Anti-inflammatory Pulmonal Therapy of Cystic Fibrosis (CF) Patients With Amitriptyline and Placebo

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01309178
• Date of registration: 04/03/2011
• Prospective Registration: No
• Primary sponsor: University Children’s Hospital Tuebingen
• Public title: Anti-inflammatory Pulmonal Therapy of Cystic Fibrosis (CF) Patients With Amitriptyline and Placebo APA-IIb
• Scientific title: Anti-inflammatory Pulmonal Therapy of CF Patients With Amitriptyline and Placebo - a Randomised, Double-blind, Placebo-controlled, Multicenter, Cohort - Study
• Date of first enrolment: May 2009
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01309178
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Joachim Riethmueller, Dr.

• Name: Joachim Riethmueller, Dr
• Affiliation: University Children´s Hospital Tubeingen, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Cystic Fibrosis is verified

- Patient is older than 14 years

- Patients weight is more than 35 kg

- FEV1 is higher than 30% and lower than 90%

- The patient is pulmonal colonized with bacteria

- No acute pulmonal illness is present

- CRP is not elevated two fold (2 mg/dl) of normal

- Lung function testing is possible

- A full course of therapy is possible without any restrictions

Exclusion Criteria:

- FEV1 in baseline differs more than 10% from screening visit

- CRP in baseline differs more than 50% from screening visit

- Glaucoma, seizures, heart insufficiency or major depression are present

- Intravenous antibiotic treatment was necessary in the last 4 weeks before visit 2

- High dose steroid therapy

- On-off-therapy of tobramycin in the last 2 weeks

- Involvement of the patient in another study

- Pregnancy and

- Nursing mothers



Age minimum: 14 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Pneumonia

Intervention(s)

Drug: Mannite

Drug: Amitriptyline

Primary Outcome(s)

Improvement of the lung function parameter FEV1 (absolute and relative to baseline) under verum and placebo [Time Frame: in 4 weeks]

Secondary Outcome(s)

Bacteriological and cell status [Time Frame: in 4 weeks]

Ceramide concentration in epithelial cells [Time Frame: in 4 weeks]

Inflammation status [Time Frame: in 4 weeks]

Increase in lung function measurements [Time Frame: in 2 and 4 weeks]

Side effects [Time Frame: in 4 weeks]

Secondary ID(s)

APA-IIb

2008-002673-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Ulm

Universität Duisburg-Essen