Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 5:42 PM
Study NCT ID:
NCT02303808
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2014-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positive Expiratory Pressure During Inhalation of 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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2014-11-25', 'studyFirstSubmitQcDate': '2014-11-28', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wet sputum production', 'timeFrame': '45 minutes', 'description': 'Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)'}], 'secondaryOutcomes': [{'measure': 'Wet sputum production', 'timeFrame': '2 hours', 'description': '2 hours wet sputum production (ml) after chest physiotherapy session'}, {'measure': 'Wet sputum production', 'timeFrame': '22 hours', 'description': '22 hours wet sputum production (ml) after chest physiotherapy session'}, {'measure': 'Lung function (simply spirometry)', 'timeFrame': '5 days', 'description': 'Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75'}, {'measure': 'Safety and tolerability of session (Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate)', 'timeFrame': '45 minutes', 'description': 'Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate'}, {'measure': "Patient's perception (Likert test)", 'timeFrame': '5 days', 'description': 'Likert test'}, {'measure': 'Questionnaire', 'timeFrame': '5 days', 'description': 'Leicester Cough Questionnaire (LCQ) and Cough and sputum Questionnaire (C\\&S)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hyperosmolar agents', 'Hypertonic saline', 'Airway clearance techniques', 'Positive Expiratory Pressure', 'Autogenic drainage'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '37319354', 'type': 'DERIVED', 'citation': 'Wark P, McDonald VM, Smith S. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD001506. doi: 10.1002/14651858.CD001506.pub5.'}, {'pmid': '32026826', 'type': 'DERIVED', 'citation': 'San Miguel-Pagola M, Reychler G, Cebria I Iranzo MA, Gomez-Romero M, Diaz-Gutierrez F, Herrero-Cortina B. Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial. Physiotherapy. 2020 Jun;107:243-251. doi: 10.1016/j.physio.2019.11.001. Epub 2019 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).', 'detailedDescription': "All patients will perform two different arms of treatment in a crossover randomization. Each arm of treatment will be applied during 5 consecutive days. The wash-out period will be one week. Before starting the trial all patients will do an inhalation formation.\n\nDuring the study period the patients' pharmacological treatment remains unchanged"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pass the inhalation test\n* Chronic sputum production, at least ≥ 10 ml /24h\n* Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium\\>70 mmol/l or sweat chloride of\\>60 mmol/l)\n* Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks)\n* Trained in the use of autogenic drainage technique (at least 6 months)\n* Inhaling hypertonic saline since at least 6 months\n* To be able to provide written, informed consent and perform the protocol and the evaluations\n\nExclusion Criteria:\n\n* Active massive hemoptysis during the previous 2 months\n* Patient in transplantation or retransplantation list\n* Patient already participating in another study at the same time'}, 'identificationModule': {'nctId': 'NCT02303808', 'briefTitle': 'Positive Expiratory Pressure During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad San Jorge'}, 'officialTitle': 'Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.', 'orgStudyIdInfo': {'id': 'FQ_INH_PEP_01'}, 'secondaryIdInfos': [{'id': '239|2012', 'type': 'OTHER_GRANT', 'domain': 'SEPAR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'USUAL CARE', 'description': 'Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'INHALATION WITH PEP DEVICE', 'description': 'Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) combined with a PEP device (Acapella Duet) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes.', 'interventionNames': ['Device: INHALATION WITH PEP DEVICE (Acapella Duet)']}], 'interventions': [{'name': 'INHALATION WITH PEP DEVICE (Acapella Duet)', 'type': 'DEVICE', 'description': 'Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.', 'armGroupLabels': ['INHALATION WITH PEP DEVICE']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Asociación Aragonesa de Fibrosis Quística', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Marta San Miguel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad San Jorge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad San Jorge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}