Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-05 @ 1:24 AM
Study NCT ID:
NCT02787967
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2016-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-01', 'studyFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2016-05-26', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP', 'timeFrame': 'predose, 15,30min, 1,2,4,6,8 hours post dose', 'description': 'B17MP: Profile of Pharmacokinetics'}], 'secondaryOutcomes': [{'measure': 'B17MP Cmax', 'timeFrame': 'predose, 15min,30min,1,2,4,6,8 hours post dose', 'description': '17MP: profile of pharmacokinetics'}, {'measure': 'BDP Area Under Curve (AUC)', 'timeFrame': 'predose, 15min,30min,1,2,4,6,8 hours post dose', 'description': 'BDP: profile of Pharmacokinetics'}, {'measure': 'Formoterol Area Under Curve (AUC), Cmax, Tmax, T1/2 [', 'timeFrame': 'predose, 15min, 30 min, 1,2,4,6,8 hours postdose', 'description': 'Formoterol: profile of pharmacokinetics'}, {'measure': 'Formoterol Cmax', 'timeFrame': 'predose, 15min, 30 min, 1,2,4,6,8 hours postdose', 'description': 'Formoterol: profile of pharmacokinetics'}, {'measure': 'Formoterol Tmax', 'timeFrame': 'predose, 15min, 30 min, 1,2,4,6,8 hours postdose', 'description': 'Formoterol: profile of pharmacokinetics'}, {'measure': 'Formoterol T1/2', 'timeFrame': 'predose, 15min, 30 min, 1,2,4,6,8 hours postdose', 'description': 'Formoterol: profile of pharmacokinetics'}, {'measure': 'plasma potassium Area Under Curve (AUC)', 'timeFrame': 'predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose', 'description': 'plasma potassium to evaluate drug systemic effect'}, {'measure': 'plasma potassium Cmin', 'timeFrame': 'predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose', 'description': 'plasma potassium to evaluate drug systemic effect'}, {'measure': 'plasma potassium Tmin', 'timeFrame': 'predose, 15min, 30min, 1, 2, 4, 6, 8 hours postdose', 'description': 'plasma potassium to evaluate drug systemic effect'}, {'measure': 'Urinary Cortisol: Amount excreted in 0-8hours (Ae),8h cortisol urinary excretion normalized for 8h creatinine excretion (Ae/Aecreat).', 'timeFrame': 'from predose up to 8 hours postdose', 'description': 'Urinary cortisol to evaluate drug systemic effect'}, {'measure': 'B17MP Tmax', 'timeFrame': 'predose, 15min,30min,1,2,4,6,8 hours post dose', 'description': 'BDP: profile of pharmacokinetics'}, {'measure': 'B17MP T1/2', 'timeFrame': 'predose, 15min,30min,1,2,4,6,8 hours post dose', 'description': 'BDP: profile of pharmacokinetics'}, {'measure': 'BDP Cmax', 'timeFrame': 'predose, 15min,30min,1,2,4,6,8 hours post dose', 'description': 'BDP: profile of pharmacokinetics'}, {'measure': 'BDP Tmax', 'timeFrame': 'predose, 15min,30min,1,2,4,6,8 hours post dose', 'description': 'BDP: profile of pharmacokinetics'}, {'measure': 'BDP T1/2', 'timeFrame': 'predose, 15min,30min,1,2,4,6,8 hours post dose', 'description': 'BDP: profile of pharmacokinetics'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-005152-10/results', 'label': 'Study Record on EU Clinical Trials Register including results'}]}, 'descriptionModule': {'briefSummary': 'The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI', 'detailedDescription': 'This is a pharmacokinetic comparison of NEXThaler 35/4 μg versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/female children with asthma stable enough, according to paediatrician opinion, to allow a wash out period from steroids of 3 days before study treatments.\n* Male/female children with asthma on regular treatment with ICS or using short-acting inhaled 2-agonist as reliever to control asthma symptoms.\n* Age ≥ 5 \\< 12 years (8 to 10 children in the age range 5-8 years old).\n* Children with a forced expiratory volume in one second (FEV1)\\>70% of predicted values (% pred) after withholding 2-agonists treatment for a minimum of 4 h prior to screening and to each study treatment.\n* A cooperative attitude and ability to be trained about the proper use of DPI, ability to use correctly the medical devices and compliant to study procedures\n\nExclusion Criteria:\n\n* Past or present diagnosis of cardiovascular, renal or liver disease.\n* Known hypersensitivity to the active treatmen\n* Exacerbation of asthma symptoms within 4 weeks prior to screening.\n* Inability to perform the required breathing technique and blood sampling.\n* Hospitalization due to exacerbation of asthma within 1 month prior to screening (Visit 1).\n* Lower respiratory tract infection within 1 month prior to screening (Visit 1).\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': 'NCT02787967', 'briefTitle': 'Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'A Single-dose, Open-label, Randomized, 2-way Cross-over Study of CHF 1535 35/4 NEXThaler® (Fixed Combination of Beclometasone Dipropionate (BDP) 35 μg Plus Formoterol Fumarate (FF) 4 μg Versus the Free Combination of Licensed BDP DPI (Dry Powder Inhaler) and FF DPI in Asthmatic Children', 'orgStudyIdInfo': {'id': 'CCD-01535BB1-01'}, 'secondaryIdInfos': [{'id': '2015-005152-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NEXThaler® 35/4µg', 'description': 'CHF 1535 35/4µg NEXThaler® Dry Powder Inhaler, 4 inhalations. Total Dose: BDP 200µg FF 16µg', 'interventionNames': ['Drug: CHF 1535 35/4µg NEXThaler®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference treatment', 'description': 'Drug: free comb. beclomethasone DPI and formoterol DPI 2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg', 'interventionNames': ['Drug: free comb. beclomethasone DPI and formoterol DPI']}], 'interventions': [{'name': 'CHF 1535 35/4µg NEXThaler®', 'type': 'DRUG', 'description': '4 (four) inhalations (total dose: BDP/FF 140/16 µg)', 'armGroupLabels': ['NEXThaler® 35/4µg']}, {'name': 'free comb. beclomethasone DPI and formoterol DPI', 'type': 'DRUG', 'description': '2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg', 'armGroupLabels': ['Reference treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'BørneAstmaKlinikken, Hans Knudsens Plads 1A,', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Hans Bisgaard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen Studies on Asthma in Childhood'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}