AsthmaLIBERTY-IDNCT06159803
LIving BEtteR With asThma - Intervention Development Study
An observational study of Asthma, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Approximately 330 million people in the world are living with asthma and 3-10% of them has difficult asthma that is challenging to control even with maximum doses of pharmacological treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Qualitative Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2024to 1 Nov 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The research population of interest for this study is people living with difficult asthma and health care and exercise professionals working with people with difficult asthma.
Who may be able to join
- Age 18 or over
- Must have had a diagnosis of difficult asthma
- Giving informed consent
- Aged 18 or over
- Healthcare professional or exercise professional with experience of working with people living
- with difficult asthma
- Giving informed consent
Who cannot join
- Less than 18 years old
- Does not have a diagnosis of difficult asthma
- Unwilling or unable to give informed consent
- Unwilling or unable to participate in the interview
- Participation in the LIBERTY pilot study
- Less than 18 years old
Show all 10Show fewer
- Not a healthcare professional or exercise professional
- Not having experience of working with people living with difficult asthma
- Unwilling or unable to give informed consent
- Unwilling or unable to participate in the interview
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Judit Varkonyi-Sepp
Southampton, Hampshire, SO166YD
Judit Varkonyi-Sepp, Chief Investigator, +44 023 8120 6315, j.varkonyi-sepp@soton.ac.uk
Anna Freeman, Dr
About this study
Approximately 330 million people in the world are living with asthma and 3-10% of them has difficult asthma that is challenging to control even with maximum doses of pharmacological treatment. In the last five years our multidisciplinary team has shown the clinical benefits of a short-term structured exercise programme for people living with difficult asthma (PDA) (1). However, engaging PDA in self-maintained exercise long-term and outside of the hospital environment remains a challenge. Changing and maintaining behaviours requires complex psychological and cognitive processes and appropriate modes of support by skilled practitioners. Underpinned by behavioural science and health psychology principles, our team has developed a world renown multimodal self-management support intervention for people living with cancer (2). The intervention focuses on initiating and maintaining exercise, optimising diet and includes supporting people through the cognitive and psychological processes to change their behaviour. We aim to adapt this intervention for PDA to optimise their self-management via the LIBERTY study. To achieve the best outcomes, prior to commencing the LIBERTY study, we aim to develop the intervention using the acclaimed Person-Based Approach (PBA) (3). This methodology is considered gold standard in behaviour change intervention development, implementation and evaluation and maximise the probability of the uptake and maintenance of the desired behaviour.
Read the detailed description
The burden of poor asthma control remains high in the United Kingdom (UK). Given high asthma prevalence, poor asthma control exerts significant impact at individual and societal levels and accounts for one fifth of the total chronic respiratory disability-adjusted life year burden (4). 'Remission' or well-controlled asthma requires continuation of regular medical treatment, sustained adherence to medications and other self-management behaviours (e.g. healthy diet, avoiding triggers, physical activity), and exposure to risk of potential medication side effects with plus ongoing financial implications. 3-10% of people living with asthma has difficult asthma, defined as asthma that is uncontrolled despite GINA (Global Initiative for Asthma) Step 4 or 5 treatment (5) or requires such treatment to maintain good control and reduce exacerbations. It is increasingly recognised that problematic difficult asthma is a multidimensional state comprising numerous treatable traits that merit targeted approaches (6). This multimorbid disease framework (defined as the coexistence of >2 health conditions) is particularly prevalent in difficult asthma and represents a complex constellation of conditions that collectively impose a significant burden on the patient (7) These treatable traits can be pulmonary, extrapulmonary and behavioural (7). Treatable traits, including obesity, anxiety and depression, dysfunctional breathing and inactivity predict future exacerbation risk in difficult asthma, and so addressing these should be a key part of asthma management for both individual patient benefit and health economic reasons (8). Multimodal non-pharmacological approaches are needed to do that but there is limited understanding of their role in difficult asthma to guide their use.
- Conditions
- Asthma
- Being tested
- Qualitative Interview
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative InterviewBehavioural
One-to-one semi-structured interviews and Think Aloud interviews
| Study group | Role | What they receive |
|---|---|---|
| Patient | Adult patients with difficult asthma:
1. To carry out semi-structured interviews with PDA to explore their experiences, beliefs and attitudes to exercise, diet and emotional self-management support.
2. To carry out semi-structured interviews with PDA that explores the barriers and facilitators to key behaviours that will be targeted in the intervention.
