Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT00163358
Status:
COMPLETED
Last Update Posted:
2016-11-30
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)
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': 'PARALLEL'}, 'enrollmentInfo': {'count': 630}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time until the first severe asthma exacerbation occurs'}, {'measure': 'number of poorly controlled asthma days.'}], 'secondaryOutcomes': [{'measure': 'percentage of days with asthma control'}, {'measure': 'percentage of days with asthma symptoms'}, {'measure': 'percentage of nocturnal awakenings due to asthma'}, {'measure': 'asthma symptom score'}, {'measure': 'number of inhalations of rescue medication'}, {'measure': 'proportion of patients with severe asthma exacerbations'}, {'measure': 'differences in morning PEF from diary'}, {'measure': 'differences in FEV1 and FVC from spirometry'}, {'measure': 'blood eosinophils'}, {'measure': 'AQLQ(S)'}, {'measure': 'health economic data'}, {'measure': 'vital signs'}, {'measure': 'laboratory work-up'}, {'measure': 'adverse events.'}]}, 'conditionsModule': {'keywords': ['Asthma', 'Ciclesonide', 'Fluticasone propionate', 'Salmeterol'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '21088114', 'type': 'DERIVED', 'citation': "Postma DS, O'Byrne PM, Pedersen S. Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control. Chest. 2011 Feb;139(2):311-318. doi: 10.1378/chest.09-1735. Epub 2010 Nov 18."}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4520&filename=BY9010-MI-132-RDS-2007-02-12.pdf', 'label': 'BY9010-MI-132-RDS-2007-02-12.pdf'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Clinical diagnosis of mild persistent asthma\n* Pre-treatment with SABAs only\n* FEV1 ≥80% predicted\n* 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* COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function\n* Pregnancy\n* Intention to become pregnant during the course of the study\n* Breast feeding\n* Lack of safe contraception\n* Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years'}, 'identificationModule': {'nctId': 'NCT00163358', 'briefTitle': 'Efficacy of Ciclesonide vs Fixed 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