Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT00163332
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-12-02', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(0-24h)/24 h of serum cortisol level'}, {'measure': '24 h urinary cortisol excretion adjusted for creatinine.'}], 'secondaryOutcomes': [{'measure': '8 am measurement of bone formation markers'}, {'measure': 'PC20FEV1 to methacholine'}, {'measure': 'PC20FEV1 to AMP'}, {'measure': 'lung function (FEV1, FVC)'}, {'measure': 'pharmacokinetics'}, {'measure': 'safety and tolerability.'}]}, 'conditionsModule': {'keywords': ['Asthma', 'Ciclesonide', 'Fluticasone propionate'], 'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4517&filename=BY9010-MI-129-RDS-2007-04-25.pdf', 'label': 'BY9010-MI-129-RDS-2007-04-25.pdf'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Patients who have had a history of bronchial asthma for at least 6 months\n* FEV1 \\>60% of predicted for at least 24 h\n* Patients who are hyperresponsive to methacholine and to AMP\n* Patients who are in good health with the exception of asthma\n\nMain Exclusion Criteria:\n\n* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids\n* Patients suffering from COPD and/or other relevant lung diseases except asthma\n* Current smokers and ex-smokers both with ≥10 pack years'}, 'identificationModule': {'nctId': 'NCT00163332', 'briefTitle': 'Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Comparison of Inhaled Ciclesonide (160 mcg b.i.d. or 320 mcg b.i.d.) and Fluticasone Propionate (250 mcg b.i.d. or 500 mcg b.i.d.) in Pretreated Patients With Mild to Moderate Asthma', 'orgStudyIdInfo': {'id': 'BY9010/M1-129'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ciclesonide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'country': 'Belgium', 'facility': 'Altana Pharma/Nycomed', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Altana Pharma/Nycomed', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3620', 'city': 'Lanaken', 'country': 'Belgium', 'facility': 'Altana Pharma/Nycomed', 'geoPoint': {'lat': 50.89318, 'lon': 5.6468}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Altana Pharma/Nycomed', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '4000', 'city': 'Liége', 'country': 'Belgium', 'facility': 'Altana Pharma/Nycomed'}], 'overallOfficials': [{'name': 'AstraZeneca AstraZeneca', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}