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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Lower Respiratory Symptom Score
Timeframe: During 14 days following rhinovirus inoculation