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

NCT04109534 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-01

No results posted yet for this study

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.

Conditions

  • Allergic Asthma
  • Allergy to House Dust Mite

Interventions

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

Sponsors & Collaborators

  • Stefan Zielen

    lead OTHER

Principal Investigators

  • Stefan Zielen, Professor · Klinik für Kinder- und Jugendmedizin Universitätsklinikum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-06-30
Completion
2020-12-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04109534 on ClinicalTrials.gov