investigating the use of allopurinol as treatment for allergic asthma

Phase 1

• Conditions: Asthma; MedDRA version: 20.0Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-000164-42-GB
• Lead Sponsor: Tayside Medical Sciences Centre on behalf of University of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-09
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Male and female volunteers aged 18-65 years with stable mild to moderate asthma. Steroid naïve or receiving inhaled steroid up to 1000µg/day BDP equivalent dose, who are responsive to bronchial mannitol challenge – i.e. with a provocative mannitol dose to produce a 15 % fall in FEV1 (PD15) =635mg for bronchial challenge. Patients must be able to step down and stop inhaled corticosteroids (ICS), long acting ß-2 agonists (LABAs), leukotriene receptor antagonists (LTRAs), cromones, antihistamines, and remain be clinically stable throughout the study. This is defined as: FEV1 =60% predicted; Peak flow (PEF) =70% of reference value at screening; reliever use not >8puffs/day on two consecutive days
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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Other significant pulmonary disease (e.g. COPD) Smoking within 12 months of screening visit, uncontrolled symptoms of asthma; Pregnancy or lactation; known or suspected sensitivity to IMP; Inability to comply with protocol; Any clinically significant medical condition that may endanger the health or safety of the participant, or jeopardise the protocol; An asthma exacerbation requiring systemic steroids within 3 months of study commencement; Taking prohibited medication (as defined in protocol), Participation in another CTIMP within the past 30 days.

Study & Design

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