A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - ND

• Conditions: Cystic Fibrosis; MedDRA version: 9.1Level: LLTClassification code 10011763

• Registration Number: EUCTR2007-006276-11-IT
• Lead Sponsor: VECTURA LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. Male or female ≥16 years; 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. Patient considered, in the Investigator s opinion, to be clinically stable and has at Screening and Baseline an FEV1 40 - 90% of predicted value for age, sex and height; 6. FEV1 value at Baseline is within +/-15% of FEV1 value 4 weeks earlier at Screening; 7. Regular mucus production due to CF; 8. Ease of sputum expectoration (i.e., clearability) VAS score of  80 mm; 9. Neutrophil elastase and / or IL-8 levels above detectable levels and/or upper limit of normal range for specified laboratory; 10. Adequate contraceptive measures (the subject [and his/her partner] should use adequate contraceptive measures, consisting of two forms of contraception, at least one of which must be a barrier method); 11. Able to comply with all the requirements of the protocol; 12. Able to use inhaler satisfactorily.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known sensitivity to any preparation of inhaled or parenteral heparin or the excipient leucine; 2. Any contra indication to Monoparin considered clinically relevant; 3. Increased bleeding risk 4. Clinically significant liver 5. Clinically significant serious disease or organ system disease not currently controlled / stable on present therapy; 6. Patients with a history of clinically or radiologically diagnosed aspergilloma; 7. Pregnancy at Screening; or lactation; 8. Planned hospitalisations which could interfere with trial compliance; 9. Previous thoracic or scheduled major surgery during trial period; 10. Previous or current regular use of proscribed medication defined as: a. Chronic / regular non-steroidal anti-inflammatory drug (NSAID) use (i.e., more than 3 times per week); b. Any regular anti coagulant therapy in the 2 weeks prior to Screening; c. Any previous use of inhaled heparin; d. Use of parenteral heparin 1 month prior to Screening; e. Use of other investigational drugs 1 month prior to Screening; f. Chronic / regular corticosteroid (1 month prior to Screening) g. Any regular inhaled tobramycin (Tobi) or other antibiotic use for oral, inhaled or parenteral treatment to be stable for at least 1 month prior to Screening and during the course of the trial h. Modification of medication to treat respiratory disease between Screening and Baseline (Day 1) i. Patients prescribed mucolytics, or hypertonic saline, but who have been taking them for less than 3 months prior to Screening are excluded. 11. 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 clinical trial of medicinal product
• Study Design: Not specified