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NCT05546645 Clinical Trial

Development of "T-sec" Questionnaire

Asthma Clinical Trial

— T-sec  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05546645
Other study ID # IIBSP-TSC-2022-09
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date March 2024

Study information
Verified date March 2023
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact Esther Palones, MD
Phone +34 93 556 56 01
Email epalones@santpau.cat
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 2024
Est. primary completion date January 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire
Hypersecretion questionnaire

Locations
Country Name City State
Spain Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90. Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Aikawa T, Shimura S, Sasaki H, Ebina M, Takishima T. Marked goblet cell hyperplasia with mucus accumulation in the airways of patients who died of severe acute asthma attack. Chest. 1992 Apr;101(4):916-21. doi: 10.1378/chest.101.4.916. — View Citation

Carroll N, Elliot J, Morton A, James A. The structure of large and small airways in nonfatal and fatal asthma. Am Rev Respir Dis. 1993 Feb;147(2):405-10. doi: 10.1164/ajrccm/147.2.405. — View 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. — View Citation

Evans CM, Koo JS. Airway mucus: the good, the bad, the sticky. Pharmacol Ther. 2009 Mar;121(3):332-48. doi: 10.1016/j.pharmthera.2008.11.001. Epub 2008 Nov 18. — View Citation

Fahy JV, Dickey BF. Airway mucus function and dysfunction. N Engl J Med. 2010 Dec 2;363(23):2233-47. doi: 10.1056/NEJMra0910061. No abstract available. — View Citation

Fleury Y, Dayem MA, Montagne JJ, Chaboisseau E, Le Caer JP, Nicolas P, Delfour A. Covalent structure, synthesis, and structure-function studies of mesentericin Y 105(37), a defensive peptide from gram-positive bacteria Leuconostoc mesenteroides. J Biol Chem. 1996 Jun 14;271(24):14421-9. doi: 10.1074/jbc.271.24.14421. — View Citation

Lange P, Parner J, Vestbo J, Schnohr P, Jensen G. A 15-year follow-up study of ventilatory function in adults with asthma. N Engl J Med. 1998 Oct 22;339(17):1194-200. doi: 10.1056/NEJM199810223391703. — View Citation

Lopez-Vidriero MT, Reid L. Chemical markers of mucous and serum glycoproteins and their relation to viscosity in mucoid and purulent sputum from various hypersecretory diseases. Am Rev Respir Dis. 1978 Mar;117(3):465-77. doi: 10.1164/arrd.1978.117.3.465. — View 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. — View Citation

Ordonez CL, Khashayar R, Wong HH, Ferrando R, Wu R, Hyde DM, Hotchkiss JA, Zhang Y, Novikov A, Dolganov G, Fahy JV. Mild and moderate asthma is associated with airway goblet cell hyperplasia and abnormalities in mucin gene expression. Am J Respir Crit Care Med. 2001 Feb;163(2):517-23. doi: 10.1164/ajrccm.163.2.2004039. — View Citation

Rose MC, Voynow JA. Respiratory tract mucin genes and mucin glycoproteins in health and disease. Physiol Rev. 2006 Jan;86(1):245-78. doi: 10.1152/physrev.00010.2005. — View Citation

Walter MJ, Morton JD, Kajiwara N, Agapov E, Holtzman MJ. Viral induction of a chronic asthma phenotype and genetic segregation from the acute response. J Clin Invest. 2002 Jul;110(2):165-75. doi: 10.1172/JCI14345. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary A questionnaire for bronchial mucus hypersecretion To design and validate a questionnaire to objectively assess the level of bronchial mucus hypersecretion 1 year
Secondary Correlation of the results of the questionnaire with exacerbations Perform a statistical analysis to determine the correlation of the results of the questionnaire with exacerbations 1 year
Secondary Correlation of the results of the questionnaire with FEV1 Perform a statistical analysis to determine the correlation of the results of the questionnaire with FEV1 1 year
Secondary Correlation of the results of the questionnaire with ACT Perform a statistical analysis to determine the correlation of the results of the questionnaire with FEV1 1 year
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