Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-06 @ 6:35 AM
Study NCT ID:
NCT02049294
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2014-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069444', 'term': 'Omalizumab'}, {'id': 'C026408', 'term': 'anti-IgE antibodies'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2014-01-29', 'lastUpdatePostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '• Sputum eosinophilopoietic cytokines, chemokines, immunoglobulin levels, expression variation of constitutive immunoglobulin receptors.', 'timeFrame': 'From Week 0 to Week 12 and Week 12 to week 32'}, {'measure': 'IgE antagonism and its effect on TSLP with respect to in situ eosinophilopoeisis and local eosinophil activity', 'timeFrame': 'From Week 0 to Week 12 and Week 12 to week 32'}], 'primaryOutcomes': [{'measure': 'Proportion of patients with change in absolute % count of sputum eosinophil week 0 to week 12, and week 12 to week 32', 'timeFrame': 'From Week 0 to Week 12 and Week 12 to week 32'}, {'measure': 'Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32.', 'timeFrame': 'From Week 12 to Week 32'}], 'secondaryOutcomes': [{'measure': 'change in % sputum eosinophil', 'timeFrame': 'From Week 0 to Week 32'}, {'measure': 'Blood eosinophils', 'timeFrame': 'From Week 0 to week 32'}, {'measure': 'Forced Expired Volume in 1 second (FEV1)', 'timeFrame': 'From Week 0 to Week 32'}, {'measure': 'Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC)', 'timeFrame': 'From Week 0 to Week 32'}, {'measure': 'Provocative concentration causing a 20% drop in FEV1 (PC20)', 'timeFrame': 'From Week 0 to Week 32'}, {'measure': 'Asthma Control Questionnaire', 'timeFrame': 'From Week 0 to Week 32'}, {'measure': 'Fraction of exhaled nitric oxide (FeNO)', 'timeFrame': 'From Week 0 to Week 32'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prednisone', 'Eosinophils', 'Immunoglobin E (IgE)', 'Asthma', 'Bronchitis', 'Inflammation', 'Allergy'], 'conditions': ['Steroid and/or Prednisone Dependent Asthma', 'Eosinophilic Bronchitis']}, 'referencesModule': {'references': [{'pmid': '30988677', 'type': 'DERIVED', 'citation': 'Mukherjee M, Kjarsgaard M, Radford K, Huang C, Leigh R, Dorscheid DR, Lemiere C, Boulet LP, Waserman S, Martin J, Nair P. Omalizumab in patients with severe asthma and persistent sputum eosinophilia. Allergy Asthma Clin Immunol. 2019 Apr 3;15:21. doi: 10.1186/s13223-019-0337-2. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether addition of Omalizumab enables a reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.\n\nThis will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial divided into two sequential study periods.\n\nPeriod 1: After establishing the minimum dose of prednisone to maintain asthma control and maintain sputum eosinophils \\<3%, subjects will be randomized to either placebo or Omalizumab for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).\n\nPeriod 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab or placebo during the entire duration of the study but not continue the phase of steroid reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n1. Confirmed asthma within the past 2 years (12% bronchodilator reversibility or PC20 methacholine less than 8 mg/ml)\n2. ACQ ≥1.5 and sputum eos ≥3% at the time of randomization\n3. On ICS (≥ 1500 mcg fluticasone propionate or equivalent) with or without additional prednisone\n4. Total serum IgE ≥30 IU/L and positive allergy skin prick test\n5. Age between 18 and 75 years\n6. Ability to provide informed consent\n\nExclusion criteria\n\n1. Current smoker or ex-smokers with greater than 20 pack years\n2. Co-morbid diseases which in the investigator's opinion would make the patient unsuitable to participate in the study\n3. Currently on Omalizumab or has previously been treated with Omalizumab\n4. Currently on other biologic therapies (eg. Prolia)\n5. Pregnancy or lactation\n6. Post bronchodilator FEV1 less than 50% predicted"}, 'identificationModule': {'nctId': 'NCT02049294', 'briefTitle': 'Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Randomized Double Blind Placebo Controlled Trial of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis', 'orgStudyIdInfo': {'id': 'RP 14-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omalizumab (Xolair)', 'description': 'Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level.', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Normal Saline)', 'description': '0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab', 'interventionNames': ['Biological: Omalizumab (Xolair)']}], 'interventions': [{'name': 'Omalizumab (Xolair)', 'type': 'BIOLOGICAL', 'otherNames': ['Anti IgE'], 'armGroupLabels': ['Placebo (Normal Saline)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['0.9% normal saline'], 'armGroupLabels': ['Omalizumab (Xolair)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Richard Leigh', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'University of Laval', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'University of Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Parameswaran Nair, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}, {'name': 'Louis-Philippe Boulet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Laval'}, {'name': 'Catherine Lemiere, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal'}, {'name': 'Richard Leigh, MB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Delbert Dorscheid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}