Development of "T-sec" Questionnaire

Recruiting

• Conditions: Asthma

• Registration Number: NCT05546645
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-21
• Status Verified: 2023-03
• Study Start: 2023-10-01
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-22
• Primary Completion: 2024-01
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A questionnaire for bronchial mucus hypersecretion	1 year	To design and validate a questionnaire to objectively assess the level of bronchial mucus hypersecretion

Secondary Outcome Measures

Name	Time	Method
Correlation of the results of the questionnaire with exacerbations	1 year	Perform a statistical analysis to determine the correlation of the results of the questionnaire with exacerbations
Correlation of the results of the questionnaire with ACT	1 year	Perform a statistical analysis to determine the correlation of the results of the questionnaire with FEV1
Correlation of the results of the questionnaire with FEV1	1 year	Perform a statistical analysis to determine the correlation of the results of the questionnaire with FEV1

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.; 🇪🇸 Barcelona, Spain