Asthma: Phenotyping EXacerbations

NCT04293588 | Unknown

• 1 other identifier: 19051
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma exacerbations

Outcome Measures

Primary Outcomes (1)

• Proportion of study participants with an eosinophilic and non eosinophhilic phenotype

  Percentage of study participants with an eosinophilic and non eosinophhilic phenotype

  3 years into the study

Secondary Outcomes (9)

• The proportion of exacerbations associated with confrimed viral and bacterial infection

  3 years

• Asthma control questionnaire

  3 years

• Medication Adherence Rating Scale (MARS)

  3 years

• Measuring Lung function and inflamamtion

  3 years

• Blood profile

  3 years

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A population of asthmatics who have had an exacerbation in the 12 months prior to the study

You may qualify if:

• Clinician diagnosed asthma.
• Male or female aged ≥ 18 and ≤ 85 years of age.
• One asthma exacerbation requiring additional treatment in the year 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• AstraZeneca: collaborator

Study Sites (1)

Nottingham respriatory research unit

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Spirometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Tim rofessor Harrison, MBBS, BSc, FRCP, MD, MSc

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

0115 823 1714; tim.harrison@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: March 3, 2020
• Study Start: November 22, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

GB (1)