ClinicalTrials.gg
RecruitingNCT06669897Updated Sep 15, 2025

Validation of a Questionnaire to Measure Cough Severity

An observational study in Cough, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 6 sites in Spain. Open to participants aged 30 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-15.

Primary conditionChronic CoughRegistry: CoughReclassifiedWhy we changed it
Registry
Cough — the first condition term the registry derived for this study.
ClinicalTrials.gg
Chronic Cough
Why
  1. The study's title name Chronic Cough, a narrower term within Cough.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
30 Years to 99 Years
Sex
All
01

Study summary

To design and validate a questionnaire that allows objective assessment of the severity of chronic cough

Read the detailed description

Chronic cough is a common disease that has important consequences for patients, ranging from physical to psychological and social aspects. However, there is currently no tool to objectively validate cough severity.

The aim of the study is to design and validate a questionnaire to objectively assess the severity of chronic cough.

02

Conditions studied

  • Cough

Browse trials for

Keywords

  • Cough
  • Chronic cough
03

In context

Chronic Cough Reclassified

142 studies on the registry are indexed under Chronic Cough; 39 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 37 observational studies indexed under Chronic Cough.

Browse Chronic Cough studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 343 studies on the registry; 65 are open to participants now.

Compared within Chronic Cough, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cough. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
30 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Spanish-speaking patients with previous diagnosis of chronic cough or healthy volunteers.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged between 30 and 99 years
  • Clinical diagnosis of chronic cough or healthy volunteers
  • Good understanding of Spanish

Exclusion criteria

Exclusion Criteria:

  • Non-Spanish-speaking patients
  • Inability to complete the questionnaires
  • Failure to sign the form
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Questionnaire

    Chronic cough

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    Chronic cough questionnaire

06

What researchers measure

Primary outcomes

  1. A questionnaire for assessing the severity of chronic cough

    To design and validate a questionnaire to objectively assess the severity of chronic cough

    Time frame: 1 year

Secondary outcomes

  1. Correlation of the results of the questionnaire with frequency of cough

    Perform a statistical analysis to determine the correlation of the results of the questionnaire with frequency of cough

    Time frame: 1 year

07

Study locations

6 of 6 sites recruiting
08

References and documents

Publications

  • French CT, Irwin RS, Fletcher KE, Adams TM. Evaluation of a cough-specific quality-of-life questionnaire. Chest. 2002 Apr;121(4):1123-31. doi: 10.1378/chest.121.4.1123. PubMed 11948042 ↗
  • McGarvey L, Gibson PG. What Is Chronic Cough? Terminology. J Allergy Clin Immunol Pract. 2019 Jul-Aug;7(6):1711-1714. doi: 10.1016/j.jaip.2019.04.012. Epub 2019 Apr 17. PubMed 31002958 ↗
  • Morice AH, McGarvey LP, Dicpinigaitis PV. Cough hypersensitivity syndrome is an important clinical concept: a pro/con debate. Lung. 2012 Feb;190(1):3-9. doi: 10.1007/s00408-011-9351-y. Epub 2011 Dec 22. PubMed 22186805 ↗
  • Haque RA, Usmani OS, Barnes PJ. Chronic idiopathic cough: a discrete clinical entity? Chest. 2005 May;127(5):1710-3. doi: 10.1378/chest.127.5.1710. PubMed 15888850 ↗
  • Song WJ, Chang YS, Faruqi S, Kim JY, Kang MG, Kim S, Jo EJ, Kim MH, Plevkova J, Park HW, Cho SH, Morice AH. The global epidemiology of chronic cough in adults: a systematic review and meta-analysis. Eur Respir J. 2015 May;45(5):1479-81. doi: 10.1183/09031936.00218714. Epub 2015 Feb 5. No abstract available. PubMed 25657027 ↗
  • Morice A. Chronic cough: epidemiology. Chron Respir Dis. 2008;5(1):43-7. doi: 10.1177/1479972307084252. PubMed 18303101 ↗
  • Irwin RS, Baumann MH, Bolser DC, Boulet LP, Braman SS, Brightling CE, Brown KK, Canning BJ, Chang AB, Dicpinigaitis PV, Eccles R, Glomb WB, Goldstein LB, Graham LM, Hargreave FE, Kvale PA, Lewis SZ, McCool FD, McCrory DC, Prakash UBS, Pratter MR, Rosen MJ, Schulman E, Shannon JJ, Hammond CS, Tarlo SM. Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):1S-23S. doi: 10.1378/chest.129.1_suppl.1S. No abstract available. PubMed 16428686 ↗

Individual participant data

Plan to share: Undecided — Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06669897
Responsible party
Sponsor
First posted
Nov 1, 2024
Start date
May 1, 2025
Primary completion
Nov 2025 (estimated)
Completion
Apr 2026 (estimated)
Last update
Sep 15, 2025

Study contacts

Astrid Crespo-Lessmann, PhD
Contact
acrespo@santpau.cat
+34 93 556 56 01
Astrid Crespo, PhD
Contact
acrespo@santpau.cat
+34 93 556 56 01
Astrid Crespo-Lessmann, PhD
principal investigator · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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