EUCTR2019-000261-21-IE
Active, not recruiting
Phase 1
A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM)1
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis
- Sponsor
- Boehringer Ingelheim Limited
- Enrollment
- 98
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients / 12 years of age or older at screening;
- •2\. Documented diagnosis of cystic fibrosis including:
- •positive sweat chloride \= 60 mEq/L, by pilocarpine iontophoresis or
- •a genotype with 2 identifiable mutations consistent with cystic fibrosis accompanied by one or more clinical features with cystic fibrosis phenotype;
- •3\. FEV1 \= 40% and \= 90% of predicted values at screening and at predose at Visit 2 (randomisation).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 21
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 77
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •1\. Evidence of acute upper or lower respiratory tract infection within 4 weeks prior to randomisation based on investigator’s judgement;
- •2\. Pulmonary exacerbation requiring use of i.v./oral/inhaled antibiotics or oral corticosteroids within 4 weeks prior to randomisation;
Outcomes
Primary Outcomes
Not specified
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