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

ISRCTN	ISRCTN42366088
DOI	https://doi.org/10.1186/ISRCTN42366088
Secondary identifying numbers	N/A

Submission date: 21/11/2008
Registration date: 30/01/2009
Last edited: 08/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andrew Wardlaw
Scientific

Glenfield Hospital
Groby Road
Leicester
LE3 9QQ
United Kingdom

Study information

Study design	Randomised double-blinded placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Study of the effectiveness of voriconazole in the treatment of Aspergillus fumigatus associated asthma: a randomised double blinded, placebo controlled trial
Study acronym	EVITA3
Study objectives	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(s)	Leicestershire, Northamptonshire & Rutland Research Ethics Committee 2, REC No. 09/H0402/63
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/02/2009
Completion date	08/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	70
Key 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
Key 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
Date of first enrolment	01/02/2009
Date of final enrolment	08/07/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Glenfield Hospital

Leicester
LE3 9QQ
United Kingdom

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

c/o Professor Andrew Wardlaw
Glenfield Hospital
Groby Road
Leicester
LE3 9QQ
England
United Kingdom

Website	http://www.le.ac.uk/external/
"ROR"	https://ror.org/02fha3693

Funders

Funder type

University/education

University of Leicester (UK)
Private sector organisation / Universities (academic only)

Alternative name(s): UoL
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2014		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

08/02/2016: Publication reference added.