AsthmaWATCHNCT03996590
Wessex Asthma Cohort of Difficult Asthma
An observational study of Asthma, run by University Hospital Southampton NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
Asthma is now widely recognised to be a heterogeneous disease. The last two decades have seen the identification of a number of biological targets and development of various novel therapies. Despite this, asthma still represents a significant health and economic burden worldwide. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma
- How many people
- 566 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 22 Apr 2015to Dec 2050
- How long will I take part?
- 35 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe or difficult asthma referred to secondary and tertiary referral centres
Who may be able to join
- All patients referred to the Adult or Transitional Regional Asthma Clinics at participating hospitals.
- On high-dose therapies, with or without the addition of continuous or frequent use of oral steroids (or steroid sparing therapies), as defined by the BTS (British Thoracic Society) Adult Asthma Management Guidelines (2016).
Who cannot join
- Asthma patients who are not referred to the Adult or Transitional Regional Asthma Clinics at participating hospitals.
- Any patients who are not on high-dose therapies, with or without the addition of continuous or frequent use of oral steroids (or steroid sparing therapies), as per the BTS (British Thoracic Society) Adult Asthma Management Guidelines (2016).
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Isle of Wight NHS Trust
Newport, Isle Of Wight, PO30 5TG
Portsmouth Hospitals NHS Trust
Portsmouth, Hamsphire, PO6 3LY
University Hospital Southampton NHS Foundation Trust
Southampton, Hamsphire, SO16 6YD
About this study
Official title: WATCH (Wessex AsThma CoHort of Difficult Asthma): A Longitudinal Cohort Study to Facilitate Better Understanding and Management of Difficult Asthma Encountered in Clinical Practice
Asthma is now widely recognised to be a heterogeneous disease. The last two decades have seen the identification of a number of biological targets and development of various novel therapies. Despite this, asthma still represents a significant health and economic burden worldwide. Why some individuals should continue to suffer remains unclear.
The Wessex Asthma Cohort of Difficult Asthma (WATCH) is an ongoing 'real-life', prospective study of patients in the University Hospital Southampton Foundation Trust (UHSFT) Difficult Asthma service. Research data capture is aligned with the extensive clinical characterisation required of a commissioned National Health Service (NHS) Specialist Centre for Severe Asthma. Data acquisition includes detailed clinical, health and disease-related questionnaires, anthropometry, allergy and lung function testing, radiological imaging (in a small subset) and collection of biological samples (blood, urine and sputum). Prospective data are captured in parallel to clinical follow up appointments, with data entered into a bespoke database.
The pragmatic ongoing nature of the WATCH study allows comprehensive assessment of the real world clinical spectrum seen in a Specialist Asthma Centre and allows a longitudinal perspective of deeply phenotyped patients. It is anticipated that the WATCH cohort would act as a vehicle for potential collaborative asthma studies and will build upon our understanding of mechanisms underlying difficult asthma.
Read the detailed description
Asthma is estimated to affect 5.2 million people in the United Kingdom (UK), half of whom experience severe symptoms at some point in their lives, and 500,000 of whom may be unresponsive to currently available therapies (Asthma UK; "living on a knife edge" 2004). Severe Asthma probably accounts for 80% of asthma-related health expenditure (Chung KF, Eur Res Mon 2003, 23: 313). In this regard it is estimated to directly cost the NHS (National Health Service) £1 billion per year but also poses considerable hidden societal costs through disability, missed schooling and lost work days.
While Severe Asthma is a significant health-economic problem, the availability of effective treatments in clinical practice remains limited. However there is a growing realisation of the heterogeneity of asthma, which is not a single condition, but composed of numerous potential phenotypes (Wenzel S Nat Med 2012 18(5):716-25) some of which may show association to more severe disease status. In this regard recent adoption of unbiased statistical techniques such as cluster analysis has consistently demonstrated presence of severe asthma clusters in both adult and paediatric populations. These clinical phenotypes may show specific pathophysiological associations leading to classification of endotypes. Accompanying this growing understanding of the diverse nature of asthma is the realisation that there are also a diverse range of treatment responses dependent on the underlying nature of an individual's disease. This naturally leads to the concept of personalised therapy regimes for patients with Severe Asthma that better target their individual disease. Omalizumab is the first biological asthma treatment to meet that need in patients with severe allergic asthma. Numerous potential biological agents are in development that show promise in targeting patients with particular disease phenotypes/ endotypes such as mepolizumab, lebrikizumab and dupilimumab.
