NCT02660489

Effect of OC459 on the Response to Rhinovirus Challenge in Asthma

Effect of the CRTH2 Antagonist OC459 on the Response to Rhinovirus Challenge in Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Asthma is the most common chronic respiratory disease, and in many countries prevalence is rising. The major morbidity, mortality and health care costs related to asthma are a result of periods of acutely increased symptomatology called 'exacerbations'. Most exacerbations are caused by rhinovirus, the virus associated with the common cold. There are few treatments to prevent and treat exacerbations, and despite these \>50% of adult asthmatics reported having an exacerbation in the last year. There is therefore a major unmet need. Experimentally inoculating patients with asthma with rhinovirus, a methodology that has been safely used for \>15 years, induces an infection and worsening symptoms in \~85%. This model offers the possibility to investigate treatment effects on asthma exacerbations with a small number of subjects, minimising the numbers exposed to a novel drug with limited safety data. In contrast, trials of therapies powered to evaluate an effect on naturally occurring exacerbations require several hundred subjects, a long study period to capture enough events, and are significantly more expensive to carry out. Using this model the investigators have shown that several inflammatory molecules, including prostaglandin D2 (PGD2), are significantly increased during rhinovirus-induced asthma exacerbations, with the levels of PGD2 strongly correlating with the severity of the symptoms. Moreover other studies have shown that when PGD2 binds the CRTH2 receptor, it stimulates the release of a number of inflammatory molecules also associated with asthma exacerbations. Blocking the CRTH2 receptor therefore appears an extremely promising target with potential to limit the virus-induced inflammation underpinning many asthma exacerbations.

Conditions

• Asthma
• Rhinovirus
• Picornaviridae Infections
• Common Cold

Interventions

Type	Name	Description
DRUG	OC459
DRUG	Placebo
OTHER	Rhinovirus	Inoculation with rhinovirus serotype 16

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-01-21
• Last updated: 2021-02-26
• Results posted: 2021-02-26

Locations

1 site across 1 country: United Kingdom