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

February 14, 2024 updated by: BRAIDO, Ospedale Policlinico San Martino

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy, 16132
        • IRCCS San Martino

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

patients (>18 years) suffering from RCC (Residual Cough VAS:>10/100 mm)

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Cough Impact Questionnaire (CCIQ)
Time Frame: february 2023
To develop the preliminary CCPP questionnaire starting from Chronic Cough Impact Questionnaire (CCIQ) (2) and available database
february 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Cough Impact Questionnaire (CCIQ)
Time Frame: August 2023
Assessment of refractory chronic cough (RCC) or unexplained chronic cough impact on HRQoL of the explored population and relationship with clinical variables
August 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Policlinico San Martino

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)

December 1, 2022

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

November 10, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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