The organisation of Clinical Services for Severe Asthma is undergoing major change with the initiation of Specialised Commissioning of such Services by NHS England in 2014. A core requirement for Specialist Centres being Commissioned under this process will be the maintenance of accurate clinical disease registers which link to the BTS Difficult Asthma Registry and support collaborative research studies in the future.
The Difficult Asthma Clinics at Southampton and Portsmouth currently care for 1000 and 400 patients with problematic disease respectively. The two asthma services already collaborate as the Wessex Asthma Network to provide education across the Wessex region. Both services in their roles as Commissioned Specialist Clinical Centre for Severe Asthma receive regional referrals from a wide geographical area. We intend to initiate a comprehensively assessed Difficult Asthma Cohort by inviting all patients in our clinics to participate and contribute data gained through their clinical assessment. This would support ongoing contribution to research via the BTS Difficult Asthma Registry. In addition, a real-life clinical characterisation of Difficult Asthma would provide the basis for a better understanding of the nature of that disease relevant to clinical practice. It would also provide opportunity to develop a better endotype defined understanding of Difficult Asthma that facilitates stratified development of more effective treatment strategies. The Cohort will become a resource for future therapeutic studies in Difficult Asthma with Cohort participants being invited to consent separately into those studies based upon their characterisation through the Cohort.
- Conditions
- Asthma
- Keywords
- Difficult Asthma, Severe Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort Characterisation
To develop a phenotypic characterisation of the heterogeneous nature of severe asthma seen in clinical practice that reflects disease natural history and treatment intervention responsiveness
Measured: 35 years
Secondary outcomes (2)
Clinical Endotyping
To relate well characterised clinical disease phenotypes to pathophysiological endotypes of severe asthma.
Measured: 35 years
Patient Stratification
To enable accurate stratification of patients for trials of novel pharmacological and non-pharmacological treatment strategies that facilitates an era of individualised patient management.
Measured: 35 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start22 Apr 2015
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- 566 participants (actual)
- Target duration
- 35 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Boehringer Ingelheim, National Institutes of Health (NIH), Owlstone Ltd, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Ramesh J Kurukulaaratchy, DM FRCP, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996590
- Sponsor's protocol ID
- RHM MED1216
- Acronym
- WATCH
- Status last verified
- Jan 2024
- First submitted
- 20 Jun 2019
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith DH, Malone DC, Lawson KA, Okamoto LJ, Battista C, Saunders WB. A national estimate of the economic costs of asthma. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):787-93. doi: 10.1164/ajrccm.156.3.9611072.
PubMed 9309994Barnes PJ, Jonsson B, Klim JB. The costs of asthma. Eur Respir J. 1996 Apr;9(4):636-42. doi: 10.1183/09031936.96.09040636.
PubMed 8726924Masoli M, Fabian D, Holt S, Beasley R; Global Initiative for Asthma (GINA) Program. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004 May;59(5):469-78. doi: 10.1111/j.1398-9995.2004.00526.x. No abstract available.
PubMed 15080825Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012 May 4;18(5):716-25. doi: 10.1038/nm.2678.
PubMed 22561835Moore WC, Meyers DA, Wenzel SE, Teague WG, Li H, Li X, D'Agostino R Jr, Castro M, Curran-Everett D, Fitzpatrick AM, Gaston B, Jarjour NN, Sorkness R, Calhoun WJ, Chung KF, Comhair SA, Dweik RA, Israel E, Peters SP, Busse WW, Erzurum SC, Bleecker ER; National Heart, Lung, and Blood Institute's Severe Asthma Research Program. Identification of asthma phenotypes using cluster analysis in the Severe Asthma Research Program. Am J Respir Crit Care Med. 2010 Feb 15;181(4):315-23. doi: 10.1164/rccm.200906-0896OC. Epub 2009 Nov 5.
PubMed 19892860Haldar P, Pavord ID, Shaw DE, Berry MA, Thomas M, Brightling CE, Wardlaw AJ, Green RH. Cluster analysis and clinical asthma phenotypes. Am J Respir Crit Care Med. 2008 Aug 1;178(3):218-224. doi: 10.1164/rccm.200711-1754OC. Epub 2008 May 14.
PubMed 18480428Weatherall M, Travers J, Shirtcliffe PM, Marsh SE, Williams MV, Nowitz MR, Aldington S, Beasley R. Distinct clinical phenotypes of airways disease defined by cluster analysis. Eur Respir J. 2009 Oct;34(4):812-8. doi: 10.1183/09031936.00174408. Epub 2009 Apr 8.
