CWoW - Phase 2 study to evaluate PUR1900 in asthmatic patients with ABPA
Research type
Research Study
Full title
A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis
IRAS ID
257243
Contact name
David Denning
Contact email
Sponsor organisation
Pulmatrix, Inc.
Eudract number
2018-002949-11
Duration of Study in the UK
0 years, 9 months, 28 days
Research summary
This is a clinical research study of a potential new treatment called PUR1900 (itraconazole) in asthmatic participants with Allergic Bronchopulmonary Aspergillosis (ABPA).
ABPA is a form of lung disease that occurs in some people who are allergic to Aspergillus, a type of fungus (mould) commonly found in soil, dust, water and rotting, or decaying vegetation. This allergic reaction causes the immune system to overact to Aspergillus, which can lead to lung inflammation, mucus build-up and worsening of asthma symptoms. ABPA can lead to bronchiectasis, a form of airway damage that can result in worsening lung function and increased risk of infection. Standard treatment is oral corticosteroids and antifungal medications, in addition to the usual asthma medication.
PUR1900 is an inhaled form of the antifungal medication itraconazole. The purpose of this study is to determine if PUR1900 is safe and well tolerated, and to determine whether treatment with PUR1900 may affect markers of inflammation associated with ABPA when given for 4 weeks to participants with asthma and ABPA.
This study will include a total of 64 participants, with approximately 8 participants from 4 sites in the UK. Study participation will last up to 9 weeks, and will include 8 visits to site. This includes a 28-day screening period (2 visits), a further 5 visits across the 4-week treatment period, and a follow up visit.
Study participants will be placed into one of four treatment groups in a 1:1:1:1 ratio:
• 10mg of PUR1900
• 20mg of PUR1900
• 35mg of PUR1900
• Placebo
Study drug will be administered orally, using an inhaler, once daily for 28 days. Participants will have a 3 in 4 chance of receiving PUR1900.The study involves procedures including: physical examination, vital signs, blood tests, sputum samples, spirometry (a measure of lung function), electrocardiogram (ECG), chest X-ray and questionnaires.
This study is sponsored by Pulmatrix, Inc.
REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0161
Date of REC Opinion
15 Apr 2019
REC opinion
Further Information Favourable Opinion