Effect of OC459 on the Response to Rhinovirus Challenge in Asthma (NCT02660489) | Clinical Trial Compass
CompletedPhase 2
Effect of OC459 on the Response to Rhinovirus Challenge in Asthma
United Kingdom44 participantsStarted 2015-01
Plain-language summary
The aim of this study is to assess the effectiveness of a CRTH2 receptor antagonist, OC459, in preventing or attenuating the worsening of asthma symptoms during rhinovirus infection. The study is a double blind, randomised trial in which half the subjects will receive OC459 and the other half placebo, before being inoculated with rhinovirus, that would normally induce a worsening of asthma symptoms i.e. an exacerbation.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18--55 years
* Male or female
* Clinical diagnosis of asthma for at least 6 months prior to screening
* An Asthma Control Questionnaire (ACQ) Score \>0.75
* Positive histamine challenge test (PC20 \<8 µg/ml, or \<12 µg/ml and bronchodilator response ≥ 12%)
* Worsening asthma symptoms with infection since last change in asthma therapy
* Positive skin prick test to common aeroallergens (e.g. animal epithelia, dust mite)
* Treatment comprising inhaled corticosteroids (ICS) or combination inhaler (Long -Acting Beta Agonist with ICS), with a daily ICS dose of at least 100mcg fluticasone or equivalent.
* Participant is willing for their GP to be informed of their participation.
* English speaker
Exclusion Criteria:
* Presence of clinically significant diseases other than asthma, which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the study or the patient's ability to take part in it
* Smoking history over past 12 months
* Seasonal allergic rhinitis symptoms at screening
* Asthma exacerbation or viral illness within the previous 6 weeks
* Current or concomitant use of oral steroids, anti--leukotrienes or monoclonal antibodies
* Pregnant or breast-feeding women (patients should not be enrolled if they plan to become pregnant during the time of study participation)
* Contact with infants \<6 months or immunocompromised persons, elderly and infirm…
What they're measuring
1
Total Lower Respiratory Symptom Score
Timeframe: During 14 days following rhinovirus inoculation