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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 ml | Active Comparator |
| |
| 10 ml | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline | Drug | comparison of different dosages of drug |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adelaida Lamas, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cystic Fibrosis Unit. Ramón y Cajal University Hospital | Madrid | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Quality of life | Measurement of quality of life of patients during treatment by CFQ-R test | 12 months |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |