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.
Conditions
Interventions
Trade Name: Amitriptylin-ct Tabletten
Wirkstoffstärke 75 mg
Product Name: Amitriptyline
Pharmaceutical Form: Capsule*
INN or Proposed INN: AMITRIPTYLINE
CAS Number: 50486
Current Sponsor code: Amitri
Sponsors
Paediatrisches Sekretariat fuer Klinische Studien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Cystic Fibrosis is proved 2. The patient are older than 18 years (=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. Increase of CO-Diffusion 2. pulmonary Ceramid expression 3. Decrease of cytokine-concentrations, LBP and decrease of IL-10 in sputa and serum 4. Decrease of leukocytes (degranulation) in sputum, 5. Decrease of Pseudomonas colonization 6. cDNA-Micro-Chip-Analysis of infection parameters in serum 7. Exacerbations;Primary end point(s): Lung function: FEV1;Main Objective: Increase in lung function, especially the FEV1 increase | — |
Countries
Germany
Outcome results
None listed