Expression of Toll-Like Receptors 2 and 4 in Asthmatic Patients.

Asthma Clinical Trial

Official title:

Expression of Toll-Like Receptors 2 and 4 in Asthmatic Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028637
• Other study ID #: 43/2009
• Status: Completed
• Phase: N/A
• First received: January 3, 2014
• Last updated: January 4, 2014
• Start date: July 2009
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

Introduction: Recently it has involved the role of TLR (toll-like receptors) in the pathogenesis of asthma. TLRs are a family of proteins responsible for the recognition of Pathogen-Associated Molecular Patters (PAMPs). The possible role that TLRs play in IgE-dependent asthma (not eosinophilic) and its recognition as a new endotype asthma, could open new therapeutic expectations.

Objective: To analyze the expression of TLR 2 and 4 in monocytes/ macrophages and neutrophils in peripheral blood and induced sputum from asthmatic patients

Description:

The investigators studied patients with asthma. All patients underwent the same day an induced sputum, pulmonary function studies, fractional exhaled nitric oxide, blood total IgE and skin test by prick technique. Asthmatic patients were classified according to the criteria of the GINA 2012. The cellular composition was analyzed by flow cytometry. Expression of TLR2 and TLR4 were analyzed using monoclonal antibodies conjugated with fluorochromes appropriate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adults with persistent asthma (defined as per the Global INitiative for Asthma Management (GINA) criteria)

Exclusion Criteria:

• If they had a respiratory tract infection or asthma exacerbation within 30 days prior to inclusion

• If they were receiving oral steroids or immunosuppressive treatments.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• TLRs
Recently it has involved the role of TLR (toll-like receptors) in the pathogenesis of asthma.The possible role that TLRs play in the asthma and its recognition as a new endotype asthma, could open new therapeutic expectations.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Anderson GP. Endotyping asthma: new insights into key pathogenic mechanisms in a complex, heterogeneous disease. Lancet. 2008 Sep 20;372(9643):1107-19. doi: 10.1016/S0140-6736(08)61452-X. Review. — View Citation

Crespo-Lessmann A, Juárez-Rubio C, Plaza-Moral V. [Role of toll-like receptors in respiratory diseases]. Arch Bronconeumol. 2010 Mar;46(3):135-42. doi: 10.1016/j.arbres.2009.07.011. Epub 2009 Sep 17. Review. Spanish. — View Citation

Gon Y. Toll-like receptors and airway inflammation. Allergol Int. 2008 Mar;57(1):33-7. doi: 10.2332/allergolint.R-07-157. Epub 2008 Mar 1. Review. — View Citation

Simpson JL, Grissell TV, Douwes J, Scott RJ, Boyle MJ, Gibson PG. Innate immune activation in neutrophilic asthma and bronchiectasis. Thorax. 2007 Mar;62(3):211-8. Epub 2006 Jul 14. — View Citation

The ENFUMOSA cross-sectional European multicentre study of the clinical phenotype of chronic severe asthma. European Network for Understanding Mechanisms of Severe Asthma. Eur Respir J. 2003 Sep;22(3):470-7. — View Citation

Vidal S, Bellido-Casado J, Granel C, Crespo A, Plaza V, Juárez C. Flow cytometry analysis of leukocytes in induced sputum from asthmatic patients. Immunobiology. 2012 Jul;217(7):692-7. doi: 10.1016/j.imbio.2011.11.008. Epub 2011 Dec 2. — View Citation

Weiss ST. Eat dirt--the hygiene hypothesis and allergic diseases. N Engl J Med. 2002 Sep 19;347(12):930-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of neutrophils expressing TLR4 in induced sputum decreases in asthma not eosinophilic	The percentage of neutrophils expressing TLR4 in induced sputum decreases in asthma not eosinophilic (IgEnodep).This could suggest that in this type of asthma the defense mechanism of neutrophils could be altered by decreasing expression of these receptors on their cell surface. This mechanism would still be defined. Probably the respiratory infections play an important role.	2 years	Yes

External Links

•   Asthma