Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-04 @ 4:51 PM
Study NCT ID:
NCT01848769
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2013-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C048053', 'term': 'alpha-ketoisovalerate dehydrogenase phosphatase'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2013-05-03', 'studyFirstSubmitQcDate': '2013-05-03', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'B17MP AUC0-t', 'timeFrame': 'pre-dose until 8hours post dose', 'description': 'B17MP (active metabolite of BDP) systemic exposure as AUC0-t'}], 'secondaryOutcomes': [{'measure': 'B17MP PK profile', 'timeFrame': 'pre-dose until 8 hours post-dose'}, {'measure': 'BDP PK prolile', 'timeFrame': 'Pre-dose until 8 hours post-dose'}, {'measure': 'Formoterol PK profile', 'timeFrame': 'Pre-dose until 8 hours post-dose'}, {'measure': 'Plasma potassium AUC, Cmin, tmin', 'timeFrame': 'Pre-dose until 8 hours post-dose', 'description': 'Plasma potassium to evaluate drug systemic effect'}, {'measure': 'Urinary Cortisol excretion', 'timeFrame': 'Pre-dose until 8 hours post-dose', 'description': '8h urinary excretion of cortisol and 8h urinary excretion of cortisol normalized for 8h creatinine excretion to evaluate dru systemic effects'}, {'measure': 'Glucose in urine', 'timeFrame': 'Pre-dose until 8 hours post-dose', 'description': 'Glucose to evaluate the drug systemic effects'}, {'measure': 'Heart rate Time averaged heart rate value (AUC0-t)/t', 'timeFrame': 'Pre-dose until 8 hours post-dose', 'description': 'Heart rate to evaluate the drug systemic effects'}, {'measure': 'Spirometry: PEF', 'timeFrame': 'Pre-dose until 8 hours post-dose', 'description': 'Peak respiratory flow as a measure of drug efficacy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'ICS+LABA', 'Children', 'Inhalation', 'pMDI'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '24746942', 'type': 'BACKGROUND', 'citation': 'Govoni M, Piccinno A, Lucci G, Poli G, Acerbi D, Baronio R, Singh D, Kuna P, Chawes BL, Bisgaard H. The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015 Feb;30:102-9. doi: 10.1016/j.pupt.2014.04.003. Epub 2014 Apr 16.'}, {'pmid': '22978252', 'type': 'RESULT', 'citation': 'Chawes BL, Piccinno A, Kreiner-Moller E, Vissing NH, Poorisrisak P, Mortensen L, Nilson E, Bisgaard A, Dossing A, Deleuran M, Skytt NL, Samandari N, Sergio F, Ciurlia G, Poli G, Acerbi D, Bisgaard H. Pharmacokinetic comparison of inhaled fixed combination vs. the free combination of beclomethasone and formoterol pMDIs in asthmatic children. Br J Clin Pharmacol. 2013 Apr;75(4):1081-8. doi: 10.1111/j.1365-2125.2012.04459.x.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/search?query=2009-010434-22', 'label': 'Study Record on EU Clinical Trials Register including results'}]}, 'descriptionModule': {'briefSummary': 'The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/Female children aged 5-11 years\n* Written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting).\n* children with stable asthma on regular treatment with ICS or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms\n* Forced expiratory volume in one second (FEV1) \\> 70% of predicted values (% pred) after withholding beta2-agonist treatment for a minimum of 4 h prior to each dose period.\n\n 6\\. A cooperative attitude and ability to be trained about the proper use of pMDI with a spacer device and compliant to study procedures.\n\nExclusion Criteria:\n\n* Past or present diagnoses of cardiovascular, renal or liver disease\n* Known hypersensitivity to the active treatments\n* Exacerbation of asthma symptoms within the previous 4 weeks\n* Inability to perform the required breathing technique and blood sampling\n* Hospitalization due to exacerbation of asthma within 1 month prior to inclusion\n* Lower respiratory tract infection within 1 month prior to inclusion\n* Disease (other than asthma) which might influence the outcome of the study\n* Obesity, i.e. \\> 97% weight percentile by local standards'}, 'identificationModule': {'nctId': 'NCT01848769', 'acronym': 'PAED1', 'briefTitle': 'Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'A Single-dose, Open-Label, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI (Fixed Combination Of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6 µg) Using The Aerochamber Plus™ Spacer Device Versus The Free Combination Of Beclomethasone HFA pMDI And Formoterol HFA pMDI Available On The Market Using The Aerochamber Plus™ Spacer Device In Asthmatic Children', 'orgStudyIdInfo': {'id': 'CCD-0902-PR-0013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHF1535 pMDI + AC Plus', 'description': 'Fixed combination of Beclomethasone Dipropionate and Formoterol 50/6 mcg with Aerochamber Plus spacer device', 'interventionNames': ['Drug: CHF1535 pMDI + AC Plus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BDP and Formoterol + AC Plus', 'description': 'Beclomethasone Dipropionate 50 mcg and Formoterol 6 mcg with Aerochamber Plus spacer device', 'interventionNames': ['Drug: BDP + AC Plus', 'Drug: Formoterol + AC Plus']}], 'interventions': [{'name': 'CHF1535 pMDI + AC Plus', 'type': 'DRUG', 'otherNames': ['Fixed combination of BDP and FF 50/6 mcg'], 'description': 'Four inhalations for a total dose of BDP/FF 200/24 mcg', 'armGroupLabels': ['CHF1535 pMDI + AC Plus']}, {'name': 'BDP + AC Plus', 'type': 'DRUG', 'otherNames': ['Beclomethasone Dipropionate 50 mcg with Aerochamber Plus'], 'description': 'Four inhalations for a total dose of BDP 200 mcg', 'armGroupLabels': ['BDP and Formoterol + AC Plus']}, {'name': 'Formoterol + AC Plus', 'type': 'DRUG', 'otherNames': ['Formoterol 6 mcg with Aerochamebr Plus'], 'description': 'Four inhalations for a total dose of Formoterol 24 mcg', 'armGroupLabels': ['BDP and Formoterol + AC Plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'BorneAstmaKlinikken', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Hans Bisgaard, MD DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BorneAstmaKlinikken'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}