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

NCT ID: NCT03640936

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy

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

Induced Sputum

Intervention Type BEHAVIORAL

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

Induced Sputum

Intervention Type BEHAVIORAL

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

Induced Sputum

Intervention Type BEHAVIORAL

Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum

Interventions

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Induced Sputum

Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Johansson SG, Bieber T, Dahl R, Friedmann PS, Lanier BQ, Lockey RF, Motala C, Ortega Martell JA, Platts-Mills TA, Ring J, Thien F, Van Cauwenberge P, Williams HC. Revised nomenclature for allergy for global use: Report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. J Allergy Clin Immunol. 2004 May;113(5):832-6. doi: 10.1016/j.jaci.2003.12.591.

Reference Type BACKGROUND
PMID: 15131563 (View on PubMed)

Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012 May 4;18(5):716-25. doi: 10.1038/nm.2678.

Reference Type BACKGROUND
PMID: 22561835 (View on PubMed)

Crespo A, Giner J, Torrejon M, Belda A, Mateus E, Granel C, Torrego A, Ramos-Barbon D, Plaza V. Clinical and inflammatory features of asthma with dissociation between fractional exhaled nitric oxide and eosinophils in induced sputum. J Asthma. 2016 Jun;53(5):459-64. doi: 10.3109/02770903.2015.1116086. Epub 2016 Jan 19.

Reference Type BACKGROUND
PMID: 26785727 (View on PubMed)

Rondon C, Campo P, Zambonino MA, Blanca-Lopez N, Torres MJ, Melendez L, Herrera R, Gueant-Rodriguez RM, Gueant JL, Canto G, Blanca M. Follow-up study in local allergic rhinitis shows a consistent entity not evolving to systemic allergic rhinitis. J Allergy Clin Immunol. 2014 Apr;133(4):1026-31. doi: 10.1016/j.jaci.2013.10.034. Epub 2013 Dec 13.

Reference Type BACKGROUND
PMID: 24332860 (View on PubMed)

Baba S, Kondo K, Toma-Hirano M, Kanaya K, Suzukawa K, Ushio M, Suzukawa M, Ohta K, Yamasoba T. Local increase in IgE and class switch recombination to IgE in nasal polyps in chronic rhinosinusitis. Clin Exp Allergy. 2014;44(5):701-12. doi: 10.1111/cea.12287.

Reference Type BACKGROUND
PMID: 24931597 (View on PubMed)

Pin I, Gibson PG, Kolendowicz R, Girgis-Gabardo A, Denburg JA, Hargreave FE, Dolovich J. Use of induced sputum cell counts to investigate airway inflammation in asthma. Thorax. 1992 Jan;47(1):25-9. doi: 10.1136/thx.47.1.25.

Reference Type BACKGROUND
PMID: 1539140 (View on PubMed)

Margarit G, Belda J, Juarez C, Martinez C, Ramos A, Torrejon M, Granel C, Casan P, Sanchis J. [Total IgE in the sputum and serum of patients with asthma]. Allergol Immunopathol (Madr). 2005 Jan-Feb;33(1):48-53. doi: 10.1157/13070609. Spanish.

Reference Type BACKGROUND
PMID: 15777524 (View on PubMed)

Korn S, Haasler I, Fliedner F, Becher G, Strohner P, Staatz A, Taube C, Buhl R. Monitoring free serum IgE in severe asthma patients treated with omalizumab. Respir Med. 2012 Nov;106(11):1494-500. doi: 10.1016/j.rmed.2012.07.010. Epub 2012 Aug 11.

Reference Type BACKGROUND
PMID: 22884459 (View on PubMed)

Vega JM, Badia X, Badiola C, Lopez-Vina A, Olaguibel JM, Picado C, Sastre J, Dal-Re R; Covalair Investigator Group. Validation of the Spanish version of the Asthma Control Test (ACT). J Asthma. 2007 Dec;44(10):867-72. doi: 10.1080/02770900701752615.

Reference Type BACKGROUND
PMID: 18097865 (View on PubMed)

Plaza Moral V; Comite Ejecutivo de GEMA. [GEMA(4.0). Guidelines for Asthma Management]. Arch Bronconeumol. 2015 Jan;51 Suppl 1:2-54. doi: 10.1016/S0300-2896(15)32812-X. Epub 2015 Nov 30. No abstract available. Spanish.

Reference Type BACKGROUND
PMID: 26707419 (View on PubMed)

Crespo-Lessmann A, Curto E, Mateus E, Soto L, Garcia-Moral A, Torrejon M, Belda A, Giner J, Ramos-Barbon D, Plaza V. Total and specific immunoglobulin E in induced sputum in allergic and non-allergic asthma. PLoS One. 2020 Jan 29;15(1):e0228045. doi: 10.1371/journal.pone.0228045. eCollection 2020.

Reference Type DERIVED
PMID: 31995587 (View on PubMed)

Related Links

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http://www.gemasma.com.

Spanish guideline of Asthma

Other Identifiers

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IIBSP-ASM-2014-66

Identifier Type: -

Identifier Source: org_study_id

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