Development of "T-sec" Questionnaire

NCT ID: NCT05546645

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma

Keywords

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Asthma Hypersecretion Sputum

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaire

Hypersecretion questionnaire

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Astrid Crespo-Lessmann, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Esther Palones, MD

Role: CONTACT

Phone: +34 93 556 56 01

Email: [email protected]

Astrid Crespo-Lessmann, PhD

Role: CONTACT

Phone: +34 93 556 56 01

Email: [email protected]

Facility Contacts

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Astrid Crespo, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21121836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16371599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19059283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12122108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9780339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1555462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11179133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29414449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8430966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 629481 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8662868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33314245 (View on PubMed)

Other Identifiers

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IIBSP-TSC-2022-09

Identifier Type: -

Identifier Source: org_study_id