3. To carry out iterative think aloud with PDA to elicit feedback on drafts of the intervention to optimise the intervention. Receives: Behavioral: Qualitative Interview | |
| NHS professionals/Exercise professionals | NHS professionals working with people living with difficult asthma:
Exercise professionals working with people living with difficult asthma:
1. To carry out semi-structured interviews with health care and exercise professionals who work with patients living with severe asthma to explore their experiences, beliefs and attitudes to providing exercise, diet and emotional self-management support to this patient group
2. To carry out semi-structured interviews with health care and exercise professionals who work with patients living with severe asthma that explores the barriers and facilitators to key components that are planned to be included in the intervention.
3. To carry out iterative think aloud with health care and exercise professionals who work with patients living with severe asthma to elicit feedback on drafts of the intervention to optimise the intervention Receives: Behavioral: Qualitative Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative interviews
Experiences, preferences and perceived barriers to support for exercise, diet and emotional self-management of people living with asthma and professionals working with people living with asthma
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start19 Apr 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159803
- Sponsor's protocol ID
- RHM MED2028
- Acronym
- LIBERTY-ID
- Status last verified
- Apr 2024
- First submitted
- 17 Oct 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freeman A, Cellura D, Minnion M, Fernandez BO, Spalluto CM, Levett D, Bates A, Wallis T, Watson A, Jack S, Staples KJ, Grocott MPW, Feelisch M, Wilkinson TMA. Exercise Training Induces a Shift in Extracellular Redox Status with Alterations in the Pulmonary and Systemic Redox Landscape in Asthma. Antioxidants (Basel). 2021 Nov 30;10(12):1926. doi: 10.3390/antiox10121926.
PubMed 34943027Grimmett C, Bates A, West M, Leggett S, Varkonyi-Sepp J, Campbell A, Davis J, Wootton S, Shaw C, Barlow R, Ashcroft J, Scott A, Moyes H, Hawkins L, Levett DZH, Williams F, Grocott MPW, Jack S. SafeFit Trial: virtual clinics to deliver a multimodal intervention to improve psychological and physical well-being in people with cancer. Protocol of a COVID-19 targeted non-randomised phase III trial. BMJ Open. 2021 Aug 26;11(8):e048175. doi: 10.1136/bmjopen-2020-048175.
PubMed 34446487Yardley L, Morrison L, Bradbury K, Muller I. The person-based approach to intervention development: application to digital health-related behavior change interventions. J Med Internet Res. 2015 Jan 30;17(1):e30. doi: 10.2196/jmir.4055.
PubMed 25639757GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
PubMed 33069326Tay TR, Hew M. Comorbid "treatable traits" in difficult asthma: Current evidence and clinical evaluation. Allergy. 2018 Jul;73(7):1369-1382. doi: 10.1111/all.13370. Epub 2017 Dec 15.
PubMed 29178130McDonald VM, Hiles SA, Godbout K, Harvey ES, Marks GB, Hew M, Peters M, Bardin PG, Reynolds PN, Upham JW, Baraket M, Bhikoo Z, Bowden J, Brockway B, Chung LP, Cochrane B, Foxley G, Garrett J, Jayaram L, Jenkins C, Katelaris C, Katsoulotos G, Koh MS, Kritikos V, Lambert M, Langton D, Lara Rivero A, Middleton PG, Nanguzgambo A, Radhakrishna N, Reddel H, Rimmer J, Southcott AM, Sutherland M, Thien F, Wark PAB, Yang IA, Yap E, Gibson PG. Treatable traits can be identified in a severe asthma registry and predict future exacerbations. Respirology. 2019 Jan;24(1):37-47. doi: 10.1111/resp.13389. Epub 2018 Sep 19.
PubMed 30230137Hansen ESH, Pitzner-Fabricius A, Toennesen LL, Rasmusen HK, Hostrup M, Hellsten Y, Backer V, Henriksen M. Effect of aerobic exercise training on asthma in adults: a systematic review and meta-analysis. Eur Respir J. 2020 Jul 30;56(1):2000146. doi: 10.1183/13993003.00146-2020. Print 2020 Jul.
PubMed 32350100Freitas PD, Ferreira PG, Silva AG, Stelmach R, Carvalho-Pinto RM, Fernandes FL, Mancini MC, Sato MN, Martins MA, Carvalho CR. The Role of Exercise in a Weight-Loss Program on Clinical Control in Obese Adults with Asthma. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Jan 1;195(1):32-42. doi: 10.1164/rccm.201603-0446OC.
