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Be Part of Research - Trial Details - Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and ABPA
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Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and ABPA

Stopped

Open to: ALL

Age: 18.0 - N/A

London Birmingham Glasgow Manchester

Medical Conditions

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The goal of this clinical trial is to learn about PUR1900 as an inhaled, antifungal therapeutic for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The main questions it aims to answer are:

1. Is PUR1900 safe and well tolerated in adults with asthma and ABPA? 2. Is there an effect of daily administration of PUR1900 on potential outcome measures in adults with asthma and ABPA? 3. Is there fungal resistance to A. fumigatus?

This study includes a 28-day screening period, a 112-day (16-week) treatment period, and a 56-day (8 week) observation period.

Participants will take either 40mg of PUR1900, 20 mg of PUR1900 or Placebo for 112 days and complete an eDairy, answer questions about their asthma and complete peak respiratory flow measurements at home. They will come to the clinic approximate once a month during the treatment period and complete study assessments. At the end of the observation period participants will complete one more clinic visit. Participants who complete this study may be given the opportunity to continue on study drug in an open label extension study.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2023 Feb 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Capsules with 20 mg total powder (10 mg itraconazole plus 10 mg excipients)

Intervention Arm Group : PUR1900 20 mg;PUR1900 40 mg;

Intervention Type : DRUG
Intervention Description : Capsules with 11.8 mg total powder (excipients only)

Intervention Arm Group : Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Brompton Hospital
    London
    SW3 6HP
  • University Hospitals Birmingham - Heartlands Hospital
    Birmingham
    West Midlands
    B9 5SS
  • CPS Research Limited
    Glasgow
    G20 7BE
  • University Hospital of South Manchester - Wythenshawe Hospital,
    Manchester
    M23 9LT


The study is sponsored by Pulmatrix Inc.




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Read full details for Trial ID: NCT05667662
Last updated 01 April 2024

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