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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04109534
Other study ID # 19-263
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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