Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-20 @ 12:41 PM
Study NCT ID:
NCT03108534
Status:
COMPLETED
Last Update Posted:
2018-10-04
First Post:
2017-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-02', 'studyFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in FEV1 5-min post-dose', 'timeFrame': '5 min post-dose', 'description': 'Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)'}], 'secondaryOutcomes': [{'measure': 'Change in FEV1 other time points', 'timeFrame': 'Up to 30 min post-dose', 'description': 'Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)'}, {'measure': 'FEV1 AUC0-10min', 'timeFrame': 'From dosing to 10 min post-dose', 'description': 'FEV1 area under the curve from dosing to 10 min post-dose'}, {'measure': 'Time to recovery in FEV1', 'timeFrame': 'From dosing to 30 min post-dose', 'description': 'Time to return to 85% of baseline value'}, {'measure': 'Change in Borg scale', 'timeFrame': 'Up to 30 min post-dose', 'description': 'Change in Borg scale from the end of the methacholine challenge test'}, {'measure': 'Time to recovery in Borg scale', 'timeFrame': 'Up to 30 min post-dose', 'description': '50% decrease from the post-methacholine challenge value'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-003672-47/results', 'label': 'Study Record on EU Clinical Trials Register including results'}]}, 'descriptionModule': {'briefSummary': 'The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent form obtained\n* Minimum required Peak Inspiratory Flow (PIF) to activate NEXThaler\n* Pre-bronchodilator FEV1 of at least 65%\n* Positive response to methacholine challenge test\n* Previous treatment with low-medium doses of Inhaled Corticosteroids (ICS) or ICS/Long-acting beta2-agonist (LABA) as per Global Initiative for Asthma (GINA) 2016 guidelines\n* For females: non-pregnant, non-lactacting and using highly effective contraceptive methods.\n\nExclusion Criteria:\n\n* Clinically relevant and uncontrolled concomitant diseases\n* Abnormal clinically relevant ECG\n* Presence of aortic aneurism\n* Uncontrolled hypertension\n* Intake of non-permitted concomitant medications\n* Participation in another clinical trials in the previous 8 weeks\n* Seasonal variation in asthma\n* Recent occurrence of asthma exacerbations\n* Hypersensitivity to any product used in the trial, including excipients\n* Heavy caffeine drinkers\n* History of alcohol/drug abuse\n* Smokers'}, 'identificationModule': {'nctId': 'NCT03108534', 'briefTitle': 'A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'A Single Dose, Randomised, Double Blind, Double Dummy, Placebo Controlled, 3-way Crossover Clinical Study, Comparing the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 100/6 µg NEXThaler® Versus CHF1535 100/6 µg pMDI in Asthmatic Patients.', 'orgStudyIdInfo': {'id': 'CCD-01535BD1-01'}, 'secondaryIdInfos': [{'id': '2016-003672-47', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHF1535 NEXThaler', 'description': 'CHF1535 100/6 NEXThaler (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)', 'interventionNames': ['Drug: CHF1535 NEXThaler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHF1535 pMDI', 'description': 'CHF1535 100/6 pMDI (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)', 'interventionNames': ['Drug: CHF1535 pMDI']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Double dummy study: placebo is for both CHF1535 pMDI and CHF1535 NEXThaler', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CHF1535 NEXThaler', 'type': 'DRUG', 'otherNames': ['Foster NEXThaler'], 'description': 'Rescue treatment', 'armGroupLabels': ['CHF1535 NEXThaler']}, {'name': 'CHF1535 pMDI', 'type': 'DRUG', 'otherNames': ['Foster'], 'description': 'Rescue treatment', 'armGroupLabels': ['CHF1535 pMDI']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Rescue treatment', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'University of Dundee', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Medicines Research', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Medicines Evaluation Unit', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}