Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT00889967
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2009-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"
Sponsor:
Organization:
Raw JSON
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Quality of life (QOL) 5. Safety and tolerability', 'timeFrame': '28 days'}, {'measure': 'Quality of life (QOL)', 'timeFrame': '28 days'}, {'measure': 'Safety and tolerability', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pseudomonas aeruginosa', 'antimicrobial', 'inhalation', 'ciprofloxacin', 'Non-Cystic Fibrosis Bronchiectasis'], 'conditions': ['Non-Cystic Fibrosis Bronchiectasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Are willing and able to provide written informed consent.\n2. Are males or females 18 to 80 year of age, inclusive.\n3. Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years.\n4. Confirmation of infection with P. aeruginosa at screening\n\nExclusion Criteria:\n\n1. Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics.\n2. Have an exacerbation during the Screening Phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug.\n3. Have a diagnosis of cystic fibrosis..\n4. Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1:\n\n * Azithromycin\n * Hypertonic saline\n * Bronchodilator medications\n * Oral corticosteroid.\n5. Have received an investigational drug or device within 28 days prior to Visit 1.\n6. Have any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patients' treatment, assessment, or compliance with the protocol."}, 'identificationModule': {'nctId': 'NCT00889967', 'briefTitle': 'Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aradigm Corporation'}, 'officialTitle': 'An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis', 'orgStudyIdInfo': {'id': 'ARD-3100-0901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Ciprofloxacin for Inhalation 100 mg/day by inhalation', 'interventionNames': ['Drug: Ciprofloxacin for Inhalation']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Ciprofloxacin for inhalation 150 mg/day by inhalation', 'interventionNames': ['Drug: Ciprofloxacin for Inhalation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo by inhalation', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ciprofloxacin for Inhalation', 'type': 'DRUG', 'description': '100 mg once daily by inhalation for 28 days', 'armGroupLabels': ['1']}, {'name': 'Ciprofloxacin for Inhalation', 'type': 'DRUG', 'description': '150 mg once daily by inhalation for 28 days', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily by inhalation for 28 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, 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Kingdom', 'facility': '"Northumbria Healthcare'}], 'overallOfficials': [{'name': 'Paul Bruinenberg, MBChB, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aradigm Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aradigm Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}