Clinical trial NCT04109534: Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Asthma
Allergy to House Dust Mite
Keywords: allergic asthma,
house dust mite allergy
bronchial allergen provocation
LCPUFAs
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo-controlled prospective study
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Decrase of exhaled NO (eNO) after BAP
timeFrame: 4 weeks
Secondary outcomes:
measure: Absolute levels eNO
timeFrame: 4 weeks
measure: Magnitude of EAR
timeFrame: 4 weeks
measure: Magnitude of LAR
timeFrame: 4 weeks
measure: FEV1 after BAP
timeFrame: 4 weeks
measure: Comparison of methacholin levels
timeFrame: 4 weeks
measure: Asthma control test (ACT)
timeFrame: 4 weeks
measure: Cumulative Salbutamol use
timeFrame: 4 days
measure: Lebel symptom score
timeFrame: 4 weeks
measure: Peak nasal expiratory flow
timeFrame: 4 weeks
measure: Visual analog scala (VAS)-score after NPT
timeFrame: 4 weeks
measure: Visual analog scala (VAS)-score for nasal symptoms
timeFrame: 5 days
Other outcomes:
measure: Levels of LCPUFA
timeFrame: 4 weeks
measure: Levels of triglyceride and cholesterin
timeFrame: 4 weeks
measure: Levels of eosinophils
timeFrame: 4 weeks
measure: micro RNAs
timeFrame: 4 weeks
Locations:
city: Frankfurt
country: Germany
facility: Klinik für Kinder- und Jugendmedizin Universitätsklinikum
state: Hessen
Study officials:
affiliation: Klinik für Kinder- und Jugendmedizin Universitätsklinikum
name: Stefan Zielen, Professor
role: PRINCIPAL_INVESTIGATOR
References: