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

Allergic Asthma Clinical Trial

— LCPUFA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109534
• Other study ID #: 19-263
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2019
• Source: Johann Wolfgang Goethe University Hospital
• Contact: Stefan Zielen, Professor
• Phone: +496301
• Email: Stefan.Zielen[@]kgu.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma
• Allergy to House Dust Mite
• Asthma
• Hypersensitivity
• Inflammation

Intervention

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
• Nasal provocation test (NPT)
Dermatophagoides farina will be administered in both nostrils
• 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
• Peak nasal expiratory flow (PNIF)
Comparison of peak nasal expiratory flow (PNIF) after NPT between groups

Locations

Country	Name	City	State
Germany	Klinik für Kinder- und Jugendmedizin Universitätsklinikum	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Stefan Zielen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Levels of LCPUFA	Levels of LCPUFA will be measured before and after Supplementation between groups	4 weeks
Other	Levels of triglyceride and cholesterin	Levels of triglyceride and cholesterin will be measured before and after supplementation between groups	4 weeks
Other	Levels of eosinophils	Levels of eosinophils will be measured after supplementation and 24 hours after BAP between groups	4 weeks
Other	micro RNAs	Levels of micro RNAs will be measured before supplementation and before and 24 hours after BAP between groups	4 weeks
Primary	Decrase of exhaled NO (eNO) after BAP	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.	4 weeks
Secondary	Absolute levels eNO	Comparison of absolute levels eNO (ppb)at end of treatment between groups	4 weeks
Secondary	Magnitude of EAR	Comparison of EAR (maximum decrease of FEV1) at end of treatment between groups	4 weeks
Secondary	Magnitude of LAR	Comparison of LAR (maximum decrease of FEV1 in %) at end of treatment between groups	4 weeks
Secondary	FEV1 after BAP	Comparison of FEV1 Levels 24 hours after BAP between groups	4 weeks
Secondary	Comparison of methacholin levels	Comparison of methacholin (mg) Levels 24 hours after BAP between groups	4 weeks
Secondary	Asthma control test (ACT)	Comparison of ACT score between Groups at end of treatment	4 weeks
Secondary	Cumulative Salbutamol use	Cumulative Salbutamol use in the last 4 days of treatment during repetitive BAP between groups	4 days
Secondary	Lebel symptom score	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.	4 weeks
Secondary	Peak nasal expiratory flow	Comparison of peak nasal expiratory flow (PNIF) after NPT between groups	4 weeks
Secondary	Visual analog scala (VAS)-score after NPT	Comparison of VAS (mm) after NPT between groups	4 weeks
Secondary	Visual analog scala (VAS)-score for nasal symptoms	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	5 days