PubMed 19357143Fitzpatrick AM, Teague WG, Meyers DA, Peters SP, Li X, Li H, Wenzel SE, Aujla S, Castro M, Bacharier LB, Gaston BM, Bleecker ER, Moore WC; National Institutes of Health/National Heart, Lung, and Blood Institute Severe Asthma Research Program. Heterogeneity of severe asthma in childhood: confirmation by cluster analysis of children in the National Institutes of Health/National Heart, Lung, and Blood Institute Severe Asthma Research Program. J Allergy Clin Immunol. 2011 Feb;127(2):382-389.e1-13. doi: 10.1016/j.jaci.2010.11.015. Epub 2010 Dec 31.
PubMed 21195471Just J, Gouvis-Echraghi R, Rouve S, Wanin S, Moreau D, Annesi-Maesano I. Two novel, severe asthma phenotypes identified during childhood using a clustering approach. Eur Respir J. 2012 Jul;40(1):55-60. doi: 10.1183/09031936.00123411. Epub 2012 Jan 20.
PubMed 22267763Lotvall J, Akdis CA, Bacharier LB, Bjermer L, Casale TB, Custovic A, Lemanske RF Jr, Wardlaw AJ, Wenzel SE, Greenberger PA. Asthma endotypes: a new approach to classification of disease entities within the asthma syndrome. J Allergy Clin Immunol. 2011 Feb;127(2):355-60. doi: 10.1016/j.jaci.2010.11.037.
PubMed 21281866Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.
PubMed 22901886Corren J, Lemanske RF, Hanania NA, Korenblat PE, Parsey MV, Arron JR, Harris JM, Scheerens H, Wu LC, Su Z, Mosesova S, Eisner MD, Bohen SP, Matthews JG. Lebrikizumab treatment in adults with asthma. N Engl J Med. 2011 Sep 22;365(12):1088-98. doi: 10.1056/NEJMoa1106469. Epub 2011 Aug 3.
PubMed 21812663Wenzel S, Ford L, Pearlman D, Spector S, Sher L, Skobieranda F, Wang L, Kirkesseli S, Rocklin R, Bock B, Hamilton J, Ming JE, Radin A, Stahl N, Yancopoulos GD, Graham N, Pirozzi G. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013 Jun 27;368(26):2455-66. doi: 10.1056/NEJMoa1304048. Epub 2013 May 21.
PubMed 23688323Mistry H, Ajsivinac Soberanis HM, Kyyaly MA, Azim A, Barber C, Knight D, Newell C, Haitchi HM, Wilkinson T, Howarth P, Seumois G, Vijayanand P, Arshad SH, Kurukulaaratchy RJ. The Clinical Implications of Aspergillus Fumigatus Sensitization in Difficult-To-Treat Asthma Patients. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4254-4267.e10. doi: 10.1016/j.jaip.2021.08.038. Epub 2021 Sep 14.
PubMed 34534722
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WATCH (Wessex AsThma CoHort of Difficult Asthma): A Longitudinal Cohort Study to Facilitate Better Understanding and Management of Difficult Asthma Encountered in Clinical Practice
- ClinicalTrials.gov ID
- NCT03996590
- Acronym / sponsor ID
- WATCH / RHM MED1216
- Conditions
- Asthma
- Keywords
- Difficult Asthma, Severe Asthma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 566 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Novartis, Boehringer Ingelheim, National Institutes of Health (NIH), Owlstone Ltd, National Institute for Health Research, United Kingdom
- Study start
- 22 Apr 2015 (actual)
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 25 Jun 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.
Asthma is now widely recognised to be a heterogeneous disease. The last two decades have seen the identification of a number of biological targets and development of various novel therapies. Despite this, asthma still represents a significant health and economic burden worldwide. Why some individuals should continue to suffer remains unclear.
The Wessex Asthma Cohort of Difficult Asthma (WATCH) is an ongoing 'real-life', prospective study of patients in the University Hospital Southampton Foundation Trust (UHSFT) Difficult Asthma service. Research data capture is aligned with the extensive clinical characterisation required of a commissioned National Health Service (NHS) Specialist Centre for Severe Asthma. Data acquisition includes detailed clinical, health and disease-related questionnaires, anthropometry, allergy and lung function testing, radiological imaging (in a small subset) and collection of biological samples (blood, urine and sputum). Prospective data are captured in parallel to clinical follow up appointments, with data entered into a bespoke database.
