NCT02028637

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable asthma

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

July 1, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

4.2 years

First QC Date

January 3, 2014

Last Update Submit

January 4, 2014

Conditions

Keywords

asthmatoll like receptorinnate immunity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

toll like receptor (TLRs)

EXPERIMENTAL

TLRs are a family of proteins responsible for the recognition of Pathogen-Associated Molecular Patters

Other: TLRs

Interventions

TLRsOTHER

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.

toll like receptor (TLRs)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • If they were receiving oral steroids or immunosuppressive treatments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Related Publications (7)

  • 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. doi: 10.1183/09031936.03.00261903.

    PMID: 14516137BACKGROUND
  • 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.

    PMID: 18805339BACKGROUND
  • Weiss ST. Eat dirt--the hygiene hypothesis and allergic diseases. N Engl J Med. 2002 Sep 19;347(12):930-1. doi: 10.1056/NEJMe020092. No abstract available.

    PMID: 12239263BACKGROUND
  • 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.

    PMID: 18209505BACKGROUND
  • 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. doi: 10.1136/thx.2006.061358. Epub 2006 Jul 14.

    PMID: 16844729BACKGROUND
  • Crespo-Lessmann A, Juarez-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.

    PMID: 19765883BACKGROUND
  • Vidal S, Bellido-Casado J, Granel C, Crespo A, Plaza V, Juarez 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.

    PMID: 22204819BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Astrid Crespo

    Department of Respiratory Medicine, Hospital de la Santa Creu i Sant Pau. Institut d'Investigació Biomédica Sant Pau (IIB Sant Pau). Universitat Autònoma de Barcelona, Department of Medicine.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Respiratory Medicine, Hospital de la Santa Creu i Sant Pau. Institut d'Investigació Biomédica Sant Pau (IIB Sant Pau). Universitat Autònoma de Barcelona, Department of Medicine. Barcelona Respiratory Network (BRN). Barcelona, Spain.

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 7, 2014

Study Start

July 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations