Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-05-23 @ 10:06 AM
Study NCT ID:
NCT03900195
Status:
UNKNOWN
Last Update Posted:
2019-04-02
First Post:
2019-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-30', 'studyFirstSubmitDate': '2019-01-20', 'studyFirstSubmitQcDate': '2019-03-30', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced expiratory volume in the first minute', 'timeFrame': '6 months after intervention', 'description': 'Pulmonary function tests that are done with a spirometry to measure forced expiratory volume'}], 'secondaryOutcomes': [{'measure': '6 minute walking test', 'timeFrame': '6 months after intervention', 'description': '6 minute walking test is a field test that measures the distance a patient walks during a 6 minute period.'}, {'measure': "St. George's Quality of Life Score", 'timeFrame': '6 months after intervention', 'description': 'Scores are calculated for three domains:\n\nSymptoms, Activity and Impacts (Psycho-social) as well as a total score.\n\nPsychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials.\n\nA minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. This score has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The effectiveness of Bottle PEP in patients with Chronic Obstructive Pulmonary Disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with COPD\n* Stable Disease\n\nExclusion Criteria:\n\n* Neuromuscular disease\n* Recent pneumothorax\n* Major surgery in the last 6 months'}, 'identificationModule': {'nctId': 'NCT03900195', 'briefTitle': 'The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '09.2019.052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bottle PEP', 'description': 'Bottle PEP is a positive expiratory system that is applied via a tube of more than 5 mm of thickness and a bottle filled with water about 10 cms.', 'interventionNames': ['Other: BottlePEP']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No interventions will be applied.'}], 'interventions': [{'name': 'BottlePEP', 'type': 'OTHER', 'description': 'Positive expiratory device with a bottle', 'armGroupLabels': ['Bottle PEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34899', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ozge Kenis-Coskun, MD', 'role': 'CONTACT', 'email': 'ozgekenis@gmail.com', 'phone': '5058294947'}, {'name': 'MD', 'role': 'CONTACT'}], 'facility': 'Marmara University School of Medicine Department of Physical Medicine and Rehabilitation', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Ozge Kenis Coskun, Asisstant Prof.', 'role': 'CONTACT', 'email': 'ozgekenis@gmail.com', 'phone': '+905058294947'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}