Development of T-sec Questionnaire

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05546645

Acronym

T-sec

Enrollment

100

Registered

2022-09-21

Start date

2023-10-01

Completion date

2024-03-31

Last updated

2023-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Hypersecretion, Sputum

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.

Interventions

OTHERQuestionnaire

Hypersecretion questionnaire

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 99 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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 FEV1	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 ACT	1 year	Perform a statistical analysis to determine the correlation of the results of the questionnaire with FEV1

Countries

Spain

Contacts

Primary ContactEsther Palones, MD

epalones@santpau.cat+34 93 556 56 01

Backup ContactAstrid Crespo-Lessmann, PhD

acrespo@santpau.cat+34 93 556 56 01

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026