Azole Therapy in Cystic Fibrosis (ATCF)
Research type
Research Study
Full title
Azole Therapy in Cystic Fibrosis (ATCF) : Efficacy of itraconazole and of voriconazole in patients with cystic fibrosis and presenting with persistent positive sputums for Aspergillus
IRAS ID
101049
Contact name
Alex Horsley
Sponsor organisation
CHU de Rennes (Rennes University Hospital Centre)
Eudract number
2011-005799-41
Clinicaltrials.gov Identifier
Research summary
Cystic Fibrosis (CF) is characterised by chronic infection in the lungs and progressive decline in lung function. The fungus Aspergillus fumigatus is increasingly recognised as an important organism responsible for lung infection in CF. Aspergillus is a widespread environmental fungus to which all of us are exposed. It is especially problematic in CF however where it causes a spectrum of disease including chronic airway infection (approximately 50% adults), severe pneumonia, and allergic reactions that cause wheeze and airway blockage. Infection with Aspergillus is associated with poorer outcomes and faster decline in lung function in CF. Although it is now increasingly appreciated that these infections are potentially harmful, little is known about the best method of managing or eradicating these infections. Treatment typically involves courses of the antifungal medications itraconazole or voriconazole. Although itraconazole is used most commonly in clinical practice, voriconazole may prove to be a more effective treatment. In both cases, little is understood about the best doses to use, how these are absorbed in CF, the length of therapy required, and success and side effect rates. These are both expensive therapies with a broad range of possible side-effects. In order to offer more effective treatment of Aspergillus infections, it is important to assess these therapies in a prospective trial. In this trial, CF patients with Aspergillus infection will be randomised to treatment with either itraconazole or voriconazole for up to 6 months, with close monitoring of drug levels and assessment of effects on Aspergillus infection. Defining the dosing and length of treatment will reduce costs and side effects and allow clinicians to better inform patients about the outcomes of therapy.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
12/NW/0639
Date of REC Opinion
4 Oct 2012
REC opinion
Further Information Favourable Opinion