Asthma: Phenotyping Exacerbations 2

NCT ID: NCT04293445

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-22
• Study Completion Date: 2022-07-31

Brief Summary

The main outcomes of this study are to establish a cohort of well-phenotyped asthma patients with a recent history of an exacerbation. We aim to describe exacerbation profiles (phenotypes) of the cohort in terms of inflammatory/biomarker profile and bacterial/viral infection status and to compare these with exacerbation events in the sister APEX cohort.

Detailed Description

A single centre, observational, longitudinal cohort study. The study will consist of one group of approximately 100 patients with clinician diagnosed asthma, who have had at least one exacerbation in the past 5 years before informed consent. They will be identified from secondary care, primary care and the Nottingham Respiratory Research Database (NRRD).

After the Baseline visit, each subject will be followed for the duration of their participation in the study. Participants will be asked to contact the research team if they perceive that their asthma symptoms are worsening to the extent that they would usually seek help from a healthcare professional. They will then be invited to attend the Assessment Visit and potential Exacerbation Visit. Participants who complete this visit will then continue in the study, as we are interested in comparing subsequent events in the same individuals, to establish exacerbation stability and consistency.

All participants, whether they have attended an Assessment visit or not, will be invited to attend for an Annual visit. The research team will also contact participants at 3 monthly intervals, with their permission, to discuss the study and provide updates.

Conditions

ASTHMA

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

spirometry, FOT, Induced sputum, bloods, nasal brushes, nasal lavage, skin prick, throat swab

At the point of baseline visit, exacerbation and annual visit, the above tests will be performed to allow comparison of a participants profile before and during an exacerbation

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Clinician diagnosed asthma.
• Male or female aged ≥ 18 and ≤ 85 years of age.
• One asthma exacerbation requiring additional treatment in 5 years prior to informed consent. This is defined as either: 3 or more consecutive day's treatment with oral corticosteroids; for participants not on maintenance steroids, OR at least a doubling of treatment with oral corticosteroids for 3 or more consecutive days, from a stable dose, for participants on maintenance therapy with oral corticosteroids. These can be patient-reported.
• On British Thoracic Society (BTS) step 1-5 treatment
• Current smokers can be included, provided there is good evidence of underlying asthma (for example, a life-long history of asthma, > 12% FEV1 reversibility or sputum or blood eosinophilia).
• Able (in the Investigator's opinion) and willing to comply, with all clinical investigation requirements.
• Non-English speaking participants should be proficient in their understanding of the English language, in order to be able to fully participate in the study.

EXCLUSION:

• Exacerbation in the 4 weeks prior to the Baseline visit. The use of biologic therapy, including Omalizumab, Mepolizumab or Benralizumab, at any time during the 3 months.
• prior to informed consent. Participants who commence biologic therapy during the course of the study will be withdrawn.
• A history more in keeping with smoking-related Chronic Obstructive Pulmonary Disease (COPD)
• Other clinically significant respiratory diseases.
• Use of regular high dose maintenance systemic corticosteroids (for example, a dose of > 10mgs of Prednisolone daily)
• Any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the investigator, to impact on the ability to participate in the study or the study results.
• Pregnant women, lactating women or women who are planning to become pregnant.
• Participants with uncontrolled hypertension. Participation in a study involving an investigational medicinal product at any time during the 3 months prior to informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Professor Harrison, MBBS, BSc, FRCP, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Nottingham respriatory research unit

Nottingham, Nottinghamshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Tim Professor Harrison, MBBS, BSc, FRCP, MD, MSc

Role: CONTACT

tim.harrison@nottingham.ac.uk

0115 823 1714

Facility Contacts

Tim Professor Harrison, MBBS, BSc, FRCP, MD, MSc

Role: primary

tim.harrison@nottingham.ac.uk

0115 823 1714

Ashish Pradhan, MBBS

Role: backup

ashish.pradhan@nottingham.ac.uk

0115 823 1695

Other Identifiers

19055

Identifier Type: -

Identifier Source: org_study_id