The Effect of Anti-IL17 on Airway Hyperresponsiveness and Resistance
ConditionAsthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCopenhagen University Hospital, Hvidovre
About this trial
This observational longitudinal cohort study aims to assess the effect of monoclonal antibodies targeting interleukin 17 (anti-IL-17) on airway hyperreactivity and airway resistance. The study involves adult participants suffering from dermatological or rheumatological illness, who are planning to start treatment with monoclonal antibodies targeting interleukin 17 as a part of the treatment of these diseases.
The primary outcome of this study will be changes in airway hyperresponsiveness to methacholine challenge reported as response-dose-ratio before and after initiation of anti-IL17 treatment regardless of presence of respiratory disease. Furthermore, the potential effect of anti-IL-17 on airway resistance will be assessed using conventional spirometry for measuring changes in FEV1 and Airwave oscillometry.
A reduced degree of airway hyperreactivity and airway resistance after initiating ani-IL-17 could indicate effectiveness of anti-IL-17 in asthma patients which would have to be examined further in a population of asthma patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients planning to start treatment with anti-IL-17 antibodies
Disqualifiers
Current pregnancy
FEV1 < 1.5L or less than 60% of predicted value expected.
Previous anaphylactic shock or severe allergic reaction to medicine
Uncontrolled hypertension
Trial population
Participants will be adult (18 years or older) rheumatologic og dermatologic patients planning to start treatment with anti-IL-17 antibodies. Participants must not have any conditions excluding them from performing a methacholine challenge (Previous anaphylactic shock, current pregnancy, recent cardiac disease, or FEV1 below 1,5L or 60% of expected. Furthermore, patients must not have been treated with systemic corticosteroids within the past 6 weeks.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Airway hyperresponsiveness
Airway responsiveness to methacholine challenge before and after initiation of anti-IL-17 treatment reported as a dose-response-ratio
Time frame
approximately 4 monthsSecondary outcomes
1
Airway resistance
Airway resistance will be assessed using both conventional spirometry for measuring changes in FEV1 and Airwave oscillometry
Time frame
approximately 4 monthsSponsors and contacts
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Source ClinicalTrials.gov