Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-04-25 @ 12:55 PM
Study NCT ID:
NCT02148120
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2014-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2014-05-21', 'studyFirstSubmitQcDate': '2014-05-23', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1 Area under the curve', 'timeFrame': 'until 12 h post dose', 'description': 'FEV1= Forced expiratory volume in the first second of expiration'}], 'secondaryOutcomes': [{'measure': 'FEV1 peak', 'timeFrame': 'until 12 h post dose', 'description': 'Maximum FEV1 value'}, {'measure': 'FVC area under the curve', 'timeFrame': 'until 12 h post dose', 'description': 'FVC = Forced Vital Capacity'}, {'measure': 'FVC peak', 'timeFrame': 'until 12 h post dose', 'description': 'Maximum FVC'}, {'measure': 'Adverse events', 'timeFrame': 'over a period of 5 to 14 weeks', 'description': 'from the signature of the informed consent until the end of the study, the total duration depends on the duration of the run-in and wash-out periods.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-004826-27', 'label': 'Study Record on EU Clinical Trials Register including results'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient\'s written informed consent obtained prior to any study-related procedures.\n* Male or female aged between 18 and 65 years inclusive;\n* Evidence for "partially controlled" or "uncontrolled" asthma;\n* Medium daily dose of previous inhaled corticosteroids (ICS) treatment;\n* FEV1 between 60% and 85% of the predicted normal values;\n* A documented positive response to the reversibility test;\n* Non-smokers or ex-smokers;\n* A cooperative attitude and ability to be trained in the proper use of a DPI.\n\nExclusion Criteria:\n\n* Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception.\n* Significant seasonal variation in asthma occurring or expected to occur during study participation;\n* History of near fatal asthma, brittle asthma, accident and Emergency treatment or hospitalisation for asthma exacerbation in Intensive Care Unit within 1 year before screening;\n* Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening;\n* Diagnosis of Chronic Obstructive Pulmonary Disease;\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 8 weeks;\n* Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids;\n* Allergy, sensitivity or intolerance to study drugs or excipients;\n* Patients who received any investigational drug within the last 8 weeks before the screening;\n* Patients taking any of the non-permitted concomitant medication;\n* Subjects unlikely to comply with the study protocol;\n* Any clinically relevant abnormal value or physical finding at screening;\n* Significant medical history;\n* Abnormal and clinically significant 12-lead electrocardiogram;\n* Patients with low compliance of QVAR intake.'}, 'identificationModule': {'nctId': 'NCT02148120', 'briefTitle': 'A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'A Phase II, Multicentre, Double-blind, Randomised, 5-way Crossover Study to Test the Non-inferiority of the Acute Bronchodilator Effect of CHF 1535 200/6 µg NEXThaler Versus CHF 1535 100/6 µg NEXThaler in Partially Controlled and Uncontrolled Adult Asthmatic Patients.', 'orgStudyIdInfo': {'id': 'CCD-01535BA1-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CHF1535 NEXThaler 100/6, 1 puff', 'description': 'Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg', 'interventionNames': ['Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHF1535 NEXThaler 100/6 µg, 4 puffs', 'description': 'Beclometasone Dipropionate 400 µg + Formoterol Fumarate 24 µg', 'interventionNames': ['Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg']}, {'type': 'EXPERIMENTAL', 'label': 'CHF1535 NEXThaler 200/6 µg, 1 puff', 'description': 'Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg', 'interventionNames': ['Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg']}, {'type': 'EXPERIMENTAL', 'label': 'CHF1535 NEXThaler 200/6 µg, 4 puffs', 'description': 'Beclometasone Dipropionate 800 µg + Formoterol Fumarate 24 µg', 'interventionNames': ['Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo NEXThaler', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg', 'type': 'DRUG', 'otherNames': ['Foster NEXThaler'], 'armGroupLabels': ['CHF1535 NEXThaler 100/6 µg, 4 puffs', 'CHF1535 NEXThaler 100/6, 1 puff']}, {'name': 'Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg', 'type': 'DRUG', 'armGroupLabels': ['CHF1535 NEXThaler 200/6 µg, 1 puff', 'CHF1535 NEXThaler 200/6 µg, 4 puffs']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo NEXThaler']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Medicines Research', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1G 8HU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Respiratory Clinical Trials, Hearth Lung Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M23 9QZ', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Medicines Evaluation Unit', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}