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Mucins and Toll-like Receptors in Asthma (MUCITOLL)

26. oktober 2016 opdateret af: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

43

Kontakter og lokationer

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Studiesteder

  • Spanien
      • Barcelona, Spanien, 08041
        • Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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)

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: 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
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.
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of asthmatic patients with bronchial hypersecretion
Tidsramme: 18 months
18 months

Sekundære resultatmål

Resultatmål
Tidsramme
Number of asthmatic patients with altered expression of TLRs
Tidsramme: 18 months
18 months
Number of asthmatic patients with altered expression of Mucins
Tidsramme: 18 months
18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Samarbejdspartnere

Spanish Respiratory Society

Efterforskere

  • Ledende efterforsker: Astrid Crespo, MD,PHD, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2014

Primær færdiggørelse (Faktiske)

1. september 2015

Studieafslutning (Faktiske)

1. april 2016

Datoer for studieregistrering

Først indsendt

18. oktober 2016

Først indsendt, der opfyldte QC-kriterier

26. oktober 2016

Først opslået (Skøn)

28. oktober 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2016

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IIBSP-ROF-2011-106

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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