A trial to see whether the drug OC459 reduces the asthma symptoms induced by infection with the common cold

Phase 1

• Conditions: Asthma; MedDRA version: 20.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000015470; MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0 Level: LLT Classification code 10049868 Term: Asthma exacerbation prophylaxis System Organ Class: 100000022885; MedDRA version: 20.0 Level: LLT Classification code 10003638 Term: Atopic asthma System Organ Class: 100000015470; MedDRA version: 20.0 Level: LLT Classification code 10015575 Term: Exacerbation of asthma System Organ Class: 100000015470; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-002555-10-GB
• Lead Sponsor: Imperial College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-29
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 44

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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• Presence of clinically significant diseases other than asthma (cardiovascular, renal, hepatic, gastrointestinal, haematological, pulmonary, neurological, genitourinary, autoimmune, endocrine, metabolic, neoplasia etc.), 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 or during the 3 week run-in (prior to rhinovirus inoculation).
• Asthma exacerbation or viral illness within the previous 6 weeks or during the 3 week run-in (prior to rhinovirus inoculation).
• 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 (see note regarding contraception below).
• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified