Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-02 @ 2:28 AM
Study NCT ID:
NCT00676468
Status:
COMPLETED
Last Update Posted:
2009-10-09
First Post:
2008-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}, {'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-08', 'studyFirstSubmitDate': '2008-05-09', 'studyFirstSubmitQcDate': '2008-05-12', 'lastUpdatePostDateStruct': {'date': '2009-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary function', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Exhaled breathe condensate markers to measure airway inflammation', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Inflammation', 'Airway', 'Fish Oil', 'Singulair'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '12904324', 'type': 'BACKGROUND', 'citation': 'Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6.'}, {'pmid': '16424411', 'type': 'BACKGROUND', 'citation': 'Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest. 2006 Jan;129(1):39-49. doi: 10.1378/chest.129.1.39.'}, {'pmid': '20976161', 'type': 'DERIVED', 'citation': 'Tecklenburg-Lund S, Mickleborough TD, Turner LA, Fly AD, Stager JM, Montgomery GS. Randomized controlled trial of fish oil and montelukast and their combination on airway inflammation and hyperpnea-induced bronchoconstriction. PLoS One. 2010 Oct 18;5(10):e13487. doi: 10.1371/journal.pone.0013487.'}]}, 'descriptionModule': {'briefSummary': 'Combining fish oil supplementation and Montelukast \\[a commonly used cyst LT1 receptor antagonist to treat exercise-induced bronchoconstriction (EIB)\\] will provide a greater antiinflammatory effect against developing EIB that either agent alone', 'detailedDescription': 'The aim of this study is to extend previous published findings that fish oil supplementation represents a beneficial treatment on exercise-induced bronchoconstriction (EIB). An important question is how dietary fish oil supplementation fits in with the available armamentarium \\[e.g., leukotriene (LT) modifiers\\] to decrease the expression of LTs, and whether fish oil supplementation may be additive, or used in its own right to block the EIB response. For example, it is possible that a combination of fish oil supplementation and a cyst LT1 receptor antagonist (LTRA) may provide a greater antiinflammatory effect against developing EIB that either agent alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Demonstrate a fall in post-exercise FEV1 of \\> 10% after dry air exercise challenge for the diagnosis of EIB and\n* \\> 12% increase in FEV1 from the baseline value after the administration of a β2-agonist. However, if the bronchodilator response is \\< 12% increase in FEV1 from the baseline value then asthmatic subjects with EIB must further demonstrate\n* A \\< 16.0 mg.ml-1 concentration of methacholine causing a 20% decrease in FEV1 (PC20)\n\nExclusion Criteria:\n\n* Subjects will be excluded if they are pregnant\n* Have a history of hyperlipidemia, hypertension, diabetes, bleeding disorders, delayed clotting time\n* Taking aspirin medication and have a resting FEV1 less than 65% predicted.\n* A complete blood count and urinary pregnancy tests will be conducted at the beginning of the study and subjects with a hematocrit \\< 35 will be excluded from participation in the study.\n* In addition, subjects will also be excluded if they have a history of taking n-3 PUFA supplements or supplements with antioxidants above the levels recommended for Adequate Intake, or regularly consume more than one fish meal per week.'}, 'identificationModule': {'nctId': 'NCT00676468', 'briefTitle': 'Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Comparative Effects of Fish Oil Supplementation and a Leukotriene Receptor Antagonist on EIB and Airway Inflammation in Asthma', 'orgStudyIdInfo': {'id': '07-11765'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Active Montelukast + Fish Oil Placebo', 'interventionNames': ['Other: Active Montelukast + Fish Oil Placebo']}, {'type': 'OTHER', 'label': '2', 'description': 'Active Fish Oil + Montelukast Placebo', 'interventionNames': ['Other: Active Fish Oil + Montelukast Placebo']}, {'type': 'OTHER', 'label': '3', 'description': 'Active Montelukast + Active Fish Oil', 'interventionNames': ['Other: Active Montelukast + Active Fish Oil']}], 'interventions': [{'name': 'Active Montelukast + Fish Oil Placebo', 'type': 'OTHER', 'otherNames': ['Singulair (montelukast). Placebo (no brand name).'], 'description': 'Montelukast (1 x 10 mg tablet) per day + 10 tablets of fish oil placebo (soy bean oil) per day for a duration of 3 weeks', 'armGroupLabels': ['1']}, {'name': 'Active Fish Oil + Montelukast Placebo', 'type': 'OTHER', 'otherNames': ['Pro-Omega Fish Oil. Montelukast placebo (no brand name).'], 'description': '10 tablets (3.2 g EPA + 2.0 g DHA) per day and 1 x 10 mg Montelukast Placebo tablet per day for a duration of 3 weeks.', 'armGroupLabels': ['2']}, {'name': 'Active Montelukast + Active Fish Oil', 'type': 'OTHER', 'otherNames': ['Singulair (Montelukast) and Pro-Omega (Fish Oil).'], 'description': '1 x 10 mg Montelukast tablet per day and 10 tablets of active fish oil (3.2 g EPA + 2.0 g DHA) for a duration of 3 weeks.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}], 'overallOfficials': [{'name': 'Timothy D Mickleborough, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Timothy D Mickleborough / Associate Professor', 'oldOrganization': 'Indiana University'}}}}