Effect of OC459 on the Response to Rhinovirus Challenge in Asthma

NCT02660489 | Completed Phase 2 Results DMC

• 1 other identifier: ORCA2015
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Rhinovirus; Picornaviridae Infections; Common Cold

Keywords

CRTH2 antagonist; Prostaglandin D2 receptor; Anti-Asthmatic Agents; OC459; Allergic asthma; Eosinophilia

Outcome Measures

Primary Outcomes (1)

• Total Lower Respiratory Symptom Score

  Sum of daily scores for 14 days. Seven symptoms (cough on waking, wheeze on waking, daytime cough, daytime wheeze, daytime chest tightness, daytime breathlessness, nocturnal cough/wheeze/breathlessness) ranked from 0 (none) to 3 (severe). Range 0 to 294; higher is more symptomatic.

  During 14 days following rhinovirus inoculation

Secondary Outcomes (7)

• Change in Asthma Control Questionnaire (ACQ)-6 Score

  Baseline, 10 days post rhinovirus inoculation

• Percentage Change in Peak Expiratory Flow Rate

  Baseline and up to 14 days post rhinovirus inoculation

• Change in Forced Expiratory Volume in 1 Second (FEV1)

  Baseline and up to 14 days post rhinovirus inoculation

• Change in Exhaled Nitric Oxide (FeNO)

  Baseline and up to 10 days post rhinovirus inoculation

• Changes in Airway Hyper Responsiveness (Histamine)

  Baseline and 7 days post rhinovirus inoculation

Study Arms (2)

OC459 (CRTH2 antagonist)

EXPERIMENTAL

OC459 50mg once daily for 5 weeks

Drug: OC459; Other: Rhinovirus

Placebo

PLACEBO COMPARATOR

Placebo tablet once daily for 5 weeks

Drug: Placebo; Other: Rhinovirus

Interventions

OC459 DRUG

Also known as: OC000459

OC459 (CRTH2 antagonist)

Placebo DRUG

Placebo

Rhinovirus OTHER

Inoculation with rhinovirus serotype 16

OC459 (CRTH2 antagonist); Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Medical Research Council: collaborator
• Atopix Therapeutics, Ltd.: collaborator

Study Sites (1)

St Mary's Hospital

London, Greater London, W2 1PG, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Picornaviridae Infections; Common Cold; Eosinophilia

Interventions

(5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Professor Sebastian Johnston
• Organization: Imperial College London

s.johnston@imperial.ac.uk

+44 (0)20 7594 3764

Study Officials

• Sebastian L Johnston, MBBS PhD

  National Heart & Lung Institute, Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 21, 2016
• Study Start: January 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 26, 2021
• Results First Posted: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)