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Clinical Trials/NCT05546645
NCT05546645
Recruiting
Not Applicable

Validation of a Questionnaire to Assess Bronchial Mucus Hypersecretion in Asthmatic Patients. Questionnaire "T-sec" (Secretion Test).

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country100 target enrollmentOctober 1, 2023
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment
100
Locations
1
Primary Endpoint
A questionnaire for bronchial mucus hypersecretion
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

To design and validate a questionnaire that allows objective assessment of the level of bronchial mucus hypersecretion.

Detailed Description

Asthma is a chronic inflammatory disease associated with bronchial mucus hypersecretion (MBH) due to various mechanisms, such as increased mucin secretion, plasma exudation and cytokines. It is currently known that MBH in asthmatic patients is associated with increased mortality and reduced pulmonary function, but there is no tool for its objective assessment. The aim of the study is to design and validate a questionnaire to objectively assess the level of bronchial mucus hypersecretion in patients with asthma.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
March 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • Aged between 30 and 99 years
  • Clinical diagnosis of asthma

Exclusion Criteria

  • Non-Spanish-speaking patients
  • Inability to complete the questionnaires
  • Failure to sign the informed consent form.

Outcomes

Primary Outcomes

A questionnaire for bronchial mucus hypersecretion

Time Frame: 1 year

To design and validate a questionnaire to objectively assess the level of bronchial mucus hypersecretion

Secondary Outcomes

  • Correlation of the results of the questionnaire with exacerbations(1 year)
  • Correlation of the results of the questionnaire with ACT(1 year)
  • Correlation of the results of the questionnaire with FEV1(1 year)

Study Sites (1)

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