Anti-Inflammatory Pulmonal Therapy of CF-Patients With Amitriptyline and Placebo

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00515229
• Date of registration: 09/08/2007
• Prospective Registration: No
• Primary sponsor: University Hospital Tuebingen
• Public title: Anti-Inflammatory Pulmonal Therapy of CF-Patients With Amitriptyline and Placebo
• Scientific title: Protocol for a Phase II-Study Anti-Inflammatory Pulmonal Therapy of CF-Patients With Amitriptyline and Placebo - Randomised, Double-Blinded, Placebo-Controlled, Cross Over - Study -
• Date of first enrolment: October 2006
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00515229
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Joachim Reithmueller, Dr.
• Affiliation: University of Tuebingen, Paediatric Department

Key inclusion & exclusion criteria

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

Exclusion Criteria:

1. Poor metabolizer for amitriptyline (CYP2D6 genotyping)

2. Glaucoma, seizures, heart insufficiency or depression is present

3. Signs of acute pulmonary illness (bronchial or tracheal stenosis, tuberculosis,
thorax trauma, 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pseudomonas Aeruginosa

Infection

Cystic Fibrosis

Intervention(s)

Drug: amitriptyline

Primary Outcome(s)

Increase in lung function, especially the FEV1 increase [Time Frame: 5 months]

Secondary Outcome(s)

Decrease of leukocytes (sputum) [Time Frame: 5 months]

Pulmonary Ceramide expression [Time Frame: 5 months]

Decrease of cytokine-concentrations [Time Frame: 5 months]

Decrease of Pseudomonas [Time Frame: 5 months]

Exacerbations [Time Frame: 5 months]

Increase of CO-Diffusion [Time Frame: 5 months]

Infection parameters in serum [Time Frame: 5 months]

Secondary ID(s)

APA-II

Source(s) of Monetary Support

Please refer to primary and secondary sponsors