Asthma with sensitization to aspergillus and isolation in sputum.
Conditions
Interventions
Trade Name: Vfend
Product Name: Voriconazole
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Tablet
Route of
Sponsors
University Hospitals of Leicester NHS trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Aged 18 and over Able to give consent Diagnosis of asthma and fungal sensitization or allergic bronchopulmonary aspergillosis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria Age under 18 Unable to give informed consent A principle diagnosis of COPD or bronchiectasis History of non compliance with medication, or unable to produce sputum. A co-morbid condition likely to increase the risk of side effects Pregnancy or possibility of becoming pregnant during the treatment phase of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In people with asthma who have evidence of a colonisation of their breathing tubes with a mould/fungus called Aspergillus fumigatus,will the treatment of this mould with the aim of the eradication from the breathing tubes reduce the frequency of severe asthma episodes (exacerbations) and improve the quality of life in patients with asthma.; Secondary Objective: Secondary outcome measures will be: •The percentage of patients whose sputum is no longer cultures AF after three months of treatment with Voriconazole and at the end of the study. •The change in the sputum eosinophil and total sputum neutrophil count in the Voriconazole versus the placebo group after three months of treatment and at the end of the study as meter of airway inflammation. •The change in FEV1 between the treatment and placebo group after treatment and at the end of the study, a measurement of breathing function. •The number of course of antibiotics between the treatment and placebo groups. •The improvement in symptoms and quality of life measurements at the end of the treatment and at the end of the study. ; Primary end point(s): There will be two primary outcome measures. Improvement in quality of life after three months of treatment and the number of severe exacerbations requring treatment with systemic glucocorticoids (SA) over the 12 months of the study. The study will be powered on severe exacerbations. | — |
Countries
United Kingdom
Outcome results
None listed