The pragmatic ongoing nature of the WATCH study allows comprehensive assessment of the real world clinical spectrum seen in a Specialist Asthma Centre and allows a longitudinal perspective of deeply phenotyped patients. It is anticipated that the WATCH cohort would act as a vehicle for potential collaborative asthma studies and will build upon our understanding of mechanisms underlying difficult asthma.
Detailed description
Asthma is estimated to affect 5.2 million people in the United Kingdom (UK), half of whom experience severe symptoms at some point in their lives, and 500,000 of whom may be unresponsive to currently available therapies (Asthma UK; "living on a knife edge" 2004). Severe Asthma probably accounts for 80% of asthma-related health expenditure (Chung KF, Eur Res Mon 2003, 23: 313). In this regard it is estimated to directly cost the NHS (National Health Service) £1 billion per year but also poses considerable hidden societal costs through disability, missed schooling and lost work days.
While Severe Asthma is a significant health-economic problem, the availability of effective treatments in clinical practice remains limited. However there is a growing realisation of the heterogeneity of asthma, which is not a single condition, but composed of numerous potential phenotypes (Wenzel S Nat Med 2012 18(5):716-25) some of which may show association to more severe disease status. In this regard recent adoption of unbiased statistical techniques such as cluster analysis has consistently demonstrated presence of severe asthma clusters in both adult and paediatric populations. These clinical phenotypes may show specific pathophysiological associations leading to classification of endotypes. Accompanying this growing understanding of the diverse nature of asthma is the realisation that there are also a diverse range of treatment responses dependent on the underlying nature of an individual's disease. This naturally leads to the concept of personalised therapy regimes for patients with Severe Asthma that better target their individual disease. Omalizumab is the first biological asthma treatment to meet that need in patients with severe allergic asthma. Numerous potential biological agents are in development that show promise in targeting patients with particular disease phenotypes/ endotypes such as mepolizumab, lebrikizumab and dupilimumab.
The organisation of Clinical Services for Severe Asthma is undergoing major change with the initiation of Specialised Commissioning of such Services by NHS England in 2014. A core requirement for Specialist Centres being Commissioned under this process will be the maintenance of accurate clinical disease registers which link to the BTS Difficult Asthma Registry and support collaborative research studies in the future.
The Difficult Asthma Clinics at Southampton and Portsmouth currently care for 1000 and 400 patients with problematic disease respectively. The two asthma services already collaborate as the Wessex Asthma Network to provide education across the Wessex region. Both services in their roles as Commissioned Specialist Clinical Centre for Severe Asthma receive regional referrals from a wide geographical area. We intend to initiate a comprehensively assessed Difficult Asthma Cohort by inviting all patients in our clinics to participate and contribute data gained through their clinical assessment. This would support ongoing contribution to research via the BTS Difficult Asthma Registry. In addition, a real-life clinical characterisation of Difficult Asthma would provide the basis for a better understanding of the nature of that disease relevant to clinical practice. It would also provide opportunity to develop a better endotype defined understanding of Difficult Asthma that facilitates stratified development of more effective treatment strategies. The Cohort will become a resource for future therapeutic studies in Difficult Asthma with Cohort participants being invited to consent separately into those studies based upon their characterisation through the Cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 35 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe or difficult asthma referred to secondary and tertiary referral centres
Key inclusion criteria (2 listed)
- All patients referred to the Adult or Transitional Regional Asthma Clinics at participating hospitals.
- On high-dose therapies, with or without the addition of continuous or frequent use of oral steroids (or steroid sparing therapies), as defined by the BTS (British Thoracic Society) Adult Asthma Management Guidelines (2016).
Key exclusion criteria (2 listed)
- Asthma patients who are not referred to the Adult or Transitional Regional Asthma Clinics at participating hospitals.
- Any patients who are not on high-dose therapies, with or without the addition of continuous or frequent use of oral steroids (or steroid sparing therapies), as per the BTS (British Thoracic Society) Adult Asthma Management Guidelines (2016).
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
Cohort Characterisation
Time frame: 35 years
To develop a phenotypic characterisation of the heterogeneous nature of severe asthma seen in clinical practice that reflects disease natural history and treatment intervention responsiveness
2 secondary outcomes
Clinical Endotyping
Time frame: 35 years
Patient Stratification
Time frame: 35 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Background: PubMed 9309994Smith DH, Malone DC, Lawson KA, Okamoto LJ, Battista C, Saunders WB. A national estimate of the economic costs of asthma. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):787-93. doi: 10.1164/ajrccm.156.3.9611072.
