Wessex Asthma Cohort of Difficult Asthma

NCT03996590 | Active Not Recruiting

• 1 other identifier: RHM MED1216
• Study Type: observational
• Target: 566
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Asthma

Keywords

Difficult Asthma; Severe Asthma

Outcome Measures

Primary Outcomes (1)

• 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

  35 years

Secondary Outcomes (2)

• Clinical Endotyping

  35 years

• Patient Stratification

  35 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe or difficult asthma referred to secondary and tertiary referral centres

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Novartis: collaborator
• Boehringer Ingelheim: collaborator
• National Institutes of Health (NIH): collaborator
• Owlstone Ltd: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (3)

Portsmouth Hospitals NHS Trust

Portsmouth, Hamsphire, PO6 3LY, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, Hamsphire, SO16 6YD, United Kingdom

Location

Isle of Wight NHS Trust

Newport, Isle Of Wight, PO30 5TG, United Kingdom

Location

Related Publications (14)

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• Mistry 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.

  PMID: 34534722 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ramesh J Kurukulaaratchy, DM FRCP

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 35 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 25, 2019
• Study Start: April 22, 2015
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)