The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients
- Conditions
- MucoviscidoseMedDRA version: 9.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung
- Registration Number
- EUCTR2007-002707-40-BE
- Lead Sponsor
- niversity Hospital Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
All CF patients followed in the Ghent CF centre, 6 years or older and able to perform reproducible lung function measurements and to expectorate sputum guided by the physiotherapist.
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
CF patients with a drop of more than 5 % in FEV1 after inhalation of hypertonic saline. These patients will serve as a control group and will be asked to inhale for one month normal saline two times 4 ml per day.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the immediate effect of inhalation of 4 ml of hypertonic <br>saline (NaCl 7%) and the effect after one month of inhalation of 4 ml of <br>hypertonic saline, two times per day, on lung function and sputum rheology <br>(viscosity and elasticity) in CF patients <br>;Secondary Objective: ;Primary end point(s): - lung function<br>- sputum rheology (viscosity and elasticity)<br>
- Secondary Outcome Measures
Name Time Method