Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis
- Conditions
- Cystic Fibrosis
- Interventions
- Drug: Hypertonic saline
- Registration Number
- NCT01377792
- Lead Sponsor
- Adelaida Lamas Ferreiro
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 ml Hypertonic saline - 10 ml Hypertonic saline -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Cystic Fibrosis Unit. Ramón y Cajal University Hospital
🇪🇸Madrid, Spain