Study for the Development and Validation of Chronic Cough Patient Perspective Questionnaire

Chronic Cough Clinical Trial

— MISP  

Official title:

Retrospective and Prospective Observational Study for the Development and Validation of Chronic Cough Patient Perspective Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05642559
• Other study ID #: 22/2022
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2024
• Source: Ospedale Policlinico San Martino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Starting from Chronic Cough Impact Querstionnaire (CCIQ), of which we are the authors and copyright holders, it will be developed and validated a shortened version with psychometric properties allowing the use in the evaluation of single patient (Chronic Cough Patient Perspective).

The CCPP will allow to unmask the problem, reduce underdiagnosis, increase awareness on chronic cough, measure the impact of the chronic cough and its treatments on the patient's life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

diagnosis of RCC (Residual Cough VAS:>10/100 mm) according to ERS guidelines

Exclusion Criteria:

difficulty in understanding the italian language in both spoken and written form

Related Conditions & MeSH terms

• Chronic Cough
• Cough

Intervention

Other:
• questionnaire
Assessment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) impact on HRQoL of the explored population and relationship with clinical variables. Development of a web application of the questionnaire.

Locations

Country	Name	City	State
Italy	IRCCS San Martino	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic Cough Impact Questionnaire (CCIQ)	To develop the preliminary CCPP questionnaire starting from Chronic Cough Impact Questionnaire (CCIQ) (2) and available database	february 2023
Secondary	Chronic Cough Impact Questionnaire (CCIQ)	Assessment of refractory chronic cough (RCC) or unexplained chronic cough impact on HRQoL of the explored population and relationship with clinical variables	August 2023