Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00174720
Status:
COMPLETED
Last Update Posted:
2009-04-08
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C120481', 'term': 'ciclesonide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 708}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-07', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to Week 16 in FEV1'}], 'secondaryOutcomes': [{'measure': 'Symptom scores, rescue albuterol use and morning peak flow measurements'}]}, 'conditionsModule': {'keywords': ['Glucocorticosteroid. Bronchospasm'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '19549432', 'type': 'DERIVED', 'citation': 'Berger WE, Kerwin E, Bernstein DI, Pedinoff A, Bensch G, Karafilidis J. Efficacy and safety evaluation of ciclesonide in subjects with mild-to-moderate asthma not currently using inhaled corticosteroids. Allergy Asthma Proc. 2009 May-Jun;30(3):304-14. doi: 10.2500/aap.2009.30.3242.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy of ciclesonide MDI either as once daily or twice daily in patients with mild to moderate asthma, who have not previously been treated with an inhaled corticosteroid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females 12 years or older\n* History of persistent bronchial asthma for at least 6 months\n* Documented use of bronchodilators (short acting only) only or methylxanthines for at least 1 month before screening\n* At screening, FEV1 60 to 90% of predicted. Reversibility of FEV1 by at least 12% post-bronchodilator\n* Be able to use oral inhalers\n* Non-smokers\n\nExclusion Criteria:\n\n* History of life-threatening asthma\n* Other pulmonary diseases\n* URI within 4 weeks before screening\n* Use of systemic steroids within 6 months before screening. Use of inhaled steroids within 30 days before screening. More than 2 in-patient hospitalizations or ER visits due to asthma exacerbations in the prior year before screening\n* Pregnant or breast-feeding females\n* Females of child-bearing potential not using adequate means of birth control\n* Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease\n* Abnormal clinical laboratory parameters that would limit participation in the study or interfere with interpretation of study results\n* History of drug or alcohol abuse\n* Treatment with any investigational product within 30 days prior to study entry'}, 'identificationModule': {'nctId': 'NCT00174720', 'briefTitle': 'Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multinational,Multicenter,Randomized,Double-Blind,Placebo-Controlled,Parallel-Group Study to Assess the Efficacy of Ciclesonide Metered-Dose Inhaler at a Daily Dose of 160 μg Administered Either in a Once-Daily in the Morning Regimen (160 μg qd AM) for 16 Weeks or in a 160 μg qd AM Regimen for 12 Weeks Preceded by a Twice-Daily Regimen (80 μg Bid) for 4 Weeks,or in an 80 μg Bid Regimen for 16 Weeks,in Adults and Adolescents With Mild to Moderate Persistent Asthma Not Treated With Steroids', 'orgStudyIdInfo': {'id': 'EFC6164'}, 'secondaryIdInfos': [{'id': 'XRP1526B/3031'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ciclesonide (XRP1526)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'San José', 'country': 'Costa Rica', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Netanya', 'country': 'Israel', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}