Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT05904002
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2023-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Incentive Spirometery on Asthmatic Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2023-06-02', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the change in lung functions', 'timeFrame': 'at baseline and after 6 weeks of intervention', 'description': 'The spirometer will be used for assessment of lung functions including total lung capacity (TLC) (litre), which is the most widely used functional index in the asthma follow up.'}, {'measure': 'Assessing the change in symptoms of asthma', 'timeFrame': 'at baseline and after 6 weeks of intervention', 'description': 'The Asthma Control Test provides a numerical score to help you and your healthcare provider determine if your asthma symptoms are well controlled. Take this test if you are 12 years or older. Share the score with your healthcare provider.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthmatic', 'Pregnant With Complication']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of the incentive spirometer on asthma during pregnancy.', 'detailedDescription': "This study will provide an evidence basis for obstetricians and physical therapist for women's health about the effect of spirometry on asthma during pregnancy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patients will have the following criteria:\n\n1. Their age will range from 30 to40years old.\n2. Body mass index (BMI) will range from 25-29.9 kg/m2.\n3. All patients will be clinically and medically stable.\n\nExclusion Criteria:\n\nPatients will be excluded from the study if they have the following:\n\n1. Diabetes mellitus.\n2. Severe hypertension.\n3. Neurological and neuromuscular disorders.\n4. Blindness.\n5. Developed moderate and severe degree of pleural effusion.\n6. Cardiovascular instability.\n7. Chronic chest disease.'}, 'identificationModule': {'nctId': 'NCT05904002', 'briefTitle': 'Effect of Incentive Spirometery on Asthmatic Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Incentive Spirometery on Asthmatic Pregnant Women', 'orgStudyIdInfo': {'id': 'Eman_Amin_2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pulmicort inhaler', 'description': 'Group (A) consists of 30 patients. They will receive their inhaled glucocorticoids (pulmicort inhaler) on needs.', 'interventionNames': ['Drug: pulmicort inhaler']}, {'type': 'EXPERIMENTAL', 'label': 'incentive spirometer', 'description': 'Group (B) consists of 30 patients. They will receive the same medical treatment and incentive spirometer program 3 days per week for six weeks.', 'interventionNames': ['Drug: pulmicort inhaler', 'Device: Incentive spirometer treatment']}], 'interventions': [{'name': 'pulmicort inhaler', 'type': 'DRUG', 'description': 'Each woman in both groups (A\\&B) will receive pulmicort inhaler on needs.', 'armGroupLabels': ['incentive spirometer', 'pulmicort inhaler']}, {'name': 'Incentive spirometer treatment', 'type': 'DEVICE', 'description': 'Each patient in group B will be instructed about the effects of incentive spirometer to gain their cooperation during the study course.', 'armGroupLabels': ['incentive spirometer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dokki', 'country': 'Egypt', 'facility': 'Outpatient clinic faculty of physical therapy cairo university', 'geoPoint': {'lat': 30.03823, 'lon': 31.2113}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eman Amin Soliman', 'investigatorAffiliation': 'Cairo University'}}}}