Status:
UNKNOWN
Phenotyping Circulating and Lung Resident Eosinophils in Severe Asthma (P-CLESA)
Lead Sponsor:
Imperial College London
Conditions:
Severe Asthma
Eligibility:
All Genders
18-70 years
Brief Summary
Title: Phenotyping circulating and lung resident eosinophils in severe asthma (3 years). Background: Asthma is a long-term condition that affects the airways. When a person with asthma comes into con...
Detailed Description
Background: Severe asthma has been defined as "asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it fro...
Eligibility Criteria
Inclusion
- Male or female subject aged between 18 years and 70 years.
- Give written informed consent prior to participation in the study including all of its procedures.
- Comply with study protocol requirements
- Able to read, comprehend, and write at a sufficient level to complete study related materials.
- Able to complete the study and all measurements.
- All participants have been through a severe asthma protocol that have ascertained the diagnosis of severe asthma, maximised treatments and ensured adherence to therapy.
- Stable asthma therapy for at least a month before screening
- On \<10 mg maintenance OCS therapy
- Exclusion criteria:
- Subjects will not be eligible if any of the following apply: -
- As a result of medical interview, physical examination or screening investigation the investigators consider the subject unfit either because of risk to the subject due to the study or the influence this may have on the study results.
- A history of recreational drug use or allergy which in the opinion of the investigators contra-indicates their participation.
- Participation within 3 months in any a trial testing a new molecular entity or drug.
- Those, in the opinion of the investigator, who may prove non-compliant with study procedures.
- Within 4 weeks of screening visit been hospitalized or required high dose oral corticosteroid (\>30 mg prednisolone per day) therapy, asthma not been stable.
- Participants who have had prior treatment with bronchial thermoplasty, defined as completion of all thermoplasty treatment sessions within 6 months of screening
- History of significant pulmonary disease other than severe asthma.
- History of pulmonary eosinophilic syndrome or hyper eosinophilic syndrome.
- History of bronchopulmonary aspergillosis
Exclusion
- \-
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04463836
Start Date
September 1 2020
End Date
August 31 2023
Last Update
July 9 2020
Active Locations (1)
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1
Royal Brompton & Harefield NHS Trust,
London, United Kingdom, SW3 6HP