Assessment of Citramel in Patients with Cystic Fibrosis
Phase 2
Completed
- Conditions
- Cystic FibrosisRespiratory - Other respiratory disorders / diseasesHuman Genetics and Inherited Disorders - Cystic fibrosis
- Registration Number
- ACTRN12615000654550
- Lead Sponsor
- Breathe Easy Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Confirmed diagnosis of cystic fibrosis; aged at least 16 years who provide written informed consent; sexually active females must use contraception; stable medications; FEV1 between 40-100% of normal range.
Exclusion Criteria
Clinically significant co-existing disease; current or previous clinically significant smoking history; ECG or blood pressure abnormalities; use of a bronchodilator within 12hrs prior to bronchodilator challenge at screening; renal impairment; elevated liver enzymes;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety as measured by adverse events, Laboratory tests, vital signs and patient diary [Screening/baseline, Day 3 or 4, weeks 1, 2, 3 and 4 of each of the two treatment periods. Adverse events also assessed at two weeks post last dose of Week 4 of each of the two treatment periods. ]
- Secondary Outcome Measures
Name Time Method