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Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma (LCPUFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04109534
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Stefan Zielen, Johann Wolfgang Goethe University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Allergic Asthma Allergy to House Dust Mite Diagnostic Test: Bronchial allergen provocation (BAP) Diagnostic Test: Nasal provocation test (NPT) Diagnostic Test: Methacholine test Diagnostic Test: Peak nasal expiratory flow (PNIF) Not Applicable

Detailed Description:

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.

In 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo-controlled prospective study
Masking: Double (Participant, Investigator)
Masking Description: LCPUVAS and Placebo are provided in sealed bags
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Asthma

Arm Intervention/treatment
Placebo Comparator: Placebo
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
Diagnostic Test: Bronchial allergen provocation (BAP)
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

Diagnostic Test: Nasal provocation test (NPT)
Dermatophagoides farina will be administered in both nostrils

Diagnostic Test: Methacholine test
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

Diagnostic Test: Peak nasal expiratory flow (PNIF)
Comparison of peak nasal expiratory flow (PNIF) after NPT between groups

Active Comparator: Verum
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
Diagnostic Test: Bronchial allergen provocation (BAP)
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

Diagnostic Test: Nasal provocation test (NPT)
Dermatophagoides farina will be administered in both nostrils

Diagnostic Test: Methacholine test
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

Diagnostic Test: Peak nasal expiratory flow (PNIF)
Comparison of peak nasal expiratory flow (PNIF) after NPT between groups




Primary Outcome Measures :
  1. Decrase of exhaled NO (eNO) after BAP [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Absolute levels eNO [ Time Frame: 4 weeks ]
    Comparison of absolute levels eNO (ppb)at end of treatment between groups

  2. Magnitude of EAR [ Time Frame: 4 weeks ]
    Comparison of EAR (maximum decrease of FEV1) at end of treatment between groups

  3. Magnitude of LAR [ Time Frame: 4 weeks ]
    Comparison of LAR (maximum decrease of FEV1 in %) at end of treatment between groups

  4. FEV1 after BAP [ Time Frame: 4 weeks ]
    Comparison of FEV1 Levels 24 hours after BAP between groups

  5. Comparison of methacholin levels [ Time Frame: 4 weeks ]
    Comparison of methacholin (mg) Levels 24 hours after BAP between groups

  6. Asthma control test (ACT) [ Time Frame: 4 weeks ]
    Comparison of ACT score between Groups at end of treatment

  7. Cumulative Salbutamol use [ Time Frame: 4 days ]
    Cumulative Salbutamol use in the last 4 days of treatment during repetitive BAP between groups

  8. Lebel symptom score [ Time Frame: 4 weeks ]
    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.

  9. Peak nasal expiratory flow [ Time Frame: 4 weeks ]
    Comparison of peak nasal expiratory flow (PNIF) after NPT between groups

  10. Visual analog scala (VAS)-score after NPT [ Time Frame: 4 weeks ]
    Comparison of VAS (mm) after NPT between groups

  11. Visual analog scala (VAS)-score for nasal symptoms [ Time Frame: 5 days ]
    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


Other Outcome Measures:
  1. Levels of LCPUFA [ Time Frame: 4 weeks ]
    Levels of LCPUFA will be measured before and after Supplementation between groups

  2. Levels of triglyceride and cholesterin [ Time Frame: 4 weeks ]
    Levels of triglyceride and cholesterin will be measured before and after supplementation between groups

  3. Levels of eosinophils [ Time Frame: 4 weeks ]
    Levels of eosinophils will be measured after supplementation and 24 hours after BAP between groups

  4. micro RNAs [ Time Frame: 4 weeks ]
    Levels of micro RNAs will be measured before supplementation and before and 24 hours after BAP between groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent

    • Patients: aged ≥18 and 45 years
    • known allergen induced asthma and HDM-Allergy
    • basic lung function FVC ≥ 80%, FEV1 ≥ 75%
    • decrease in FEV1 after BAP ≥ 20%
    • 30% increase of NO after BAP

Exclusion Criteria:

  • lung function Forced vital capacity (FVC) <80% and Forced expiratory volume in 1 second (FEV1) <75%
  • chronic diseases or infections (e.g. HIV, Tbc)
  • pregnancy
  • systemic corticosteroid-treatment
  • inhalative corticosteroid therapy or leukotriene antagonists
  • alcohol, substance or drug abuse
  • current smokers
  • inability to capture extend and consequences of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109534


Contacts
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Contact: Stefan Zielen, Professor +496301 ext 83349 Stefan.Zielen@kgu.de
Contact: Susanne Middelkamp +496301 ext 83349 Susanne.Middelkamp@kgu.de

Locations
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Germany
Klinik für Kinder- und Jugendmedizin Universitätsklinikum Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Stefan Zielen, Professor    +49 696301 ext 83063    Stefan.zielen@kgu.de   
Contact: Paola JE Gnago, MD    +4915780560152    Paola.Gnago@kgu.de   
Sponsors and Collaborators
Stefan Zielen
Investigators
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Principal Investigator: Stefan Zielen, Professor Klinik für Kinder- und Jugendmedizin Universitätsklinikum

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Responsible Party: Stefan Zielen, Professor, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT04109534    
Other Study ID Numbers: 19-263
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized data will be provided of the investigated cohort
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After end of study anticipated June 2020
Access Criteria: The data will be available after the end of study and successful publication of the results (anticipated June 2021 for 10 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefan Zielen, Johann Wolfgang Goethe University Hospital:
allergic asthma,
house dust mite allergy
bronchial allergen provocation
LCPUFAs
Additional relevant MeSH terms:
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Asthma
Hypersensitivity
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pathologic Processes
Methacholine Chloride
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action