Effects of inhaled hypertonic saline in children with cystic fibrosis

Effects of inhaled hypertonic (7%) saline on lung function test in preschool children with cystic fibrosis: a crossover, randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13412080

Enrollment

Registered

2016-07-06

Start date

2012-09-01

Completion date

Unknown

Last updated

2017-11-20

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

Conditions

Cystic fibrosis Genetic Diseases Cystic fibrosis

Interventions

Participants are randomly allocated to one of two groups who receive two treatments in a random order. Treatment 1: Participants receive inhalatory administration of 4ml hypertonic saline (HS - 7 % s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 4-6 years 2. Diagnosis of cystic fibrosis 3. Clinically stable 4. Undergoing a simple therapy based on bronchodilators and physiotherapy 5. No respiratory infections during the treatment or 2 weeks before

Exclusion criteria

Exclusion criteria: Children with instable medical conditions

Design outcomes

Primary

Measure	Time frame
1. Airways resistance was measured using interrupter resistance technique at baseline, 4, 16, 20, 32 weeks 2. FVC, FEV1 and FEF25-75 were measured using spirometry at baseline, 4, 16, 20, 32 weeks	—

Secondary

Measure	Time frame
Side effects were registered using a standardized questionnaire created for the purpose of this study throughout the 31 week study period by healthcare providers.	—

Countries

Italy

Outcome results

None listed

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