PubMed 27744739Paolucci EM, Loukov D, Bowdish DME, Heisz JJ. Exercise reduces depression and inflammation but intensity matters. Biol Psychol. 2018 Mar;133:79-84. doi: 10.1016/j.biopsycho.2018.01.015. Epub 2018 Feb 3.
PubMed 29408464Cordova-Rivera L, Gibson PG, Gardiner PA, McDonald VM. A Systematic Review of Associations of Physical Activity and Sedentary Time with Asthma Outcomes. J Allergy Clin Immunol Pract. 2018 Nov-Dec;6(6):1968-1981.e2. doi: 10.1016/j.jaip.2018.02.027. Epub 2018 Mar 3.
PubMed 29510231Garcia-Aymerich J, Varraso R, Anto JM, Camargo CA Jr. Prospective study of physical activity and risk of asthma exacerbations in older women. Am J Respir Crit Care Med. 2009 Jun 1;179(11):999-1003. doi: 10.1164/rccm.200812-1929OC. Epub 2009 Feb 26.
PubMed 19246716Freeman AT, Hill D, Newell C, Moyses H, Azim A, Knight D, Presland L, Harvey M, Haitchi HM, Watson A, Staples KJ, Kurukulaaratchy RJ, Wilkinson TMA. Patient perceived barriers to exercise and their clinical associations in difficult asthma. Asthma Res Pract. 2020 Jun 9;6:5. doi: 10.1186/s40733-020-00058-6. eCollection 2020.
PubMed 32537235Azim A, Freeman A, Lavenu A, Mistry H, Haitchi HM, Newell C, Cheng Y, Thirlwall Y, Harvey M, Barber C, Pontoppidan K, Dennison P, Arshad SH, Djukanovic R, Howarth P, Kurukulaaratchy RJ. New Perspectives on Difficult Asthma; Sex and Age of Asthma-Onset Based Phenotypes. J Allergy Clin Immunol Pract. 2020 Nov-Dec;8(10):3396-3406.e4. doi: 10.1016/j.jaip.2020.05.053. Epub 2020 Jun 13.
PubMed 32544545Varkonyi-Sepp J, Freeman A, Ainsworth B, Kadalayil LP, Haitchi HM, Kurukulaaratchy RJ. Multimorbidity in Difficult Asthma: The Need for Personalised and Non-Pharmacological Approaches to Address a Difficult Breathing Syndrome. J Pers Med. 2022 Aug 31;12(9):1435. doi: 10.3390/jpm12091435.
PubMed 36143220Morrison L, Muller I, Yardley L, Bradbury K. The person-based approach to planning, optimising, evaluating and implementing behavioural health interventions. The European Health Psychologist. 2018;20(3):464-9
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIving BEtteR With asThma - Intervention Development Study
- ClinicalTrials.gov ID
- NCT06159803
- Acronym / sponsor ID
- LIBERTY-ID / RHM MED2028
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 19 Apr 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 7 Dec 2023 (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.
Approximately 330 million people in the world are living with asthma and 3-10% of them has difficult asthma that is challenging to control even with maximum doses of pharmacological treatment. In the last five years our multidisciplinary team has shown the clinical benefits of a short-term structured exercise programme for people living with difficult asthma (PDA) (1). However, engaging PDA in self-maintained exercise long-term and outside of the hospital environment remains a challenge. Changing and maintaining behaviours requires complex psychological and cognitive processes and appropriate modes of support by skilled practitioners. Underpinned by behavioural science and health psychology principles, our team has developed a world renown multimodal self-management support intervention for people living with cancer (2). The intervention focuses on initiating and maintaining exercise, optimising diet and includes supporting people through the cognitive and psychological processes to change their behaviour. We aim to adapt this intervention for PDA to optimise their self-management via the LIBERTY study. To achieve the best outcomes, prior to commencing the LIBERTY study, we aim to develop the intervention using the acclaimed Person-Based Approach (PBA) (3). This methodology is considered gold standard in behaviour change intervention development, implementation and evaluation and maximise the probability of the uptake and maintenance of the desired behaviour.
