Study of the effectiveness of voriconazole in the treatment of Aspergillus fumigatus associated asthma

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN42366088
• Date of registration: 30/01/2009
• Primary sponsor: University Hospitals of Leicester NHS Trust (UK)
• Public title: Study of the effectiveness of voriconazole in the treatment of Aspergillus fumigatus associated asthma EVITA3
• Scientific title: Study of the effectiveness of voriconazole in the treatment of Aspergillus fumigatus associated asthma: a randomised double blinded, placebo controlled trial
• Date of first enrolment: Feb 1 2009
• Target sample size: 70
• Recruitment status: Ongoing/Recruiting
• URL: http://isrctn.org/ISRCTN42366088
• Study type: Interventional
• Study design: Randomised double-blinded placebo-controlled trial

Countries of recruitment

United Kingdom

Contacts

• Name: Andrew Wardlaw

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

12 month randomised double-blind placebo-controlled parallel group trial to receive either placebo or voriconazole 200 mg twice daily orally for 12 weeks.

Primary Outcome(s)

The number of severe exacerbations over the 12 months of the study.

Secondary Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

University of Leicester (UK)

Secondary Sponsor(s)

N/A