CoughNCT06669897
Validation of a Questionnaire to Measure Cough Severity
An observational study of Cough, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 6 sites in Spain.
Trial summary
To design and validate a questionnaire that allows objective assessment of the severity of chronic cough Read more about this study
- Who is it for?
- Ages 30 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- Questionnaire
- How many people
- 100 participants
- Where
- 6 sitesSpain
- Study dates
- 1 May 2025to Apr 2026
- 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: Spanish-speaking patients with previous diagnosis of chronic cough or healthy volunteers.
Who may be able to join
- Aged between 30 and 99 years
- Clinical diagnosis of chronic cough or healthy volunteers
- Good understanding of Spanish
Who cannot join
- Non-Spanish-speaking patients
- Inability to complete the questionnaires
- Failure to sign the informed consent form
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Enrolling by invitation
Hospital Universitario Hermanos Trias y Pujol
Badalona, Barcelona, 08916
- Recruiting
Hospital del Mar
Barcelona, 08003
Maria Pilar Ausin Herrero, MD, mpausin@psmar.cat
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Ebymar Arismendi, MD, 0, EARISMEN@clinic.cat
- Recruiting
Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
Barcelona, 08041
Astrid Crespo, MD, +34-935565972, acrespo@santpau.cat
- Recruiting
Hospital Univesitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Mariana Muñoz, MD, mmunoze@bellvitgehospital.cat
- Recruiting
Parc Taulí Hospital Universitari
Sabadell, Barcelona, 08208
Ana Sogo, MD, asogo@hotmail.com
About this study
Official title: Validation of a Questionnaire to Measure Cough Severity in Patients With Chronic Cough
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.
- Conditions
- Cough
- Being tested
- Questionnaire
- Keywords
- Cough, Chronic cough
- Medical subject headings
- Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Chronic cough questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Chronic cough Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
A questionnaire for assessing the severity of chronic cough
To design and validate a questionnaire to objectively assess the severity of chronic cough
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 May 2025
- Primary completionNov 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Astrid Crespo-Lessmann, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669897
- Sponsor's protocol ID
- IIBSP-TOS-2023-133
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
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 11948042McGarvey 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 31002958Morice 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 22186805Haque 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 15888850Song 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 25657027Morice A. Chronic cough: epidemiology. Chron Respir Dis. 2008;5(1):43-7. doi: 10.1177/1479972307084252.
PubMed 18303101Irwin 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Questionnaire to Measure Cough Severity in Patients With Chronic Cough
- ClinicalTrials.gov ID
- NCT06669897
- Acronym / sponsor ID
- IIBSP-TOS-2023-133
- Conditions
- Cough
- Keywords
- Cough, Chronic cough
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To design and validate a questionnaire that allows objective assessment of the severity of chronic cough
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | Other: QuestionnaireChronic cough |
Who may qualify
- Ages
- 30 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Spanish-speaking patients with previous diagnosis of chronic cough or healthy volunteers.
Key inclusion criteria (3 listed)
- Aged between 30 and 99 years
- Clinical diagnosis of chronic cough or healthy volunteers
- Good understanding of Spanish
Key exclusion criteria (3 listed)
- Non-Spanish-speaking patients
- Inability to complete the questionnaires
- Failure to sign the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireChronic cough questionnaire | Other | Questionnaire |
Primary outcome
A questionnaire for assessing the severity of chronic cough
Time frame: 1 year
To design and validate a questionnaire to objectively assess the severity of chronic cough
1 secondary outcome
Correlation of the results of the questionnaire with frequency of cough
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 11948042French 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.
- Background: PubMed 31002958McGarvey 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.
- Background: PubMed 22186805Morice 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.
- Background: PubMed 15888850Haque 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.
- Background: PubMed 25657027Song 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.
- Background: PubMed 18303101Morice A. Chronic cough: epidemiology. Chron Respir Dis. 2008;5(1):43-7. doi: 10.1177/1479972307084252.
- Background: PubMed 16428686Irwin 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.
- Individual participant dataSharing planned: Undecided. Undecided
Related trials for Cough
RecruitingPhase 2
The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)
Refractory Chronic Cough
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
RecruitingObservational study
Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
Cough
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Recruiting
Feasibility of Cough Skill Training in Individuals With Head and Neck Cancer
Head and Neck Cancers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid Crespo-Lessmann, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 6 sites 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 3 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Astrid Crespo-Lessmann, PhD (+34 93 556 56 01, acrespo@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 assessing the severity of chronic cough (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 NCT06669897, which also lists 7 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 15 Sep 2025.