Development of "T-sec" Questionnaire

NCT05546645 | Unknown

• 1 other identifier: IIBSP-TSC-2022-09
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Asthma; Hypersecretion; Sputum

Outcome Measures

Primary Outcomes (1)

• A questionnaire for bronchial mucus hypersecretion

  To design and validate a questionnaire to objectively assess the level of bronchial mucus hypersecretion

  1 year

Secondary Outcomes (3)

• Correlation of the results of the questionnaire with exacerbations

  1 year

• Correlation of the results of the questionnaire with FEV1

  1 year

• Correlation of the results of the questionnaire with ACT

  1 year

Interventions

Questionnaire OTHER

Hypersecretion questionnaire

Eligibility Criteria

• Age: 30 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with asthma

You may qualify if:

• Aged between 30 and 99 years
• Clinical diagnosis of asthma

You may not qualify if:

• Non-Spanish-speaking patients
• Inability to complete the questionnaires
• Failure to sign the informed consent form.

Sponsors & Collaborators

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

Study Sites (1)

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

Barcelona, 08041, Spain

RECRUITING

Related Publications (12)

• 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.

  PMID: 21121836 BACKGROUND

• 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.

  PMID: 16371599 BACKGROUND

• 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.

  PMID: 19059283 BACKGROUND

• 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.

  PMID: 12122108 BACKGROUND

• 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.

  PMID: 9780339 BACKGROUND

• 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.

  PMID: 1555462 BACKGROUND

• 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.

  PMID: 11179133 BACKGROUND

• 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.

  PMID: 29414449 BACKGROUND

• 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.

  PMID: 8430966 BACKGROUND

• 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.

  PMID: 629481 BACKGROUND

• 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.

  PMID: 8662868 BACKGROUND

• 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.

  PMID: 33314245 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Astrid Crespo-Lessmann, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Palones, MD

CONTACT

+34 93 556 56 01; epalones@santpau.cat

Astrid Crespo-Lessmann, PhD

CONTACT

+34 93 556 56 01; acrespo@santpau.cat

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: October 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-03

Locations

ES (1)