Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT06820918
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-11
First Post:
2025-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physiotherapy With Positive Expiratory Pressure (PEP) Bottle in Patients With Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the effect of respiratory physiotherapy using a PEP bottle on respiratory function through the measurement of FEV1 (Forced Expiratory Volume in the 1st second)', 'timeFrame': '60 days', 'description': 'To evaluate the effect of respiratory physiotherapy using the PEP bottle on respiratory function in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchiectasis Adult']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether respiratory physiotherapy using the Positive Expiratory Pressure (PEP) bottle has an effect on respiratory function, measured through spirometry, in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject over 18 years of age\n* Confirmed diagnosis of bronchiectasis based on high-resolution chest CT, showing bronchial dilation according to one or more of the following radiological criteria in accordance with the 2019 BTS guidelines.\n* Ratio between the internal lumen of the bronchus and the adjacent pulmonary artery \\>1\n* Absence of normal bronchial tapering\n* Visibility of the airways within 1 cm from the pleura\n* Subject with chronic bronchial hypersecretion (daily secretion ≥ 15ml)\n* Patients capable of performing physiotherapy using the PEP bottle\n* Patients capable of performing global spirometry\n\nExclusion Criteria:\n\n* Subject already undergoing regular respiratory physiotherapy\n* Subject without significant bronchial hypersecretion\n* Concomitant diagnosis of Cystic Fibrosis, Primary Ciliary Dyskinesia, NTM-PD, TB, Sarcoidosis, Active Neoplasia\n* Diagnosis of Asthma according to the 2023 GINA guidelines, defined as documented excessive variability in pulmonary function (positive bronchodilation or bronchoprovocation test with methacholine, or diurnal variability of PEF) + documented limitation of expiratory airflow.\n* Diagnosis of COPD according to the 2023 GOLD guidelines, defined as FEV/FVC post-bronchodilation \\<0.7 on forced spirometry in the presence of suggestive symptoms (dyspnea, chronic cough, sputum production) and/or exposure to risk factors for the disease (e.g., cigarette smoking).\n* Contraindications to PEP-Bottle Physiotherapy (Pneumothorax; Hemoptysis; Myocardial infarction in the 4 weeks prior to informed consent signature)\n* Exacerbation of disease in the previous 4 weeks\n* Use of inhalation therapy in the 4 weeks prior to informed consent signature\n* Active smoker\n* Subject undergoing non-invasive ventilation or with a tracheostomy\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06820918', 'acronym': 'FisioFEV', 'briefTitle': 'Physiotherapy With Positive Expiratory Pressure (PEP) Bottle in Patients With Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Impact of Physiotherapy With Positive Expiratory Pressure (PEP) Bottle on Respiratory Function in Patients With Bronchiectasis (FisioFEV)', 'orgStudyIdInfo': {'id': '6836'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with bronchiectasis', 'interventionNames': ['Device: Bottle PEP']}], 'interventions': [{'name': 'Bottle PEP', 'type': 'DEVICE', 'description': 'Home respiratory physiotherapy using the PEP bottle for a minimum of 10 minutes to a maximum of 30 minutes, twice a day (morning and evening), every day for 30 days', 'armGroupLabels': ['Patients with bronchiectasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'RM', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'RICHELDI LUCA', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}