Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT00251056
Status:
COMPLETED
Last Update Posted:
2008-08-29
First Post:
2005-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mannitol Dose Response Study in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008353', 'term': 'Mannitol'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-27', 'studyFirstSubmitDate': '2005-06-30', 'studyFirstSubmitQcDate': '2005-11-07', 'lastUpdatePostDateStruct': {'date': '2008-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1', 'timeFrame': '2 weeks'}, {'measure': 'FVC', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'other measures of lung function', 'timeFrame': 'various'}, {'measure': 'QOL', 'timeFrame': '2 weeks'}, {'measure': 'sputum microbiology', 'timeFrame': '2 weeks'}, {'measure': 'safety', 'timeFrame': '2 weeks'}, {'measure': 'sputum clearance and cough', 'timeFrame': '2 weeks'}, {'measure': 'respiratory symptoms', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology and replenishing the airway surface liquid layer in these patients, thereby enhancing the shift of stagnant mucus from the lungs. The study aim is to determine the optimal dose of mannitol to generate clinical improvement in patients with cystic fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cystic fibrosis (sweat test/genotype)\n* 7 years or older\n* FEV1 between 40% and 90% of predicted for height, age and gender.\n* Able to perform acceptable-quality spirometry\n* Clinically stable in the week up to study entry\n* No additional antibiotics or additional oral steroids for a period of 14 days before study entry (routine antibiotics permitted)\n\nExclusion Criteria\n\n* Currently active asthma\n* Subjects colonized with Burkholderia cepacia or MRSA\n* Considered "terminally ill" or listed for transplantation\n* Requiring home oxygen or assisted ventilation\n* Concurrent illness that in the investigators opinion may contribute to an increased and unacceptable risk if the subject was enrolled in the study (e.g. significant varicies, portal hypertension, cor pulmonale)\n* Significant episode of haemoptysis (\\>60 mLs) in the previous 12 months\n* Heart attack or stroke in last 3 months\n* Known aortic or cerebral aneurysm\n* Subjects who are breast feeding or pregnant.\n* At risk females unwilling to use appropriate contraception to prevent pregnancy during the course of the study\n* Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.\n* Known intolerance to mannitol or unable to take any form of bronchodilator medications.\n* Uncontrolled hypertension, systolic BP \\> 200 or diastolic BP\\> than 100\n* Concurrent use of beta blocker medication\n* Concurrent use of hypertonic saline\n\nCanada:\n\n* Concurrent use of other pharmacological mucolytic agents other than Pulmozyme\n\nArgentina:\n\n* Concurrent use of other pharmacological mucolytic agents including Pulmozyme'}, 'identificationModule': {'nctId': 'NCT00251056', 'briefTitle': 'Mannitol Dose Response Study in Cystic Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Syntara'}, 'officialTitle': 'A Phase IIa Randomised, Open Label, Dose Response Study to Determine the Optimum Dose of Dry Powder Mannitol Required to Generate Clinical Improvement In Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'DPM-CF-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: mannitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: mannitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: mannitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: mannitol']}], 'interventions': [{'name': 'mannitol', 'type': 'DRUG', 'description': '120mg BD', 'armGroupLabels': ['2']}, {'name': 'mannitol', 'type': 'DRUG', 'description': '40 mg BD', 'armGroupLabels': ['1']}, {'name': 'mannitol', 'type': 'DRUG', 'description': '240mg BD', 'armGroupLabels': ['3']}, {'name': 'mannitol', 'type': 'DRUG', 'description': '400mg BD', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B1904CSI', 'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital de Niños Superiora Sor María Ludovica', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'city': 'Resistencia', 'state': 'Chaco Province', 'country': 'Argentina', 'facility': 'Hospital Pediatrico', 'geoPoint': {'lat': -27.46363, 'lon': -58.98665}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Interzonal Especializado Materno Infantil (HIEMI)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'CABA', 'country': 'Argentina', 'facility': 'Hospital General de Niños'}, {'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Hospital Pediatrico Dr Humberto J Notti', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'St Pauls Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': "Janeway Children's Health and Rehabilitation Center", 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences Corporation', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'St Michaels Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Elizabeth Tullis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Michaels Hospital, Toronto, Ontario, Canada'}, {'name': 'Brett Charlton, MBBS PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pharmaxis Ltd, Sydney, NSW, Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syntara', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Brett Charlton', 'oldOrganization': 'Pharmaxis Ltd'}}}}