Effect of OC459 on the Response to Rhinovirus Challenge in Asthma
Condition: Asthma; Rhinovirus; Picornaviridae Infections; Common Cold
MeSH terms: Common Cold; Picornaviridae Infections; Asthma
Intervention: OC459; Placebo; Rhinovirus
Intervention description: Inoculation with rhinovirus serotype 16
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: CRTH2 antagonist; Prostaglandin D2 receptor; Anti-Asthmatic Agents; OC459; Allergic asthma; Eosinophilia

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.
    

Eligibility criteria:

        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 at
             home or at work

          -  Subjects who have known evidence of lack of adherence to medications and/or ability to
             follow physician's recommendations