Mucins and Toll-like Receptors in Asthma

NCT02948153 | Completed

• 1 other identifier: IIBSP-ROF-2011-106
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study raises two main hypotheses: 1) Asthmatics patients who present with bronchial hypersecretion differ phenotypically from asthmatic patients without hypersecretion and 2) mucins in asthmatic patients with hypersecretion of bronchial mucus and the expression of TLRs differ from non-mucus hypersecretory asthmatics patients.

Conditions

Asthma; Inflammation

Outcome Measures

Primary Outcomes (1)

• Number of asthmatic patients with bronchial hypersecretion

  18 months

Secondary Outcomes (2)

• Number of asthmatic patients with altered expression of TLRs

  18 months

• Number of asthmatic patients with altered expression of Mucins

  18 months

Study Arms (2)

asthma with bronchial hypersecretion

In a clinical study, participants are often divided into groups. Group one: they were defined as those who expectorated daily for at least three months for a minimum period of two consecutive years, without attribution to any other cause or disease.

Other: clinical study

asthma without hypersecretion

In a clinical study, participants are often divided into groups. Group two: We defined asthma as a history of variable respiratory symptoms and evidence of variable expiratory airflow limitation.

Other: clinical study

Interventions

clinical study OTHER

It is a comprehensive study in a large sample using multiple techniques to assess various aspects of the disease. All patients underwent the following : Induced Sputum, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin. Analysis of mucins and TLRs

asthma with bronchial hypersecretion; asthma without hypersecretion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female subjects aged \> 18 years, non-smokers, who fulfilled the diagnostic criteria of asthma were consecutively enrolled from the Asthma Unit outpatient clinic of our institution. We defined asthma as a history of variable respiratory symptoms and evidence of variable expiratory airflow limitation. All patients had a positive bronchodilator test or daily peak expiratory flow variability greater than 20%, or a positive methacholine challenge test documented in case history. Asthma severity was defined according to the Global Initiative for Asthma Management (GINA)

You may qualify if:

• Non-smokers, asthma diagnosed as per the Global INitiative for Asthma (GINA) criteria on maintenance treatment for asthma, aged 18 to 80 years.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Spanish Respiratory Society: collaborator

Study Sites (1)

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

Barcelona, Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

Asthma; Inflammation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Astrid Crespo, MD,PHD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 28, 2016
• Study Start: January 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: April 1, 2016
• Last Updated: October 28, 2016

Record last verified: 2015-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)