Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-06 @ 12:20 AM
Study NCT ID:
NCT00862394
Status:
COMPLETED
Last Update Posted:
2018-04-13
First Post:
2009-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma
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': 'D005581', 'term': 'Foster Home Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 783}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2009-03-13', 'studyFirstSubmitQcDate': '2009-03-13', 'lastUpdatePostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline measured at clinic to the end of treatment period in pre-dose morning FEV1 (L) measured at clinic', 'timeFrame': '3 month period'}], 'secondaryOutcomes': [{'measure': 'Pre-dose FEV1', 'timeFrame': 'every month'}, {'measure': 'Post-dose FEV1 AUC 0-8 h', 'timeFrame': '3 month period'}, {'measure': 'FVC and FEF 25-75%', 'timeFrame': 'every month'}, {'measure': 'PEF', 'timeFrame': 'every day'}, {'measure': 'Morning and evening asthma clinical symptoms scores', 'timeFrame': 'every day'}, {'measure': 'Moderate and severe exacerbations', 'timeFrame': 'every month'}, {'measure': 'Rescue medication', 'timeFrame': 'every day'}, {'measure': 'Sputum', 'timeFrame': '3 month period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/search?query=CCD-0705-PR-0027', 'label': 'Study Record on EU Clinical Trials Register including results'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Outpatients of both sexes, aged \\> 12 years\n* Moderate to severe symptomatic asthma\n* Forced expiratory volume in the first second (FEV1) \\> 40% and \\< 80% of the predicted normal values\n* Reversibility test\n* "Partly controlled" asthma (GINA revised 2006)\n* Patients free of long-acting beta2-agonists (LABAs) treatment\n* Under inhaled corticosteroids (ICS) treatment\n* A minimum inspiratory flow ≥ 40 L/min 10.\n* Non-smokers or ex smokers\n* Asthma Control Questionnaire ACQ score ≥ 1.5\n\nExclusion Criteria:\n\n* Pregnant or nursing (lactating) women\n* Women of child-bearing potential, UNLESS they are menopausal or have acceptable methods of contraception\n* Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer\n* History of near fatal asthma\n* Occurrence of asthma exacerbations or respiratory tract infections in the 6 weeks preceding the screening visit\n* Diagnosis COPD\n* History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency\n* Diagnosis of restrictive lung disease\n* Patients treated with oral or parenteral corticosteroids in the previous 2 months (3 months for parenteral depot corticosteroids)\n* Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids\n* Allergy to any component of the study treatments\n* Any change in the dose, schedule, formulation or product of an inhaled corticosteroid in the 4 weeks prior to screening visit\n* Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality ;\n* Patients with abnormal QTc'}, 'identificationModule': {'nctId': 'NCT00862394', 'briefTitle': 'A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'A 12-week, Multinational, Randomised, Double Blind, Double Dummy, 4-arm Parallel-group Study Comparing the Efficacy and Safety of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation, Via HFA Pressurised Inhalation Solution, in Moderate to Severe Symptomatic Asthmatic Patients Aged ≥ 12 Years Under Treatment With Inhaled Corticosteroids', 'orgStudyIdInfo': {'id': 'CCD-0705-PR-0027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'CHF 1535 Next DPI : BDP/Formoterol : 200/12 µg', 'interventionNames': ['Drug: BDP/Formoterol Next DPI']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'CHF 1535 HFA pMDI : BDP/Formoterol : 200/12 µg', 'interventionNames': ['Drug: Foster']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'CHF 1535 Next DPI : BDP/Formoterol : 400/24 µg', 'interventionNames': ['Drug: BDP/Formoterol Next DPI']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'CHF 1535 HFA pMDI : BDP/Formoterol : 400/24 µg', 'interventionNames': ['Drug: Foster']}], 'interventions': [{'name': 'BDP/Formoterol Next DPI', 'type': 'DRUG', 'description': 'BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)', 'armGroupLabels': ['1']}, {'name': 'Foster', 'type': 'DRUG', 'description': 'BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)', 'armGroupLabels': ['2']}, {'name': 'BDP/Formoterol Next DPI', 'type': 'DRUG', 'description': 'BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)', 'armGroupLabels': ['3']}, {'name': 'Foster', 'type': 'DRUG', 'description': 'BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Oliver Kornmann - National Coordinator in Germany', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}