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

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Completed
CT.gov ID
NCT03640936
Collaborator
(none)
32
1
48
0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Induced Sputum

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
32 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Total IgE and Der p 1 (d1) Specific IgE in Induced Sputum in Patients With Allergic and Non-allergic Asthma
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Healthy

Healthy controls, without asthma or allergy (negative prick test)

Behavioral: Induced Sputum
Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum

Allergic asthma

Patients with allergic asthma sensitized to Dermatophagoides pteronyssinus, tested by prick test or specific IgE

Behavioral: Induced Sputum
Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum

Non-allergic asthma

Patients with asthma not sensitized to Dermatophagoides pteronyssinus, with negative prick test or specific IgE

Behavioral: Induced Sputum
Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum

Outcome Measures

Primary Outcome Measures

  1. Levels of specific IgE [8 months]

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

Secondary Outcome Measures

  1. Levels of total IgE [8 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90. Barcelona Spain 08041

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT03640936
Other Study ID Numbers:
  • IIBSP-ASM-2014-66
First Posted:
Aug 21, 2018
Last Update Posted:
Jul 12, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2019