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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5 ml

Group Type ACTIVE_COMPARATOR

Hypertonic saline

Intervention Type DRUG

comparison of different dosages of drug

10 ml

Group Type ACTIVE_COMPARATOR

Hypertonic saline

Intervention Type DRUG

comparison of different dosages of drug

Interventions

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Hypertonic saline

comparison of different dosages of drug

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No