Asthma MedDRA version: 20.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Allopurinol
Product Name: Allopurinol
Pharmaceutical Form: Capsule
INN or Proposed INN: Allopurinol
CAS Number: 315-30-0
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
Tayside Medical Sciences Centre on behalf of University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does allopurinol confer any anti-inflammatory benefit to the airways of patients with asthma? In specific, does it reduce airway hyperresponsiveness (a marker of disease activity). This will be measured by challenging the airways with a drug designed to provoke bronchoconstriction. We hypothesise that patients on allopurinol will be less reactive to the bronchial challenge. Thereby demonstrating it has tangible anti-inflammatory properties to the airways of asthmatic patients. ;Secondary Objective: Does allopurinol improve conventional measures of pulmonary function based on the breathing tests of spirometry (a forced breathing test), impulse oscillometry (a passive breathing test), Exhaled nitric oxide (passive), blood tests that measure inflammation in asthma (eosinophils, eosinophilic cationic protein), and asthma questionnaires (asthma control questionnaire, asthma quality of life questionnaire). ;Primary end point(s): Mannitol PD15 (Provocation dose of mannitol causing 15% drop in FEV1);Timepoint(s) of evaluation of this end point: 14 days (but allowed + 3 days over this for flexibility of visits) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Spirometry IOS FeNO Salbutamol recovery post-mannitol challenge Blood eosinophils and serum ECP IgE (immunoglobulin E) AQLQ (Asthma Quality of Life Questionnaire) ACQ (Asthma Control Questionnaire) Asthma VAS (Asthma Visual Analogue Scale);Timepoint(s) of evaluation of this end point: 14 days (but allowed + 3 days over this for flexibility of visits) | — |
Countries
United Kingdom
Contacts
Public ContactLipworth
University of Dundee
Outcome results
None listed