Protocol for a Phase II-studyAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - a randomised, double-blinded, placebo-controlled, cross over study

Phase 1

• Conditions: CF-patients develop a chronic pulmonary infection with Pseudomonas aeruginosa (P. aeruginosa). At present it is unknown why CF-patients are highly sensitive to P. aeruginosa infections and, most important, no curative treatment for cystic fibrosis is available. This Study should provide a novel anti-inflammatory treatment for cystic fibrosis, which reduces pulmonary complications, progression of the disease and may possibly increase the life-expectance of the patients.

• Registration Number: EUCTR2006-002259-33-DE
• Lead Sponsor: Paediatrisches Sekretariat fuer Klinische Studien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-11
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1.Cystic Fibrosis is proved
2.The patient are older than 18 years (<50 years)
3.No sec discrimination
4.The patient is pulmonal colonized with bacteria
5.Signs of pulmonary exacerbation are not present
6.A full course of therapy is possible without any restrictions
7.Lung function measurement is possible
Are the trial subjects under 18? no
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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Non responder for amitriptyline (CYP2D6 genotype)
2.Glaucoma, seizures, heart insufficiency or depression is present
3.Signs of acute pulmonary illness (bronchial or tracheal stenosis, tu-berculosis, thoraxtrauma, acute pneumonia, pneumothorax, bronchial haemorrhage, ARDS) are present
4.intravenous antibiotic treatment was necessary in the last 4 weeks
5.Involvement of the patient in another study
6.Pregnancy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: 1.Increase of CO-Diffusion<br>2.pulmonary Ceramid expression<br>3.Decrease of cytokine-concentrations,<br> LBP and decrease of IL-10 in sputa and serum<br>4.Decrease of leukocytes (degranulation) in sputum,<br>5.Decrease of Pseudomonas colonization<br>6.cDNA-Micro-Chip-Analysis of infection parameters in serum<br>7.Exacerbations;Primary end point(s): Lung function: FEV1;Main Objective: Increase in lung function, especially the FEV1 increase