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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 7 October 2014
Main ID:  EUCTR2007-002707-40-BE
Date of registration: 04/06/2007
Prospective Registration: Yes
Primary sponsor: University Hospital Ghent
Public title: The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients
Scientific title: The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients
Date of first enrolment: 28/06/2007
Target sample size: 60
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002707-40
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Belgium
Contacts
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Key inclusion & exclusion criteria
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Mucoviscidose
MedDRA version: 9.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
Intervention(s)

Product Name: Hypertonic saline solution
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sodium Chloride
CAS Number: 7647-14-5
Concentration unit: % percent
Concentration type: equal
Concentration number: 7-

Product Name: Normal saline solution
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sodium Chloride
CAS Number: 7647-14-5
Concentration unit: % percent
Concentration type: equal
Concentration number: 0,9-

Primary Outcome(s)
Main Objective: To study the immediate effect of inhalation of 4 ml of hypertonic
saline (NaCl 7%) and the effect after one month of inhalation of 4 ml of
hypertonic saline, two times per day, on lung function and sputum rheology
(viscosity and elasticity) in CF patients
Primary end point(s): - lung function
- sputum rheology (viscosity and elasticity)
Secondary Objective:
Secondary Outcome(s)
Secondary ID(s)
AGO/2007/004
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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