Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Study of the effectiveness of voriconazole in the treatment of Aspergillus fumigatus associated asthma: a randomised double blinded, placebo controlled trial
Acronym
EVITA3
Study hypothesis
Voriconazole will be effective in eradicating colonisation of the airways by Aspergillus fumigatus (AF) in patients with Aspergillus fumigatus associated asthma (AFAA) and this will result in a prolonged improvement in their disease control.
Ethics approval
Leicestershire, Northamptonshire & Rutland Research Ethics Committee 2, REC No. 09/H0402/63
Study design
Randomised double-blinded placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Asthma
Intervention
12 month randomised double-blind placebo-controlled parallel group trial to receive either placebo or voriconazole 200 mg twice daily orally for 12 weeks.
Intervention type
Drug
Phase
Not Applicable
Drug names
Voriconazole
Primary outcome measure
The number of severe exacerbations over the 12 months of the study.
Secondary outcome measures
1. The percentage of patients whose sputum is no longer AF positive after three months of treatment with voriconazole and at the end of the study
2. The change in the sputum eosinophil count (measured as area under the curve) in the voriconazole versus the placebo group after three months of treatment and at the end of the study
3. The change in the total sputum neutrophil count (measured as area under the curve) in the voriconazole versus the placebo group after three months of treatment and at the end of the study
4. The change in forced expiratory volume in one second (FEV1) between the treatment and placebo group after treatment and at the end of the study
5. The number of courses of antibiotics between the treatment and placebo groups
6. The improvement in Juniper Asthma Control Questionnaire (JACQ) score at the end of the treatment and at the end of the study
Overall trial start date
01/02/2009
Overall trial end date
08/07/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Symptoms consistent with a diagnosis of asthma
2. A clinical phenotype consistent with AF associated asthma in the opinion of at least two consultant members of the study team
3. Evidence of immune sensitisation to AF (either positive AF IgE, positive SPT to AF or positive AF IgG)
4. A raised peripheral blood eosinophil count or sputum eosinophil count of more than 10% on at least one occasion in the last two years
5. AF in sputum on two occasions within the six months prior to entry into the study
6. At least two severe exacerbations in the previous 12 months (defined as a requirement for a course of high dose oral steroids for treatment of their asthma)
7. Aged above 18 years, both male and female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Participant exclusion criteria
1. Unable to give informed consent
2. Pregnancy or possibility of becoming pregnant during the treatment phase of the study
3. A primary diagnosis (in the opinion of the study team) of chronic obstructive pulmonary disease (COPD) (smoking related obstructive disease)
4. Any conditions or drug interactions that in the opinion of the study team could lead to harmful interactions with voriconazole
5. Allergy to voriconazole
6. Poor compliance
7. Inability to produce sputum
Recruitment start date
01/02/2009
Recruitment end date
08/07/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Glenfield Hospital
Leicester
LE3 9QQ
United Kingdom
Sponsor information
Organisation
University Hospitals of Leicester NHS Trust (UK)
Sponsor details
c/o Professor Andrew Wardlaw
Glenfield Hospital
Groby Road
Leicester
LE3 9QQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
University/education
Funder name
University of Leicester (UK)
Alternative name(s)
UoL
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24290286