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

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2008-008317-20-BE
• Date of registration: 21/09/2009
• Prospective Registration: Yes
• Primary sponsor: University Hospital Ghent
• Public title: The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function
• Scientific title: The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function
• Date of first enrolment: 13/11/2009
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008317-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cystic Fibrosis
MedDRA version: 12.0 Level: LLT Classification code 10011762 Term: Cystic fibrosis

Intervention(s)

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

Primary Outcome(s)

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

Main Objective: To establish the in vivo effect of N-acetylcysteine on sputum rheology and lung function compared to normal saline.

Secondary ID(s)

AGO/2008/014