Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT02635334
Status:
COMPLETED
Last Update Posted:
2016-10-05
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asthma in the Elderly: The Effect of Montelukast
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-05-10', 'releaseDate': '2018-04-10'}], 'estimatedResultsFirstSubmitDate': '2018-04-10'}}, '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': 'C093875', 'term': 'montelukast'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-04', 'studyFirstSubmitDate': '2015-12-10', 'studyFirstSubmitQcDate': '2015-12-15', 'lastUpdatePostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of montelukast on asthma symptoms assessed by daily symptom scores.', 'timeFrame': '8 weeks'}, {'measure': 'Effect of montelukast on the Asthma Control Test.', 'timeFrame': '8 weeks'}, {'measure': 'Effect of montelukast on number of puffs of albuterol used to relieve asthma symptoms.', 'timeFrame': '8 weeks'}, {'measure': 'Effect of montelukast on lung capacity assessed by spirometry (FEV1).', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Effect of montelukast on peripheral blood eosinophils counts.', 'timeFrame': '8 weeks'}, {'measure': 'Effect of montelukast on total serum IgE.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the treatment of asthma in subjects who are 12 month old and older. This study is being done because there has been no placebo controlled study of montelukast focused on this group of patients. Elderly asthmatics have been mostly ignored in asthma studies. They are more likely to be underdiagnosed, undertreated, and hospitalized for asthma when compared to younger asthmatics. The pathophysiology of asthma in the elderly is typically different than in younger patients. This is a double-blind, placebo-controlled, crossover study. Investigators plan to enroll thirty subjects who have been diagnosed with asthma for at least one year, are non smoker, and did not smoke for more than 10 pack/year of tobacco products in their lifetime. After a run-in period of one week, the study subjects will take montelukast 10 mg orally for 8 weeks first and then placebo for 8 weeks, or vice versa. Primary objectives of this study are to evaluate the effect of montelukast on asthma symptoms assessed by daily symptom scores, the Asthma Control Test and the number of puffs of albuterol, and spirometric values (FEV1). Secondary objectives include studying whether montelukast affects peripheral blood eosinophils counts and serum IgE levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asthma diagnosed for at least one year;\n* Able to swallow small capsules.\n\nExclusion Criteria:\n\n* Tobacco smoking for more than 10/pack years;\n* Previous adverse reaction to montelukast or other leukotriene inhibitor;\n* History of hypereosinophilic disorder other than atopic disease;\n* Treatment with montelukast within 4 weeks from randomization;\n* Asthma exacerbation or treatment with prednisone/other systemic steroid within 4 weeks from randomization.'}, 'identificationModule': {'nctId': 'NCT02635334', 'briefTitle': 'Asthma in the Elderly: The Effect of Montelukast', 'organization': {'class': 'OTHER', 'fullName': 'Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.'}, 'officialTitle': 'Asthma in the Elderly: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study of the Effect of Montelukast', 'orgStudyIdInfo': {'id': 'SSRF2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Montelukast 10 mg daily for 8 weeks', 'description': 'Study subjects will take montelukast 10 mg orally daily for 8 weeks', 'interventionNames': ['Drug: Montelukast 10 mg orally', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo daily for 8 weeks', 'description': 'Study subjects will take placebo orally daily for 8 weeks', 'interventionNames': ['Drug: Montelukast 10 mg orally', 'Other: Placebo']}], 'interventions': [{'name': 'Montelukast 10 mg orally', 'type': 'DRUG', 'otherNames': ['Singulair'], 'armGroupLabels': ['Montelukast 10 mg daily for 8 weeks', 'Placebo daily for 8 weeks']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Montelukast 10 mg daily for 8 weeks', 'Placebo daily for 8 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}], 'overallOfficials': [{'name': 'Michele Columbo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rohr and Columbo Asthma, Allergy, and Immunology Specialists'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michele Columbo, M.D.', 'investigatorAffiliation': 'Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-04-10', 'type': 'RELEASE'}, {'date': '2018-05-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Michele Columbo, M.D., Principal Investigator, Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.'}}}}