Orally inhaled heparin in patients with cystic fibrosis (CF)

Phase 1

Recruiting

• Conditions: Pulmonary symptoms of cystic fibrosis; Human Genetics and Inherited Disorders - Cystic fibrosis

• Registration Number: ACTRN12610000328077
• Lead Sponsor: Vectura Limited (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Male or female, aged 16 years or older
2. Non-smoker
3. Written informed consent obtained prior to any trial specific procedures
4. Confirmed diagnosis of CF lung disease (i.e., respiratory clinical symptoms and positive sweat test or disease inducing mutations) by CF expert/investigator
5. Forced expiratory volume in one second (FEV1) at 40 - 90% of predicted value for age, sex and height at screening and baseline
6. FEV1 value at Baseline is within +/-15% of value at screening
7. Regular mucus production due to CF
8. Ease of sputum expectoration as defined by VAS score equal to or less than 80 mm
9. Inflammatory markers above upper limit of normal range.
10. Adequate contraceptive measures.
11. Able to comply with all protocol requirements 12. Able to use inhalation device.

Exclusion Criteria

To be eligible for inclusion into this trial, each patient must not violate any one of the following exclusion criteria at the time of screening, at the time of assessment or as specifically described below:
1. Any contraindication to Monoparin( Registered Trademark) considered clinically relevant
2. Increased bleeding risk
3. History of heparin-induced thrombocytopaenia
4. Patients with bleeding diathesis
5. Evidence of portal hypertension (e.g., hypersplenism or known grade III/IV oesophageal varices)
6. Clinically significant liver disease
7. Pregnancy at screening, or lactation
8. Previous thoracic or scheduled major surgery during trial
9. Any regular anticoagulant therapy (e.g., warfarin, aspirin) in the two weeks prior to screening
10. Modification of medication to treat respiratory disease between screening and baseline (Day 1)
11. Diagnosis or history of aspergilloma
12. Clinically significant serious disease or organ system disease not currently controlled / stable on present therapy
13. Planned hospitalisations which could interfere with trial compliance
14. Unable for any other reason to satisfactorily comply with the protocol (e.g., attendance for trial visits, treatment or assessments)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability assessed by treatment-emergent adverse events, laboratory data (including haematology, clinical chemistry and urinalysis); physical examination; vital signs including blood pressure, heart rate, respiratory rate, temperature and weight; concomitant medication.[Five visits to the trial centre are included: screening, baseline, week 2, week 4 and, for follow-up, week 6.]