Detailed description
The burden of poor asthma control remains high in the United Kingdom (UK). Given high asthma prevalence, poor asthma control exerts significant impact at individual and societal levels and accounts for one fifth of the total chronic respiratory disability-adjusted life year burden (4). 'Remission' or well-controlled asthma requires continuation of regular medical treatment, sustained adherence to medications and other self-management behaviours (e.g. healthy diet, avoiding triggers, physical activity), and exposure to risk of potential medication side effects with plus ongoing financial implications. 3-10% of people living with asthma has difficult asthma, defined as asthma that is uncontrolled despite GINA (Global Initiative for Asthma) Step 4 or 5 treatment (5) or requires such treatment to maintain good control and reduce exacerbations. It is increasingly recognised that problematic difficult asthma is a multidimensional state comprising numerous treatable traits that merit targeted approaches (6). This multimorbid disease framework (defined as the coexistence of >2 health conditions) is particularly prevalent in difficult asthma and represents a complex constellation of conditions that collectively impose a significant burden on the patient (7) These treatable traits can be pulmonary, extrapulmonary and behavioural (7). Treatable traits, including obesity, anxiety and depression, dysfunctional breathing and inactivity predict future exacerbation risk in difficult asthma, and so addressing these should be a key part of asthma management for both individual patient benefit and health economic reasons (8). Multimodal non-pharmacological approaches are needed to do that but there is limited understanding of their role in difficult asthma to guide their use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Behavioral: Qualitative InterviewAdult patients with difficult asthma: 1. To carry out semi-structured interviews with PDA to explore their experiences, beliefs and attitudes to exercise, diet and emotional self-management support. 2. To carry out semi-structured interviews with PDA that explores the barriers and facilitators to key behaviours that will be targeted in the intervention. 3. To carry out iterative think aloud with PDA to elicit feedback on drafts of the intervention to optimise the intervention. |
| NHS professionals/Exercise professionals | – | Behavioral: Qualitative InterviewNHS professionals working with people living with difficult asthma: Exercise professionals working with people living with difficult asthma: 1. To carry out semi-structured interviews with health care and exercise professionals who work with patients living with severe asthma to explore their experiences, beliefs and attitudes to providing exercise, diet and emotional self-management support to this patient group 2. To carry out semi-structured interviews with health care and exercise professionals who work with patients living with severe asthma that explores the barriers and facilitators to key components that are planned to be included in the intervention. 3. To carry out iterative think aloud with health care and exercise professionals who work with patients living with severe asthma to elicit feedback on drafts of the intervention to optimise the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The research population of interest for this study is people living with difficult asthma and health care and exercise professionals working with people with difficult asthma.
Key inclusion criteria (7 listed)
- Age 18 or over
- Must have had a diagnosis of difficult asthma
- Giving informed consent
- Aged 18 or over
- Healthcare professional or exercise professional with experience of working with people living
Key exclusion criteria (10 listed)
- Less than 18 years old
- Does not have a diagnosis of difficult asthma
- Unwilling or unable to give informed consent
- Unwilling or unable to participate in the interview
- Participation in the LIBERTY pilot study
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 |
|---|---|---|
| Qualitative InterviewOne-to-one semi-structured interviews and Think Aloud interviews | Behavioural | NHS professionals/Exercise professionals, Patient |
Primary outcome
Qualitative interviews
Time frame: 24 months
Experiences, preferences and perceived barriers to support for exercise, diet and emotional self-management of people living with asthma and professionals working with people living with asthma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 34943027Freeman A, Cellura D, Minnion M, Fernandez BO, Spalluto CM, Levett D, Bates A, Wallis T, Watson A, Jack S, Staples KJ, Grocott MPW, Feelisch M, Wilkinson TMA. Exercise Training Induces a Shift in Extracellular Redox Status with Alterations in the Pulmonary and Systemic Redox Landscape in Asthma. Antioxidants (Basel). 2021 Nov 30;10(12):1926. doi: 10.3390/antiox10121926.
- Background: PubMed 34446487Grimmett C, Bates A, West M, Leggett S, Varkonyi-Sepp J, Campbell A, Davis J, Wootton S, Shaw C, Barlow R, Ashcroft J, Scott A, Moyes H, Hawkins L, Levett DZH, Williams F, Grocott MPW, Jack S. SafeFit Trial: virtual clinics to deliver a multimodal intervention to improve psychological and physical well-being in people with cancer. Protocol of a COVID-19 targeted non-randomised phase III trial. BMJ Open. 2021 Aug 26;11(8):e048175. doi: 10.1136/bmjopen-2020-048175.
