Anti-Inflammatory Pulmonal Therapy of CF-Patients With Amitriptyline and Placebo
Cystic Fibrosis, Infection, Pseudomonas Aeruginosa
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, ceramide, amitriptyline, Pseudomonas aeruginosa, lung function
Eligibility Criteria
Inclusion Criteria:
- Cystic Fibrosis is proved
- The patient are older than 18 years (<50 years)
- No sec discrimination
- The patient is pulmonal colonized with bacteria
- Signs of pulmonary exacerbation are not present
- A full course of therapy is possible without any restrictions
- Lung function measurement is possible
Exclusion Criteria:
- Poor metabolizer for amitriptyline (CYP2D6 genotyping)
- Glaucoma, seizures, heart insufficiency or depression is present
- Signs of acute pulmonary illness (bronchial or tracheal stenosis, tuberculosis, thorax trauma, acute pneumonia, pneumothorax, bronchial haemorrhage, ARDS) are present
- intravenous antibiotic treatment was necessary in the last 4 weeks
- Involvement of the patient in another study
- Pregnancy
Sites / Locations
- University of Tuebingen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
1
2
3
0
Verum 1: Each individual capsule has a filling volume of 25 mg amitriptyline, given once an day in the evening over 28 days
Verum 1: Each individual capsule has a filling volume of 50 mg amitriptyline, given once an day in the evening over 28 days
Verum 3: Each individual capsule has a filling volume of 75 mg amitriptyline, given once an day in the evening over 28 days
Placebo: Each individual capsule has a filling volume of 25 mg placebo (corn starch), given once an day in the evening over 28 days