Development of "T-sec" Questionnaire (T-sec)

December 19, 2023 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with asthma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of the results of the questionnaire with exacerbations
Time Frame: 1 year
Perform a statistical analysis to determine the correlation of the results of the questionnaire with exacerbations
1 year
Correlation of the results of the questionnaire with FEV1
Time Frame: 1 year
Perform a statistical analysis to determine the correlation of the results of the questionnaire with FEV1
1 year
Correlation of the results of the questionnaire with ACT
Time Frame: 1 year
Perform a statistical analysis to determine the correlation of the results of the questionnaire with FEV1
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-TSC-2022-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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