthma as per ERS/ATS definition. - Requiring high dose inhaled corticosteroids (NICE definition of high dose ICS). - Eight or more non-respiratory symptoms per week (approximately 60% of patients with severe asthma have a moderate or high extra-pulmonary symptom burden) as measured by the General Symptom Questionnaire - Phase two: - Diagnosed with severe asthma as per ERS/ATS definition. - Requiring high dose inhaled corticosteroids (NICE definition of high dose ICS). - Patients with severe asthma who have been approved for biologic treatment according to national guidance and have been assessed by a multi-disciplinary team will be offered the intervention pending starting their biologic treatment. - Patients with eight or more non-respiratory symptoms per week as measured by the GSQ. Exclusion Criteria: - Phase one and Phase two - Unable or unwilling to partake. - In the opinion of the patient's treating physician, the patient has another condition which is significantly impairs their ability to take part in the BR. - No access to the internet or appropriate IT equipment. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Devon and Exeter Hospital | Exeter | Devon |
Lead Sponsor | Collaborator |
---|---|
Royal Devon and Exeter NHS Foundation Trust | Plymouth Marjon University, University of Plymouth |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of participants taking part and completing week 1 of the course | This information will be used to gain insight into participants' willingness to attend four online course. Any decline in attendance will be observed, and reasons for this can be explored in the focus groups or one to one interviews. | Week 1 | |
Primary | Percentage of participants taking part and completing week 2 of the course | See outcome 1 | Week 2 | |
Primary | Percentage of participants taking part and completing week 3 of the course. | See outcome 1 | Week 3 | |
Primary | Percentage of participants taking part and completing week 4 of the course | See outcome 1 | Week 4 | |
Primary | Number and percentage of participants who complete the study questionnaires | By capturing this information, we will determine if one of our study questionnaires is routinely unfinished by the study participants. Reasons for this can be explored during the focus groups or one to one interviews. | Baseline | |
Primary | Number and percentage of participants who complete the study questionnaires | See outcome 5 | 4 weeks | |
Secondary | Change in severe Asthma Questionnaire (SAQ) mean 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 HRQoL scales but modified for the severe population and provides separate assessments of the effect of asthma symptoms and the effect of asthma medicines. The questionnaire has 16 items assessing experience over the last two weeks and was produced from detailed qualitative research. An additional 3 items are included to assess overall QoL during the last two weeks, and QoL during different months of the year. The 16 items are scored from 1 - 7 and the questions concerning overall Qol, best and worst months are scored using a 0 - 100 point scale. In all cases, a higher score indicates better quality of life. |
Change from baseline to post course (week 4) | |
Secondary | General Symptom Questionnaire (GSQ) | The GSQ is a 65 item questionnaire that was designed to measure the symptoms of patients with fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The questionnaire assesses the frequency of extra-pulmonary symptoms, such as somatic and psychological symptoms, on a 6 point Likert scale (the value scoring for each response shown in brackets): "Never or almost never" (1), "Less than 3 or 4 times per year" (2), "Every month or so" (3), "Every week or so" (4), "More than once per week" (5) or "Every day" (6). This questionnaire was used to measure the number and frequency of extra-pulmonary symptoms reported by patients. The scale measures frequency of symptoms with a higher score indicating greater symptom frequency and a worse outcome. This questionnaire be completed by potential participants at baseline to identify those that report 8 or more non-respiratory symptoms per week and are eligible to participate |
Pre-course (before enrollment on a BR course) | |
Secondary | Change in General Symptom Questionnaire-A score | This is an abridged General Symptom Questionnaires (GSQ) consisting of 16 non-respiratory symptoms that are associated with asthma severity. It uses the same 6 point Likert scale as the full GSQ with a higher score indicating a worse outcome. | Change from baseline to post course (week 4) | |
Secondary | Change in The Positive and Negative Affect Schedule (PANAS) score | This questionnaire measures positive and negative affect and consists 20 questions in total, 10 measuring positive affect and 10 measuring negative affect. Participants respond to each question by using a 5 point scale where 1 indicates "not at all" and 5 indicates "very much". A higher score for the first 10 questions indicates higher positive affect and a higher score for the next 10 questions indicates higher negative affect. | Change from baseline to post course (week 4) | |
Secondary | Change in the Asthma Control Questionnaire (ACQ) score | This questionnaire 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 questionnaire asks patients to assess their symptoms over the last week. | Change from baseline to post course (week 4) | |
Secondary | Global Rating of Change Questionnaire (GRCQ) | Phase one This scale will be used by participants to indicate how much better they feel since commencing a BR. The 11-point scale ranges from -5 (a great deal worse) to 5 (A great deal better) (15). The time scale is between before the start of treatment and the current assessment. Phase two In this phase of the study the GRCQ will be used by participants to indicate how much better they feel since commencing a BR and a biologic treatment they recently started. |
Post course (week 4) | |
Secondary | Friends and Family Test (FFT) | This is a one question questionnaire used throughout the NHS to assess a patient's thoughts on a health service they regularly use. The question we will use in the FFT asks "We would like you to think about your recent experience of our Body Reprogramming. How likely are you to recommend Body Reprogramming to friends and family if they needed a similar service? " Participants will respond on a 5 point scale from "Extremely Unlikely" to "Extremely Likely". | Post course (week 4) |
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