The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002707-40-BE

Enrollment

Registered

2007-06-04

Start date

2007-06-28

Completion date

Unknown

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucoviscidose MedDRA version: 9.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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 ;Secondary Objective: ;Primary end point(s): - lung function - sputum rheology (viscosity and elasticity)	—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026