PULMATRIX 601-0018
Research type
Research Study
Full title
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Effect of Dose and Duration of Treatment of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) on Safety, Tolerability, and Potential Outcomes in Adult Patients with Asthma and Allergic Bronchopulmonary Aspergillosis
IRAS ID
1006803
Contact name
Margaret Wasilewski
Contact email
Sponsor organisation
PULMATRIX Inc.
Eudract number
2022-002289-33
Clinicaltrials.gov Identifier
Research summary
This study will investigate how safe, effective, and tolerable PUR1900 is compared to placebo in the treatment of ABPA (Allergic bronchopulmonary aspergillosis). ABPA is an allergic reaction to a fungus called Aspergillus fumigatus (Af), found naturally in the soil. In some people with asthma, the immune system overreacts to Af, resulting in damage to the airways, lungs and development of ABPA. To date, there are no approved therapies to treat ABPA. PUR1900 is an inhaled form of an oral antifungal medicine called itraconazole, used under the trade name Sporanox®. This study is sponsored by Pulmatrix Inc. PUR1900 is an investigational medication as it has not yet been approved by government agencies in any country to treat any condition. Its safety and how well it works when administered by inhalation are still being studied. About 30 participants aged 18 - 80 years, with asthma and ABPA, are expected to take part in this randomized, double-blind, multicenter, placebo-controlled study. The study will consist of a 28-day screening period, a 16-week treatment period, and an 8-week observation period. Following screening, patients will be randomly assigned into 1 of 3 treatment groups: PUR1900 20 mg (12 patients), PUR1900 40 mg (12 patients) and Matching Placebo (6 participants) with investigators, subjects, and the Sponsor not aware of treatment assignment. The study will monitor Treatment Emergent Adverse Events, frequency of exacerbations, Changes in sputum A. fumigatus antifungal susceptibility, among other end-points.
REC name
London - Fulham Research Ethics Committee
REC reference
22/LO/0840
Date of REC Opinion
16 May 2023
REC opinion
Further Information Favourable Opinion