The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung functio

• Conditions: Cystic Fibrosis; MedDRA version: 12.0Level: LLTClassification code 10011762Term: Cystic fibrosis

• Registration Number: EUCTR2008-008317-20-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-21
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Patients who can perform lung function tests and who can produce sputum (> 5 years of age)
- (Fe)males between 6-64 years
- Patiënts has signed informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients on the waiting lists for lung transplant.
- Pregnancy or breast feeding
- Patients can not take part in another ‘inhalation’trial for Cystic Fibrosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the in vivo effect of N-acetylcysteine on sputum rheology and lung function compared to normal saline.;Secondary Objective: ;Primary end point(s): 1. changes in visco-elasticity and lung function after one dose of N-acetylcystein compared to normal saline <br>2. changes in visco-elasticity and lung function after one month of two doses per day of N-acetylcysteine compared to normal saline<br>