Orally inhaled heparin in patients with cystic fibrosis (CF)
A phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin inhalation in patients with cystic fibrosis (CF)
Vectura Limited (UK)
64 participants
Jan 26, 2009
Interventional
Conditions
Summary
The clinical trial is to assess the safety and tolerability and to explore the efficacy of orally inhaled heparin in patients with cystic fibrosis (CF). Heparin is expected to provide advantages over currently available treatments for CF in a convenient delivery system.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Patients will be randomised to receive one of three daily dose levels of heparin treatment or matching placebo; to be self-administered by inhalation by the patient twice daily for four consecutive weeks. Nominal Daily Doses to be studied are: 11400 International Units (IU), 22800 IU and 45600 IU. For each patient there will be a screening period of 4 weeks, a treatment period of 4 weeks with a follow-up period of 2 weeks.
Locations(4)
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ACTRN12610000328077