Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-29 @ 6:20 AM
Study NCT ID:
NCT01377792
Status:
COMPLETED
Last Update Posted:
2013-01-30
First Post:
2011-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-29', 'studyFirstSubmitDate': '2011-05-09', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Free time, specified in days, of pulmonary exacerbation', 'timeFrame': '12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in lung function test measured by spirometry', 'timeFrame': '12 months'}, {'measure': 'Changes in inflammatory markers during the treatment', 'timeFrame': '12 months', 'description': 'Measurement of inflammatory markers in induced sputum.'}, {'measure': 'Quality of life', 'timeFrame': '12 months', 'description': 'Measurement of quality of life of patients during treatment by CFQ-R test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypertonic saline', 'cystic fibrosis', 'pulmonary inflammation', 'pulmonary exacerbation'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Cystic fibrosis\n* Over 6 years old\n* FEV1 over than 30%\n* Must be able to perform a spirometry\n* Must be able to perform induced sputum\n* Must tolerate the maximum dose of 10 ml hypertonic saline\n* No oral neither intravenous treatment within the previous 2 weeks before the beginning of the study\n* No treatment with hypertonic saline in the 2 weeks before\n\nExclusion Criteria:\n\n* No clinical diagnosis of Cystic Fibrosis\n* No tolerance of 10 ml of hypertonic saline\n* Positive pregnancy test\n* No tolerance of Beta2-agonist\n* Treatment with corticosteroids\n* FEV1 \\< 30%\n* Liver and/or lung transplantation\n* Oxygen treatment\n* Hospital admission within the 4 previous weeks\n* Oral or intravenous antibiotic treatment within the 2 previous weeks\n* Smokers\n* Pulmonary colonisation with Burkholderia cepacia complex'}, 'identificationModule': {'nctId': 'NCT01377792', 'briefTitle': 'Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'SSH-FQ1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '5 ml', 'interventionNames': ['Drug: Hypertonic saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10 ml', 'interventionNames': ['Drug: Hypertonic saline']}], 'interventions': [{'name': 'Hypertonic saline', 'type': 'DRUG', 'description': 'comparison of different dosages of drug', 'armGroupLabels': ['10 ml', '5 ml']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Cystic Fibrosis Unit. Ramón y Cajal University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Adelaida Lamas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adelaida Lamas Ferreiro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dra.Adelaida Lamas Ferreiro', 'investigatorFullName': 'Adelaida Lamas Ferreiro', 'investigatorAffiliation': 'Hospital Universitario Ramon y Cajal'}}}}