Clinical trial NCT05546645: Development of "T-sec" Questionnaire
Official title: Validation of a Questionnaire to Assess Bronchial Mucus Hypersecretion in Asthmatic Patients. Questionnaire "T-sec" (Secretion Test).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: Asthma
Hypersecretion
Sputum
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with asthma

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.

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.

Primary outcomes:
measure: A questionnaire for bronchial mucus hypersecretion
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of the results of the questionnaire with exacerbations
timeFrame: 1 year
measure: Correlation of the results of the questionnaire with FEV1
timeFrame: 1 year
measure: Correlation of the results of the questionnaire with ACT
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Astrid Crespo-Lessmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Martinez-Rivera C, Crespo A, Pinedo-Sierra C, Garcia-Rivero JL, Pallares-Sanmartin A, Marina-Malanda N, Pascual-Erquicia S, Padilla A, Mayoralas-Alises S, Plaza V, Lopez-Vina A, Picado C. Mucus hypersecretion in asthma is associated with rhinosinusitis, polyps and exacerbations. Respir Med. 2018 Feb;135:22-28. doi: 10.1016/j.rmed.2017.12.013. Epub 2018 Jan 3.
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citation: Crespo-Lessmann A, Plaza V; Consensus Group. Multidisciplinary consensus on sputum induction biosafety during the COVID-19 pandemic. Allergy. 2021 Aug;76(8):2407-2419. doi: 10.1111/all.14697. Epub 2021 Jan 19.