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

INTERVENTION: 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) Concentration type: equal Concentration number: 3‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Inhalation use CONDITION: Cystic Fibrosis ; MedDRA version: 12.0 Level: LLT Classification code 10011762 Term: Cystic fibrosis PRIMARY OUTCOME: Main Objective: To establish the in vivo effect of N‐acetylcysteine on sputum rheology and lung function compared to normal saline. 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; Secondary Objective: 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