Therapy of lungs of CF-patients with Amitriptyline - a randomised, double-blind, placebo-controlled cohort trial

Phase 1

• Conditions: Amitriptyline reduces ceramide concentrations in bronchial epithelial cells and reduces cell death and reduces the deposition of DNA on the respiratory epithelium. This reduction promotes the elimination of P. aeruginosa bacteria from the lung. As a result, treatment normalizes inflammation in CF lungs. Amitriptyline thus reduces systemic and local inflammation. Because of these effects, amitriptyline increases lung function in CF patients.; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-003581-25-DE
• Lead Sponsor: niversity Hospital Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-15
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1.Cystic Fibrosis is verified;
2.Patient is older than 12 years;
3.Patients weight is more than 35 kg;
4.FEV1 is higher than 25% and lower than 100% (two times in 3 months);
5.The patients lung is colonised with bacteria;
6.No acute pulmonal illness is present;
7.Lung function testing is possible;
8.A full course of therapy is possible without any restrictions;
9.Informed consent is given.

Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 87
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.FEV1 in screening and baseline differs more than 10%;
2.Clinicial detoriation is present (exacerbation symptoms);
3.Change of CRP of more than 50% in screening period;
4.Glaucoma, seizures, heart insufficiency or major depression is pre-sent;
5.Intravenous antibiotic treatment was necessary for the last 2 weeks prior to the trial;
6.High dose steroid therapy;
7.On-therapy of tobramycine in the last 2 weeks;
8.Involvement of the patient in another study;
9.Pregnancy.

Study & Design

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