Status:
UNKNOWN
Asthma: Phenotyping Exacerbations 2
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
AstraZeneca
Conditions:
ASTHMA
Eligibility:
All Genders
18-85 years
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 coho...
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 ...
Eligibility Criteria
Inclusion
- INCLUSION
- 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 Participants who commence biologic therapy during the course of the study will be withdrawn.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.
Exclusion
Key Trial Info
Start Date :
November 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04293445
Start Date
November 22 2019
End Date
July 1 2022
Last Update
April 29 2021
Active Locations (1)
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1
Nottingham respriatory research unit
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB