Condition category
Respiratory
Date applied
21/11/2008
Date assigned
30/01/2009
Last edited
08/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andrew Wardlaw

ORCID ID

Contact details

Glenfield Hospital
Groby Road
Leicester
LE3 9QQ
United Kingdom

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 measures

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

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

http://www.le.ac.uk/external/

Funders

Funder type

University/education

Funder name

University of Leicester (UK)

Alternative name(s)

UoL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24290286

Publication citations

Additional files

Editorial Notes

08/02/2016: Publication reference added.