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

Stefan Zielen

Status: Unknown

Conditions: Allergy to House Dust Mite; Allergic Asthma

Treatments: Diagnostic Test: Nasal provocation test (NPT); Diagnostic Test: Methacholine test; Diagnostic Test: Peak nasal expiratory flow (PNIF); Diagnostic Test: Bronchial allergen provocation (BAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04109534

19-263

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

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

Treatment:

Diagnostic Test: Nasal provocation test (NPT)

Diagnostic Test: Peak nasal expiratory flow (PNIF)

Diagnostic Test: Methacholine test

Diagnostic Test: Bronchial allergen provocation (BAP)

Verum

Active Comparator group

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

Treatment:

Diagnostic Test: Nasal provocation test (NPT)

Diagnostic Test: Peak nasal expiratory flow (PNIF)

Diagnostic Test: Methacholine test

Diagnostic Test: Bronchial allergen provocation (BAP)