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

NCT04109534 | Unknown

• 1 other identifier: 19-263
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Asthma; Allergy to House Dust Mite

Keywords

allergic asthma,; house dust mite allergy; bronchial allergen provocation; LCPUFAs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Absolute levels eNO

  4 weeks

• Magnitude of EAR

  4 weeks

• Magnitude of LAR

  4 weeks

• FEV1 after BAP

  4 weeks

• Comparison of methacholin levels

  4 weeks

Other Outcomes (4)

• Levels of LCPUFA

  4 weeks

• Levels of triglyceride and cholesterin

  4 weeks

• Levels of eosinophils

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

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

Verum

ACTIVE COMPARATOR

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

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

Interventions

Bronchial allergen provocation (BAP) DIAGNOSTIC_TEST

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

Placebo; Verum

Nasal provocation test (NPT) DIAGNOSTIC_TEST

Dermatophagoides farina will be administered in both nostrils

Placebo; Verum

Methacholine test DIAGNOSTIC_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

Placebo; Verum

Peak nasal expiratory flow (PNIF) DIAGNOSTIC_TEST

Comparison of peak nasal expiratory flow (PNIF) after NPT between groups

Placebo; Verum

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%
• % increase of NO after BAP

You may not qualify if:

• 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

Sponsors & Collaborators

• Stefan Zielen: lead

Study Sites (1)

Klinik für Kinder- und Jugendmedizin Universitätsklinikum

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

MeSH Terms

Conditions

Dust Mite Allergy

Interventions

Bronchial Provocation Tests; Nasal Provocation Tests

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stefan Zielen, Professor

  Klinik für Kinder- und Jugendmedizin Universitätsklinikum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Zielen, Professor

CONTACT

+496301; Stefan.Zielen@kgu.de

Susanne Middelkamp

CONTACT

+496301; Susanne.Middelkamp@kgu.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: LCPUVAS and Placebo are provided in sealed bags
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Placebo-controlled prospective study

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: September 30, 2019
• Study Start: October 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After end of study anticipated June 2020
• Access Criteria: The data will be available after the end of study and successful publication of the results (anticipated June 2021 for 10 years

Locations

DE (1)