A Study to Assess various doses of an ENaC inhibitor medication (mucociliary clearance) in Healthy Volunteers and People with Cystic Fibrosis
Details
- Therapeutic approach
- Mucociliary Clearance
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT002031
- Last updated
- 06/04/2020
A phase 1/2a study to assess various doses of an ENaC inhibitor medication called ION-827359 in Healthy Volunteers and People With Cystic Fibrosis
Study detailsA study medication called ION-827359 is being developed to treat lung disease symptoms in people with cystic fibrosis. The study medication is intended to help treat the thick mucus found in the airways of patients with cystic fibrosis.
This new inhaled (nebulized) medication will be investigated in both people with, and without cystic fibrosis. The study will compare the study medication with a placebo (a solution that looks identical to the study medication but contains no active ingredients), which means some participants will receive the study medication, whilst others will receive the placebo. Participants won’t know whether they are receiving the study medication or the placebo.
Participation in the study lasts for approximately 21 weeks (just over 5 months), and will require numerous visits to complete study assessments (blood tests, questionnaires, lung function etc.) to the recruitment centre.
- Phase
- Phase 2a
- CF sponsor
- Ionis Pharmaceuticals
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 18 years and older
- Including people
Confirmed diagnosis of CF
Weight >40Kg
FEV1 >/= 50% of predicted- Excluding people
Respiratory infection within 4 weeks of Study Day 1
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