- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06669897
Validation of a Questionnaire to Measure Cough Severity
September 9, 2025 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
Study Overview
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 Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Astrid Crespo-Lessmann, PhD
- Phone Number: +34 93 556 56 01
- Email: acrespo@santpau.cat
Study Contact Backup
- Name: Astrid Crespo, PhD
- Phone Number: +34 93 556 56 01
- Email: acrespo@santpau.cat
Study Locations
-
-
-
Barcelona, Spain, 08003
- Recruiting
- Hospital del Mar
-
Contact:
- Maria Pilar Ausin Herrero, MD
- Email: mpausin@psmar.cat
-
Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic de Barcelona
-
Contact:
- Ebymar Arismendi, MD
- Email: EARISMEN@clinic.cat
-
Barcelona, Spain, 08041
- Recruiting
- Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
-
Contact:
- Astrid Crespo, MD
- Phone Number: +34-935565972
- Email: acrespo@santpau.cat
-
-
Barcelona
-
Badalona, Barcelona, Spain, 08916
- Enrolling by invitation
- Hospital Universitario Hermanos Trias y Pujol
-
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
- Recruiting
- Hospital Univesitario de Bellvitge
-
Contact:
- Mariana Muñoz, MD
- Email: mmunoze@bellvitgehospital.cat
-
Sabadell, Barcelona, Spain, 08208
- Recruiting
- Parc Tauli Hospital Universitari
-
Contact:
- Ana Sogo, MD
- Email: asogo@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Spanish-speaking patients with previous diagnosis of chronic cough or healthy volunteers.
Description
Inclusion Criteria:
- Aged between 30 and 99 years
- Clinical diagnosis of chronic cough or healthy volunteers
- Good understanding of Spanish
Exclusion Criteria:
- Non-Spanish-speaking patients
- Inability to complete the questionnaires
- Failure to sign the informed consent form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Questionnaire
Chronic cough
|
Chronic cough questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation of the results of the questionnaire with frequency of cough
Time Frame: 1 year
|
Perform a statistical analysis to determine the correlation of the results of the questionnaire with frequency of cough
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Astrid Crespo-Lessmann, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- Morice A. Chronic cough: epidemiology. Chron Respir Dis. 2008;5(1):43-7. doi: 10.1177/1479972307084252.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2025
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
October 31, 2024
First Submitted That Met QC Criteria
October 31, 2024
First Posted (Actual)
November 1, 2024
Study Record Updates
Last Update Posted (Estimated)
September 15, 2025
Last Update Submitted That Met QC Criteria
September 9, 2025
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Signs and Symptoms, Respiratory
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Chronic Cough
- Cough
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- IIBSP-TOS-2023-133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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