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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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.
Address: 
Telephone:
Email:
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
Cystic Fibrosis
Infection
Pseudomonas Aeruginosa
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]
Infection parameters in serum [Time Frame: 5 months]
Increase of CO-Diffusion [Time Frame: 5 months]
Decrease of cytokine-concentrations [Time Frame: 5 months]
Decrease of Pseudomonas [Time Frame: 5 months]
Exacerbations [Time Frame: 5 months]
Secondary ID(s)
APA-II
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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