Development of "T-sec" Questionnaire

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05546645
Collaborator
(none)
100
12.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Validation of a Questionnaire to Assess Bronchial Mucus Hypersecretion in Asthmatic Patients. Questionnaire "T-sec" (Secretion Test).
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Astrid Crespo-Lessmann, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT05546645
Other Study ID Numbers:
  • IIBSP-TSC-2022-09
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 22, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2022