Total IgE (Immunoglobulin E) and Der p 1 (d1) Specific IgE in Induced Sputum in Patients With Allergic and Non-allergic Asthma

Asthma is a heterogeneous disease, and specifically the phenotype of non-allergic asthma is not yet well defined. Several studies describe this group of patients as having severe asthma, persistent eosinophilia and poor therapeutic response. Among the theories being considered is the role of local IgE. Objectives: 1) To perform a pilot test to validate the measurement technique and standardize the levels of total IgE and IgE specific to Dermatophagoides pteronyssinus (d1) in the induced sputum of asthmatic patients and healthy volunteers. 2) Correlate local total IgE and specific IgE levels to d1 (sputum and peripheral blood) in patients with allergic and non-allergic asthma. 3) Describe the clinical and inflammatory characteristics of patients with allergic and non-allergic asthma.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.

Barcelona, 08041, Spain

About this study

Comparative cross-sectional study. It will include 32 allergic and non-allergic asthma patients and 10 healthy volunteers. All patients will have an induced sputum, pulmonary function studies, FENO (exhaled fraction of nitric oxide), total and specific IgE measurement at d1 (the most common perennial pneumoallergen) in blood and induced sputum, as well as a prick skin test with standardized allergen extracts. Measurement of total IgE and IgE for d1 in induced sputum will be performed in the supernatant and by the ImmunoCAP (Phadia ThermoFisher Scientific) immunofluoroassay technique.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18-70
Asthma according to GEMA (spanish asthma guideline)

Exclusion criteria

Pregnancy
Active smoking
Moderate alcohol consumption
Atopic dermatitis
Other respiratory disease different than asthma (COPD, bronchiectasis, cystic fibrosis, pleural disease, interstitial disease)
Treatment with steroids or inmunodepressants
Active malignancy.

Treatment and study plan

Induced Sputum

Behavioral

Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum

Primary outcomes

Levels of specific IgE

Time frame: 8 months

Detection of high levels or not of specific IgE in induced sputum

Secondary outcomes

Levels of total IgE

Time frame: 8 months

Detection of high levels or not of total IgE in induced sputum

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Registry information

Official study title

Total IgE and Der p 1 (d1) Specific IgE in Induced Sputum in Patients With Allergic and Non-allergic Asthma

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2019
First posted: Aug 21, 2018
Registry last updated: Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed