Validation of a Questionnaire to Measure Cough Severity | NCT06669897

Studies
Validation of a Questionnaire to Measure Cough Severity

NCT06669897

Sponsor

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

Status

Recruiting

Last Update Posted

Sep 15, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cough

Interventions

Questionnaire

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2025Actual

Primary Completion Date

Nov 2025Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Oct 31, 2024

First Submission Date that Met QC Criteria

Oct 31, 2024

First Posted Date

Nov 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2025

Last Update Posted Date

Sep 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Questionnaire		Chronic cough	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Chronic cough questionnaire	Questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A questionnaire for assessing the severity of chronic cough	To design and validate a questionnaire to objectively assess the severity of chronic cough	1 year

Secondary Outcomes

Measure	Description	Time Frame
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	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Astrid Crespo-Lessmann, PhD	Contact	+34 93 556 56 01		acrespo@santpau.cat
Astrid Crespo, PhD	Contact	+34 93 556 56 01		acrespo@santpau.cat

Overall Officials

Name	Affiliation	Role
Astrid Crespo-Lessmann, PhD	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Hermanos Trias y Pujol	Enrolling by invitation	Badalona	Barcelona	08916	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11948042	Background	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.
31002958	Background	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.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms