Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-28 @ 7:21 PM
Study NCT ID:
NCT00476268
Status:
COMPLETED
Last Update Posted:
2024-10-31
First Post:
2007-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent 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': 'D001507', 'term': 'Beclomethasone'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 824}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2007-05-18', 'studyFirstSubmitQcDate': '2007-05-18', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-dose morning PEF', 'timeFrame': 'End of treatment'}], 'secondaryOutcomes': [{'measure': 'Pre-dose FEV1', 'timeFrame': 'At clinic visits'}, {'measure': 'Other spirometric parameters', 'timeFrame': 'At clinic visits'}, {'measure': 'Morning and evening asthma clinical symptom scores', 'timeFrame': 'End of treatment'}, {'measure': 'Percentage of night and/or days free of clinical symptoms', 'timeFrame': 'End of treatment'}, {'measure': 'Use of rescue short-acting b2-agonists', 'timeFrame': 'End of treatment'}, {'measure': 'Asthma exacerbations', 'timeFrame': 'end of treatment'}, {'measure': 'safety and tolerability', 'timeFrame': 'end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '18977646', 'type': 'RESULT', 'citation': 'Huchon G, Magnussen H, Chuchalin A, Dymek L, Gonod FB, Bousquet J. Lung function and asthma control with beclomethasone and formoterol in a single inhaler. Respir Med. 2009 Jan;103(1):41-9. doi: 10.1016/j.rmed.2008.09.002. Epub 2008 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.', 'detailedDescription': 'The purpose of this study is to evaluate the efficacy and tolerability of beclometasone/formoterol single inhaler in a twice daily regimen in patients with moderate to severe persistent asthma. Patients are randomised to receive either beclometasone/formoterol single inhaler (total daily dose: BDP/FF 400/24 mcg) or beclometasone CFC + formoterol DPI (total daily dose: BDP 1000 mcg + FF 24 mcg) or beclometasone CFC (total daily dose: BDP 1000 mcg) during 24 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of moderate to severe persistent asthma (according to GINA 2002 guidelines)\n* FEV1 \\> 40% and \\< 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)\n* Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of:\n\n 750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs)\n* Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms \\> 3 times in the week prior to inclusion\n* A documented positive response to the reversibility test.\n\nExclusion Criteria:\n\n* Pregnant or lactating females or women of childbearing potential without any efficient contraception.\n* Heavy smokers defined as smoking for \\> 10 pack years.\n* Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids).\n* Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer.\n* Clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.\n* Patients with an abnormal QTc interval value in the ECG test, defined as \\> 450 msec in males or \\> 470 msec in females.\n* Evidence of asthma worsening during the week preceding randomisation (e.g. PEF variability \\> 30% during 2 consecutive days, SABA use \\> 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days'}, 'identificationModule': {'nctId': 'NCT00476268', 'briefTitle': 'Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'A 24-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Moderate to Severe Persistent Asthma', 'orgStudyIdInfo': {'id': 'DM/PR/033011/003/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'beclometasone /formoterol', 'description': 'beclomethasone dipropionate 100 µg plus formoterol 6 µg pMDI', 'interventionNames': ['Drug: beclomethasone/formoterol (100/6µg) pMDI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Beclomethasone', 'description': 'Beclomethasone dipropionate (BecotideTM) 250 µg/unit dose pMDI aerosol via CFC propellant.', 'interventionNames': ['Drug: Beclometasone dipropionate 250 µg/unit dose pMDI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Formoterol powder 12 µg/unit dose', 'description': 'Formoterol powder 12 µg/unit dose (Foradil™)', 'interventionNames': ['Drug: Formoterol powder 12 µg/unit dose']}], 'interventions': [{'name': 'beclomethasone/formoterol (100/6µg) pMDI', 'type': 'DRUG', 'description': 'Two puffs b.i.d', 'armGroupLabels': ['beclometasone /formoterol']}, {'name': 'Beclometasone dipropionate 250 µg/unit dose pMDI', 'type': 'DRUG', 'otherNames': ['BecotideTM'], 'description': '2 inhalations bid', 'armGroupLabels': ['Beclomethasone']}, {'name': 'Formoterol powder 12 µg/unit dose', 'type': 'DRUG', 'otherNames': ['Foradil™'], 'description': '2 inhalations bid', 'armGroupLabels': ['Formoterol powder 12 µg/unit dose']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Francoise Bonnet-Gonod', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chiesi Farmaceutici'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}