Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-28 @ 5:32 AM
Study NCT ID:
NCT04109534
Status:
UNKNOWN
Last Update Posted:
2019-10-01
First Post:
2019-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092542', 'term': 'Dust Mite Allergy'}], 'ancestors': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001985', 'term': 'Bronchial Provocation Tests'}, {'id': 'D009299', 'term': 'Nasal Provocation Tests'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'LCPUVAS and Placebo are provided in sealed bags'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo-controlled prospective study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-29', 'studyFirstSubmitDate': '2019-09-27', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Levels of LCPUFA', 'timeFrame': '4 weeks', 'description': 'Levels of LCPUFA will be measured before and after Supplementation between groups'}, {'measure': 'Levels of triglyceride and cholesterin', 'timeFrame': '4 weeks', 'description': 'Levels of triglyceride and cholesterin will be measured before and after supplementation between groups'}, {'measure': 'Levels of eosinophils', 'timeFrame': '4 weeks', 'description': 'Levels of eosinophils will be measured after supplementation and 24 hours after BAP between groups'}, {'measure': 'micro RNAs', 'timeFrame': '4 weeks', 'description': 'Levels of micro RNAs will be measured before supplementation and before and 24 hours after BAP between groups'}], 'primaryOutcomes': [{'measure': 'Decrase of exhaled NO (eNO) after BAP', 'timeFrame': '4 weeks', 'description': 'After BAP with HDM the decrease of eNO will be compared between placebo and active comparator. A relevant decrease is defined as a drop of 30% of exhaled NO.'}], 'secondaryOutcomes': [{'measure': 'Absolute levels eNO', 'timeFrame': '4 weeks', 'description': 'Comparison of absolute levels eNO (ppb)at end of treatment between groups'}, {'measure': 'Magnitude of EAR', 'timeFrame': '4 weeks', 'description': 'Comparison of EAR (maximum decrease of FEV1) at end of treatment between groups'}, {'measure': 'Magnitude of LAR', 'timeFrame': '4 weeks', 'description': 'Comparison of LAR (maximum decrease of FEV1 in %) at end of treatment between groups'}, {'measure': 'FEV1 after BAP', 'timeFrame': '4 weeks', 'description': 'Comparison of FEV1 Levels 24 hours after BAP between groups'}, {'measure': 'Comparison of methacholin levels', 'timeFrame': '4 weeks', 'description': 'Comparison of methacholin (mg) Levels 24 hours after BAP between groups'}, {'measure': 'Asthma control test (ACT)', 'timeFrame': '4 weeks', 'description': 'Comparison of ACT score between Groups at end of treatment'}, {'measure': 'Cumulative Salbutamol use', 'timeFrame': '4 days', 'description': 'Cumulative Salbutamol use in the last 4 days of treatment during repetitive BAP between groups'}, {'measure': 'Lebel symptom score', 'timeFrame': '4 weeks', 'description': 'Comparison of Lebel symptom score after nasal provocation test (NPT), before and after supplementation between groups. A lebel score of 0-4 is negative, a lebel score \\>5 positive, the maximum result is 12.'}, {'measure': 'Peak nasal expiratory flow', 'timeFrame': '4 weeks', 'description': 'Comparison of peak nasal expiratory flow (PNIF) after NPT between groups'}, {'measure': 'Visual analog scala (VAS)-score after NPT', 'timeFrame': '4 weeks', 'description': 'Comparison of VAS (mm) after NPT between groups'}, {'measure': 'Visual analog scala (VAS)-score for nasal symptoms', 'timeFrame': '5 days', 'description': 'Comparison of cumulative VAS-score for 4 nasal symptoms (Total mm each symptom) in the last 5 days of treatment during repetitive BAP between groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allergic asthma,', 'house dust mite allergy', 'bronchial allergen provocation', 'LCPUFAs'], 'conditions': ['Allergic Asthma', 'Allergy to House Dust Mite']}, 'descriptionModule': {'briefSummary': 'The proposed study will investigate the effect of a polyunsaturated fatty acid / lipid mixture (LCPUFAs) on the clinical symptoms, bronchial inflammation and lung function in allergic asthma in a bronchial allergen provocation (BAP) model. For this purpose, patients with stable episodic asthma and dust mite allergy will underwent BAP before and after supplementation with LCPUFAs. The clinical symptoms, bronchial inflammation, exhaled NO increase and lung function decline (FEV1) will be analyzed.', 'detailedDescription': 'Asthma is a chronic lung disease, which is characterized by recurrent obstruction, a hypersensitivity and a chronic inflammation of the airway. It is known that LCPUVAs could reduce the production of inflammatory mediators. In addition, LCPUVAs can improve pulmonary function, with a concurrent reduction in bronchodilator use in patients with asthma. Subjects suffering from episodic asthma and house dust mite (HDM) allergy usually have a normal lung function testing at rest and show a decrease in lung function when they are exposed to HDM. Bronchial allergen provocation models are well established in asthma research and allow the evaluation of anti-allergic and anti-asthmatic agents in relatively small sample sizes. In a previous study the investigators could show, that LCPUVAs could reduce exhaled NO after repeated BAP with HDM.