Clinical trial NCT03640936: Total IgE (Immunoglobulin E) and Der p 1 (d1) Specific IgE in Induced Sputum in Patients With Allergic and Non-allergic Asthma
Official title: Total IgE and Der p 1 (d1) Specific IgE in Induced Sputum in Patients With Allergic and Non-allergic Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
allergy
specific IgE
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with asthma without evidence of allergic disease.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Levels of specific IgE
timeFrame: 8 months
Secondary outcomes:
measure: Levels of total IgE
timeFrame: 8 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.