Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT05299567
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2017-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Azithromycin in Patients With Bronchiolitis Obliterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}], 'ancestors': [{'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Patients were randomly assigned by pharmacy staff in blocks of 4'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo-controlled, double-blind, randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-24'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2011-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-18', 'studyFirstSubmitDate': '2017-05-18', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages change in Forced Expiratory Volume in 1 second (FEV1) Number of Pulmonary exacerbation', 'timeFrame': '6 months', 'description': '1. FEV1 in percentages\n2. Pulmonary exacerbation in numbers'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bronchiolitis obliterans', 'Azithromycin'], 'conditions': ['Bronchiolitis Obliterans']}, 'descriptionModule': {'briefSummary': 'Placebo-controlled, double-blind, randomized study. Post-infectious bronchiolitis obliterans (PIBO) patients aged 5 years and older of both sexes were enrolled.', 'detailedDescription': 'Bronchiolitis obliterans (BO) was defined as the presence of signs and symptoms of chronic obstructive lung disease: A) previously documented acute lower respiratory infection (ALRI) with persistence of airway obstruction and respiratory signs and symptoms, such as: dyspnea, tachypnea, retractions, persistent cough, increased antero-posterior diameter of the chest, persistent wheezing, crackles, exercise intolerance; B) findings such as: hyperinflation, atelectasis, and mosaic oligohemia on CT scan; and C) persistent obstructive pattern on pulmonary function test.\n\nPatients were randomly assigned by pharmacy staff in blocks of 4 to receive either capsules of azithromycin 250 mg (Group 1) or placebo (Group 2) 3 days a week for 6 months. Patients whose weight was less than 40 kg received 250 mg 3 days a week (Monday, Wednesday, and Friday) and those weighing more than 40 kg received 500 mg in the same scheme, according to randomization to active drug or placebo. Pulmonary function and number of exacerbations were evaluated. Spirometry and plethysmography were performed at baseline and at 6 months. Variables analyzed were Forced vital capacity (FVC),Flow expiratory volume at the first second (FEV1), Total lung capacity (TLC),Residual volumen(RV),especific conductance (sGaw). Patients had been clinically stable over the previous three weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of Bronchiolitis obliternas\n* older than 5 years\n* Ability to perform pulmonary function test\n\nExclusion Criteria:\n\n* Not being able to perform lung function study adequately\n* Other causes of chronic lung disease (bronchopulmonary dysplasia, cystic fibrosis, primary or secondary immune deficiency)\n* Previous history of portal hypertension, liver cirrhosis, splenomegaly or chang in normal values of laboratory at the start of the study.\n* History of hypersensitivity to macrolides'}, 'identificationModule': {'nctId': 'NCT05299567', 'briefTitle': 'Efficacy and Safety of Azithromycin in Patients With Bronchiolitis Obliterans', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital JP Garrahan'}, 'officialTitle': 'Double-blind Placebo Trial to Determine the Efficacy and Safety of Treatment With Azithromycin for 6 Months in Patients With Post-infectious Bronchiolitis Obliterans', 'orgStudyIdInfo': {'id': '250463'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'azitrhomycin', 'description': 'Group1 Azitrhomycin 250 or 500 mg in capsuls tree days a week for 6 months if the patiens are less or more than 40 kg respectively Exposure', 'interventionNames': ['Drug: Azithromycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Group 2 placebo Not exposure Placebo in capsuls tree days a week for 6 months', 'interventionNames': ['Drug: Azithromycin']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'Placebo with the same color and size than azithromycin tree days a wek for 6 months', 'armGroupLabels': ['Placebo', 'azitrhomycin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Claudio m Castaños, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Pediatria "juan P. Garrahan"'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claudio Castanos', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Pediatric pulmonology', 'investigatorFullName': 'Claudio Castanos', 'investigatorAffiliation': 'Hospital JP Garrahan'}}}}