- Background: PubMed 8726924Barnes PJ, Jonsson B, Klim JB. The costs of asthma. Eur Respir J. 1996 Apr;9(4):636-42. doi: 10.1183/09031936.96.09040636.
- Background: PubMed 15080825Masoli M, Fabian D, Holt S, Beasley R; Global Initiative for Asthma (GINA) Program. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004 May;59(5):469-78. doi: 10.1111/j.1398-9995.2004.00526.x. No abstract available.
- Background: PubMed 22561835Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012 May 4;18(5):716-25. doi: 10.1038/nm.2678.
- Background: PubMed 19892860Moore WC, Meyers DA, Wenzel SE, Teague WG, Li H, Li X, D'Agostino R Jr, Castro M, Curran-Everett D, Fitzpatrick AM, Gaston B, Jarjour NN, Sorkness R, Calhoun WJ, Chung KF, Comhair SA, Dweik RA, Israel E, Peters SP, Busse WW, Erzurum SC, Bleecker ER; National Heart, Lung, and Blood Institute's Severe Asthma Research Program. Identification of asthma phenotypes using cluster analysis in the Severe Asthma Research Program. Am J Respir Crit Care Med. 2010 Feb 15;181(4):315-23. doi: 10.1164/rccm.200906-0896OC. Epub 2009 Nov 5.
- Background: PubMed 18480428Haldar P, Pavord ID, Shaw DE, Berry MA, Thomas M, Brightling CE, Wardlaw AJ, Green RH. Cluster analysis and clinical asthma phenotypes. Am J Respir Crit Care Med. 2008 Aug 1;178(3):218-224. doi: 10.1164/rccm.200711-1754OC. Epub 2008 May 14.
- Background: PubMed 19357143Weatherall M, Travers J, Shirtcliffe PM, Marsh SE, Williams MV, Nowitz MR, Aldington S, Beasley R. Distinct clinical phenotypes of airways disease defined by cluster analysis. Eur Respir J. 2009 Oct;34(4):812-8. doi: 10.1183/09031936.00174408. Epub 2009 Apr 8.
- Background: PubMed 21195471Fitzpatrick AM, Teague WG, Meyers DA, Peters SP, Li X, Li H, Wenzel SE, Aujla S, Castro M, Bacharier LB, Gaston BM, Bleecker ER, Moore WC; National Institutes of Health/National Heart, Lung, and Blood Institute Severe Asthma Research Program. Heterogeneity of severe asthma in childhood: confirmation by cluster analysis of children in the National Institutes of Health/National Heart, Lung, and Blood Institute Severe Asthma Research Program. J Allergy Clin Immunol. 2011 Feb;127(2):382-389.e1-13. doi: 10.1016/j.jaci.2010.11.015. Epub 2010 Dec 31.
- Background: PubMed 22267763Just J, Gouvis-Echraghi R, Rouve S, Wanin S, Moreau D, Annesi-Maesano I. Two novel, severe asthma phenotypes identified during childhood using a clustering approach. Eur Respir J. 2012 Jul;40(1):55-60. doi: 10.1183/09031936.00123411. Epub 2012 Jan 20.
- Background: PubMed 21281866Lotvall J, Akdis CA, Bacharier LB, Bjermer L, Casale TB, Custovic A, Lemanske RF Jr, Wardlaw AJ, Wenzel SE, Greenberger PA. Asthma endotypes: a new approach to classification of disease entities within the asthma syndrome. J Allergy Clin Immunol. 2011 Feb;127(2):355-60. doi: 10.1016/j.jaci.2010.11.037.
- Background: PubMed 22901886Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.
- Background: PubMed 21812663Corren J, Lemanske RF, Hanania NA, Korenblat PE, Parsey MV, Arron JR, Harris JM, Scheerens H, Wu LC, Su Z, Mosesova S, Eisner MD, Bohen SP, Matthews JG. Lebrikizumab treatment in adults with asthma. N Engl J Med. 2011 Sep 22;365(12):1088-98. doi: 10.1056/NEJMoa1106469. Epub 2011 Aug 3.
- Individual participant dataSharing planned: No
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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.
Ramesh J Kurukulaaratchy, DM FRCP principal investigator
University Hospital Southampton NHS Foundation Trust
3 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, run by University Hospital Southampton NHS Foundation Trust at 3 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 2 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: under way, not looking for participants, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
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?
Cohort Characterisation (time frame: 35 years). 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 NCT03996590, which also lists 14 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 19 Jan 2024.