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

Study Overview
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: Hypertonic saline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 ml<br> | Drug: Hypertonic saline<br>* comparison of different dosages of drug<br>|
| Active Comparator: 10 ml<br> | Drug: Hypertonic saline<br>* comparison of different dosages of drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertonic saline, cystic fibrosis, pulmonary inflammation, pulmonary exacerbation