Mucins and Toll-like Receptors in Asthma

Asthma Clinical Trial

— MUCITOLL  

Official title:

Asthma With Bronchial Hypersecretion: Expression of Mucins and Toll-like Receptors in Sputum and Blood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948153
• Other study ID #: IIBSP-ROF-2011-106
• Status: Completed
• Phase: N/A
• First received: October 18, 2016
• Last updated: October 26, 2016
• Start date: January 2014
• Est. completion date: April 2016

Study information

• Verified date: September 2015
• 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: Observational

Clinical Trial 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.

Description:

Asthma with bronchial hypersecretion is a type of asthma poorly studied. Its pathogenesis is not well understood but probably is related to the innate impaired immunity, particularly with "toll-like receptors" (TLR) and secretory mucin (MUC).

Objectives 1) Define the clinical and inflammatory phenotype of asthma with bronchial hypersecretion of mucus. 2) Compare the type of mucin present in induced sputum (IS) of patients with and without bronchial hypersecretion. 3) Determine the expression of TLRs in the IS and in the peripheral blood of asthmatics with and without bronchial hypersecretion.

Method: Cross-sectional study which included 43 asthmatic patients, 19 with and 24 without bronchial hypersecretion. All patients underwent the following: IS, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin. Analysis of mucins (MUC2, MUC5AC, MUC5B and MUC1) was determined by ELISA and expression of TLR2 and TLR4 by flow cytometry. The level of asthma control was determined by the asthma control test questionnaire (ACT) and quality of life was assessed by the MiniAQLQ questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients were excluded from the study if they had a respiratory tract infection and/or required the use of oral corticosteroids within 30 days prior to inclusion; if they had a concomitant disease (sarcoidosis, lung cancer, pulmonary tuberculosis, bronchiectasis, nephropathy, rheumatic or liver disease); significant comorbidity that could affect the study results in the physician's judgment; or a cognitive impairment that could limit their comprehension of the subject under study or their ability to participate

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma
• Inflammation

Intervention

Other:
• clinical study
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

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.	Barcelona

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of asthmatic patients with bronchial hypersecretion		18 months	No
Secondary	Number of asthmatic patients with altered expression of TLRs		18 months	No
Secondary	Number of asthmatic patients with altered expression of Mucins		18 months	No