NCT03640936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

August 17, 2018

Last Update Submit

July 11, 2019

Conditions

Asthma

Keywords

asthmaallergyspecific IgE

Outcome Measures

Primary Outcomes (1)

  • Levels of specific IgE

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

    8 months

Secondary Outcomes (1)

  • Levels of total IgE

    8 months

Study Arms (3)

Healthy

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

Behavioral: Induced Sputum

Allergic asthma

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

Behavioral: Induced Sputum

Non-allergic asthma

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

Behavioral: Induced Sputum

Interventions

Induced SputumBEHAVIORAL

Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum

Allergic asthmaHealthyNon-allergic asthma

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with asthma without evidence of allergic disease.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Barcelona, 08041, Spain

Location

Related Publications (11)

  • 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.

    PMID: 15131563BACKGROUND

  • 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.

    PMID: 22561835BACKGROUND

  • 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.

    PMID: 26785727BACKGROUND

  • 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.

    PMID: 24332860BACKGROUND

  • 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.

    PMID: 24931597BACKGROUND

  • 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.

    PMID: 1539140BACKGROUND

  • 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.

    PMID: 15777524BACKGROUND

  • 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.

    PMID: 22884459BACKGROUND

  • 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.

    PMID: 18097865BACKGROUND

  • 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.

    PMID: 26707419BACKGROUND

  • 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.

    PMID: 31995587DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Supernatant of induced sputum

MeSH Terms

Conditions

AsthmaHypersensitivity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 21, 2018

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2019

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Locations

ES(1)