RecruitingPhase 2ACTRN12610000328077

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)


Sponsor

Vectura Limited (UK)

Enrollment

64 participants

Start Date

Jan 26, 2009

Study Type

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

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is testing whether inhaled heparin — a medication more commonly used to prevent blood clots — can help people with cystic fibrosis (CF) breathe more easily and have fewer infections. Cystic fibrosis causes thick, sticky mucus to build up in the lungs, leading to repeated infections and lung damage. Heparin inhaled as a mist may help thin the mucus and reduce inflammation in the airways. You may be eligible if: - You are 16 years or older - You are a non-smoker - You have a confirmed diagnosis of cystic fibrosis with lung disease - Your lung function (FEV1) is between 40% and 90% of normal for your age and height - You regularly produce mucus and can cough it up - You are using adequate contraception if you could become pregnant You may NOT be eligible if: - You have a known contraindication to heparin (e.g., history of heparin-induced low platelets, bleeding disorder) - You have significant liver disease or signs of portal hypertension - You are pregnant or breastfeeding - You have had or are planning major chest surgery during the trial - You have a current diagnosis of aspergilloma (a type of fungal lung infection) - You are taking regular blood-thinning medication like warfarin or aspirin Talk to your doctor about whether this trial might be right for you.

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 we

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)

United Kingdom

Ireland

Poland

Italy

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ACTRN12610000328077