Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis

Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic Fibrosis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01377792

Enrollment

Registered

2011-06-21

Start date

2009-03-31

Completion date

2012-09-30

Last updated

2013-01-30

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

Conditions

Cystic Fibrosis

Keywords

hypertonic saline, cystic fibrosis, pulmonary inflammation, pulmonary exacerbation

Brief summary

A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective, open and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. The purpose of this study is to verify if the long term inhalation (48 weeks) of major volume (10 ml) increases the free time without pulmonary exacerbation, and if this increase is superior to the obtained with the inhalation of the standard volume (5 ml) that has been advocated.

Interventions

DRUGHypertonic saline

comparison of different dosages of drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of Cystic fibrosis * Over 6 years old * FEV1 over than 30% * Must be able to perform a spirometry * Must be able to perform induced sputum * Must tolerate the maximum dose of 10 ml hypertonic saline * No oral neither intravenous treatment within the previous 2 weeks before the beginning of the study * No treatment with hypertonic saline in the 2 weeks before

Exclusion criteria

* No clinical diagnosis of Cystic Fibrosis * No tolerance of 10 ml of hypertonic saline * Positive pregnancy test * No tolerance of Beta2-agonist * Treatment with corticosteroids * FEV1 \< 30% * Liver and/or lung transplantation * Oxygen treatment * Hospital admission within the 4 previous weeks * Oral or intravenous antibiotic treatment within the 2 previous weeks * Smokers * Pulmonary colonisation with Burkholderia cepacia complex

Design outcomes

Primary

Measure	Time frame	Description
Free time, specified in days, of pulmonary exacerbation	12 months	Exact number of days, along 48 weeks of tretment with hypertonic saline, in wich the patient is free of pulmonary excaerbation symptoms and does not need antibiotics.

Secondary

Measure	Time frame	Description
Changes in lung function test measured by spirometry	12 months	—
Changes in inflammatory markers during the treatment	12 months	Measurement of inflammatory markers in induced sputum.
Quality of life	12 months	Measurement of quality of life of patients during treatment by CFQ-R test

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026