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Completed

NCT Number: NCT02948153

Mucins and Toll-like Receptors in Asthma

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Barcelona, 08041, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number of asthmatic patients with bronchial hypersecretion

    Time frame: 18 months

Secondary outcomes

  1. Number of asthmatic patients with altered expression of TLRs

    Time frame: 18 months

  2. Number of asthmatic patients with altered expression of Mucins

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Spanish Respiratory Society

Registry information

Official study title

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

Acronym: MUCITOLL

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 28, 2016
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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