\n\nIn this study the investigators will investigate the protective effect of LCPUVAs in a repeated BAP model. Clinical symptoms (nasal and bronchial), exhaled NO, decrease in lung function the early asthmatic reaction (EAR), the late asthmatic reaction (LAR) and blood parameters (Triglyceride and Cholesterin and mircro RNAs) will be measured before and after LCPUVA supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n\n * Patients: aged ≥18 and 45 years\n * known allergen induced asthma and HDM-Allergy\n * basic lung function FVC ≥ 80%, FEV1 ≥ 75%\n * decrease in FEV1 after BAP ≥ 20%\n * 30% increase of NO after BAP\n\nExclusion Criteria:\n\n* lung function Forced vital capacity (FVC) \\<80% and Forced expiratory volume in 1 second (FEV1) \\<75%\n* chronic diseases or infections (e.g. HIV, Tbc)\n* pregnancy\n* systemic corticosteroid-treatment\n* inhalative corticosteroid therapy or leukotriene antagonists\n* alcohol, substance or drug abuse\n* current smokers\n* inability to capture extend and consequences of the study'}, 'identificationModule': {'nctId': 'NCT04109534', 'acronym': 'LCPUFA', 'briefTitle': 'Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Investigation of the Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma and House Dust Mite Allergy After Repeated Allergen Challenge', 'orgStudyIdInfo': {'id': '19-263'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo comparator 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Placebo Comparator', 'interventionNames': ['Diagnostic Test: Bronchial allergen provocation (BAP)', 'Diagnostic Test: Nasal provocation test (NPT)', 'Diagnostic Test: Methacholine test', 'Diagnostic Test: Peak nasal expiratory flow (PNIF)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Verum', 'description': 'PUFAS: 2640 mg of middle-chain and polyunsaturated fatty acids 20 patients aged 18-45 years with a diagnosis of HDM induced allergic asthma and an increase of exhaled NO of 30% after BAP will be randomized to the Active Comparator', 'interventionNames': ['Diagnostic Test: Bronchial allergen provocation (BAP)', 'Diagnostic Test: Nasal provocation test (NPT)', 'Diagnostic Test: Methacholine test', 'Diagnostic Test: Peak nasal expiratory flow (PNIF)']}], 'interventions': [{'name': 'Bronchial allergen provocation (BAP)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Nebulized Dermatophagoides farina administered at following doses: 10AE, 20 AE, 40 AE, 80 160 AE, etc… until the FEV1 decreases 20% below the initial FEV1-value', 'armGroupLabels': ['Placebo', 'Verum']}, {'name': 'Nasal provocation test (NPT)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Dermatophagoides farina will be administered in both nostrils', 'armGroupLabels': ['Placebo', 'Verum']}, {'name': 'Methacholine test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Nebulized metacholine will be administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg until the FEV1 decreases 20% below the initial FEV1-value', 'armGroupLabels': ['Placebo', 'Verum']}, {'name': 'Peak nasal expiratory flow (PNIF)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Comparison of peak nasal expiratory flow (PNIF) after NPT between groups', 'armGroupLabels': ['Placebo', 'Verum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Zielen, Professor', 'role': 'CONTACT', 'email': 'Stefan.zielen@kgu.de', 'phone': '+49 696301', 'phoneExt': '83063'}, {'name': 'Paola JE Gnago, MD', 'role': 'CONTACT', 'email': 'Paola.Gnago@kgu.de', 'phone': '+4915780560152'}], 'facility': 'Klinik für Kinder- und Jugendmedizin Universitätsklinikum', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'centralContacts': [{'name': 'Stefan Zielen, Professor', 'role': 'CONTACT', 'email': 'Stefan.Zielen@kgu.de', 'phone': '+496301', 'phoneExt': '83349'}, {'name': 'Susanne Middelkamp', 'role': 'CONTACT', 'email': 'Susanne.Middelkamp@kgu.de', 'phone': '+496301', 'phoneExt': '83349'}], 'overallOfficials': [{'name': 'Stefan Zielen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Kinder- und Jugendmedizin Universitätsklinikum'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After end of study anticipated June 2020', 'ipdSharing': 'YES', 'description': 'Anonymized data will be provided of the investigated cohort', 'accessCriteria': 'The data will be available after the end of study and successful publication of the results (anticipated June 2021 for 10 years'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stefan Zielen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stefan Zielen', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}