Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-04-10 @ 7:32 PM
Study NCT ID:
NCT03145051
Status:
UNKNOWN
Last Update Posted:
2017-09-01
First Post:
2016-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis
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': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2016-11-15', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in quality of life among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution compared to saline solution between inclusion and the end of treatment period.', 'timeFrame': 'over an 8 weeks period', 'description': 'Quality of life to be assessed over an 8 weeks period of nasal wash using SNOT-20 questionnaire'}], 'secondaryOutcomes': [{'measure': 'Clinical status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.', 'timeFrame': 'over an 8 weeks period', 'description': 'Clinical status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Symptomatic Score (LKSS)'}, {'measure': 'Endoscopic status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.', 'timeFrame': 'over an 8 weeks period', 'description': 'Endoscopic status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Endoscopic Score (LKES)'}, {'measure': 'Mucociliary transport change among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.', 'timeFrame': 'over an 8 weeks period', 'description': 'Mucociliary transport to be assessed after 4 and 8 weeks of nasal wash using saccharine test'}, {'measure': 'Evolution of nasal bacterial pathogens among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.', 'timeFrame': 'over an 8 weeks period', 'description': 'Evolution of nasal bacterial pathogens to be assessed by bacteriologic swab within ethmoid nasal cavities after 4 and 8 weeks of nasal wash'}, {'measure': 'Patient treatment acceptance of nasal irrigation with Respimer® Netiflow® medical device', 'timeFrame': 'over an 8 weeks period', 'description': 'Patient treatment acceptance to be assessed by Morisky score after 4 and 8 weeks of nasal wash'}, {'measure': 'Occurrence of adverse events : taste impairment, epistaxis, nasal irritations, nasal burning', 'timeFrame': 'over an 8 weeks period', 'description': 'Adverse events to be assessed based on vigilance tracking during the whole study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['saline solution', 'minerals', 'cystic fibrosis', 'chronic rhinosinusitis', 'nasal irrigation'], 'conditions': ['Chronic Rhinosinusitis', 'Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical device among patients aged ≥ 11 years and older with cystic fibrosis and suffering from chronic rhinosinusitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patient with Cystic Fibrosis with or without lung transplant;\n\n * Patients with allergic chronic rhino sinusitis or no allergic diagnosed by the clinical investigator on the basis of the following signs in variable combination: nasal congestion, headache, sneezing, itchy nose and eyes, runny nose, nosebleeds and nasal crusts, redness and eye discharge present more than 3 months per year.\n * Patient treated on an outpatient basis;\n * Patient agreeing not to take sea baths for the duration of the study;\n * Patient agreeing to respect the procedures for conducting the study, in particular the washout period and follow-up visits;\n * Patient capable of understanding and self-completing the questionnaires;\n * For juvenile patients, the holder (s) of parental authority have accepted the participation of the young person (by signing the informed consent after having taken note of the information note)\n * Member or beneficiary of a social security program\n\nExclusion Criteria:\n\n* Patients with significant obstruction of the nasal passages due to:\n* a mucocele,\n* polyposis causing nasal obstruction\\> 90% or\n* severe malformation of the septum causing a nasal obstruction\\> 90% in whom surgical treatment is recommended;\n\n * Patients with signs of severity that may require hospitalization, such as: severe impairment of general health, dyspnoea with cyanosis, high fever (\\> 40 ° C).\n * Patients requiring corticosteroid therapy during the study, with the exception of patients who received pulmonary transplant and were treated with oral corticosteroids at no more than 0.2 mg / kg / day.\n * Patients with known systemic immunodeficiency status with the exception of patients receiving pulmonary transplantation and immunosuppressed.\n * Patient pregnant (urine test) or without effective contraception (birth control pill, contraceptive patch, contraceptive implant, vaginal ring, intrauterine device or intrauterine device, male condom).\n * Nursing patient.\n * Patient with a contraindication to nasal irrigations as defined in the product leaflet.'}, 'identificationModule': {'nctId': 'NCT03145051', 'acronym': 'Respire', 'briefTitle': 'Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoire de la Mer'}, 'officialTitle': 'Prospective, Randomized, Cross-over, Multicenter, Trial Comparing the Efficacy and Tolerability of Nasal Irrigation With Respimer® Netiflow® Mineral Salts Solution Versus Saline Among Patients With Cystic Fibrosis and Suffering From Chronic Rhinosinusitis', 'orgStudyIdInfo': {'id': 'Laboratoiredelamer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Respimer Netiflow mineral salts solution', 'description': 'Nasal irrigation with Respimer Netiflow mineral salts solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device', 'interventionNames': ['Other: Respimer Netiflow']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline solution', 'description': 'Nasal irrigation with saline solution , 4 times/day during 8 weeks using Respimer Netiflow class I medical device', 'interventionNames': ['Other: Saline solution']}], 'interventions': [{'name': 'Saline solution', 'type': 'OTHER', 'otherNames': ['nasal irrigation care'], 'description': 'a nasal irrigation care', 'armGroupLabels': ['Saline solution']}, {'name': 'Respimer Netiflow', 'type': 'OTHER', 'otherNames': ['nasal irrigation care'], 'description': 'a nasal irrigation care', 'armGroupLabels': ['Respimer Netiflow mineral salts solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire de la Mer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}