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

Adelaida Lamas Ferreiro71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Hypertonic salineDRUG

comparison of different dosages of drug

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Cystic Fibrosis Unit. Ramón y Cajal University Hospital

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

Free time, specified in days, of pulmonary exacerbation

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.

Time frame: 12 months

Secondary Outcomes

Changes in lung function test measured by spirometry

Time frame: 12 months

Changes in inflammatory markers during the treatment

Measurement of inflammatory markers in induced sputum.

Time frame: 12 months

Quality of life

Measurement of quality of life of patients during treatment by CFQ-R test

Time frame: 12 months

Data from ClinicalTrials.gov

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