- Background: PubMed 25639757Yardley L, Morrison L, Bradbury K, Muller I. The person-based approach to intervention development: application to digital health-related behavior change interventions. J Med Internet Res. 2015 Jan 30;17(1):e30. doi: 10.2196/jmir.4055.
- Background: PubMed 33069326GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
- Background: PubMed 29178130Tay TR, Hew M. Comorbid "treatable traits" in difficult asthma: Current evidence and clinical evaluation. Allergy. 2018 Jul;73(7):1369-1382. doi: 10.1111/all.13370. Epub 2017 Dec 15.
- Background: PubMed 30230137McDonald VM, Hiles SA, Godbout K, Harvey ES, Marks GB, Hew M, Peters M, Bardin PG, Reynolds PN, Upham JW, Baraket M, Bhikoo Z, Bowden J, Brockway B, Chung LP, Cochrane B, Foxley G, Garrett J, Jayaram L, Jenkins C, Katelaris C, Katsoulotos G, Koh MS, Kritikos V, Lambert M, Langton D, Lara Rivero A, Middleton PG, Nanguzgambo A, Radhakrishna N, Reddel H, Rimmer J, Southcott AM, Sutherland M, Thien F, Wark PAB, Yang IA, Yap E, Gibson PG. Treatable traits can be identified in a severe asthma registry and predict future exacerbations. Respirology. 2019 Jan;24(1):37-47. doi: 10.1111/resp.13389. Epub 2018 Sep 19.
- Background: PubMed 32350100Hansen ESH, Pitzner-Fabricius A, Toennesen LL, Rasmusen HK, Hostrup M, Hellsten Y, Backer V, Henriksen M. Effect of aerobic exercise training on asthma in adults: a systematic review and meta-analysis. Eur Respir J. 2020 Jul 30;56(1):2000146. doi: 10.1183/13993003.00146-2020. Print 2020 Jul.
- Background: PubMed 27744739Freitas PD, Ferreira PG, Silva AG, Stelmach R, Carvalho-Pinto RM, Fernandes FL, Mancini MC, Sato MN, Martins MA, Carvalho CR. The Role of Exercise in a Weight-Loss Program on Clinical Control in Obese Adults with Asthma. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Jan 1;195(1):32-42. doi: 10.1164/rccm.201603-0446OC.
- Background: PubMed 29408464Paolucci EM, Loukov D, Bowdish DME, Heisz JJ. Exercise reduces depression and inflammation but intensity matters. Biol Psychol. 2018 Mar;133:79-84. doi: 10.1016/j.biopsycho.2018.01.015. Epub 2018 Feb 3.
- Background: PubMed 29510231Cordova-Rivera L, Gibson PG, Gardiner PA, McDonald VM. A Systematic Review of Associations of Physical Activity and Sedentary Time with Asthma Outcomes. J Allergy Clin Immunol Pract. 2018 Nov-Dec;6(6):1968-1981.e2. doi: 10.1016/j.jaip.2018.02.027. Epub 2018 Mar 3.
- Background: PubMed 19246716Garcia-Aymerich J, Varraso R, Anto JM, Camargo CA Jr. Prospective study of physical activity and risk of asthma exacerbations in older women. Am J Respir Crit Care Med. 2009 Jun 1;179(11):999-1003. doi: 10.1164/rccm.200812-1929OC. Epub 2009 Feb 26.
- Background: PubMed 32537235Freeman AT, Hill D, Newell C, Moyses H, Azim A, Knight D, Presland L, Harvey M, Haitchi HM, Watson A, Staples KJ, Kurukulaaratchy RJ, Wilkinson TMA. Patient perceived barriers to exercise and their clinical associations in difficult asthma. Asthma Res Pract. 2020 Jun 9;6:5. doi: 10.1186/s40733-020-00058-6. eCollection 2020.
- Asthma GIf. Global Strategy for Asthma Management and Prevention 2021Link provided by the sponsor.
- Braun V, Clarke V. Using thematic analysis in psychology Using thematic analysis in psychology. Qual Res Psychol \[Internet\]. 206AD;3:77-101Link provided by the sponsor.
- HRA guidanceLink provided by the sponsor.
- ICMJE - Roles and Responsibilities of Authors, Contributors, Reviewers, Editors, Publishers, and OwnersLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
RecruitingObservational study
Swiss Severe Asthma Register
Severe Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
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.
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 University Hospital Southampton NHS Foundation Trust at 1 site 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Freeman (02381206397, a.freeman@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative interviews (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159803, which also lists 16 linked publications.
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 17 Apr 2024.