Cystic Fibrosis MedDRA version: 12.0 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Conditions
Interventions
Trade Name: Lysomucil 10 %
Product Name: N-acetylcysteine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Acetylcysteine
CAS Number: 616-91-1
Concentration unit: ml millilitre(s)
Conc
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2. changes in visco-elasticity and lung function after one month of two doses per day of N-acetylcysteine compared to normal saline | — |
Countries
Belgium
Outcome results
None listed