A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler – BALANCE – CF(TM)1

Phase 1

• Conditions: Cystic Fibrosis; MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-000261-21-BE
• Lead Sponsor: SCS Boehringer Ingelheim Comm.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-29
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 98

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
F.1.3.1 Number of subjects for this age range

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified