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AsthmaT-secNCT05546645

Development of "T-sec" Questionnaire

An observational study of Asthma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To design and validate a questionnaire that allows objective assessment of the level of bronchial mucus hypersecretion. Read more about this study

Who is it for?
Ages 30 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
Questionnaire
How many people
100 participants
Where
1 siteSpain
Study dates
1 Oct 2023to Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with asthma

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Esther Palones, MD contact

+34 93 556 56 01 ext. 5971

epalones@santpau.cat

Astrid Crespo-Lessmann, PhD contact

+34 93 556 56 01

acrespo@santpau.cat

Spain1 site, 1 recruiting

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

    Barcelona, 08041

    Astrid Crespo, MD, +34-935565972, acrespo@santpau.cat

    Recruiting

Other trials in Spain

About this study

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

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

Read the 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.

Conditions
Asthma
Being tested
Questionnaire
Keywords
Asthma, Hypersecretion, Sputum
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    Hypersecretion questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A questionnaire for bronchial mucus hypersecretion

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

    Measured: 1 year

Secondary outcomes (3)

  1. 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

    Measured: 1 year

  2. 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

    Measured: 1 year

  3. 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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2022
  2. Study start1 Oct 2023
  3. Primary completionJan 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05546645
Sponsor's protocol ID
IIBSP-TSC-2022-09
Acronym
T-sec
Status last verified
Mar 2023
First submitted
15 Sep 2022
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Publications

  • 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.

    PubMed 21121836

  • 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.

    PubMed 16371599

  • 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.

    PubMed 19059283

  • 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.

    PubMed 12122108

  • 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.

    PubMed 9780339

  • 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.

    PubMed 1555462

  • 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.

    PubMed 11179133

  • 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.

    PubMed 29414449

  • 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.

    PubMed 8430966

  • 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.

    PubMed 629481

  • 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.

    PubMed 8662868

  • 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.

    PubMed 33314245

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Esther Palones, MD (+34 93 556 56 01 ext. 5971, epalones@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A questionnaire for bronchial mucus hypersecretion (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05546645, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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Development of "T-sec" Questionnaire (NCT05546645) | AzTrials