NCT05642559

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

November 10, 2022

Last Update Submit

February 14, 2024

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Chronic Cough Impact Questionnaire (CCIQ)

    August 2023

Interventions

questionnaireOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Martino

Genova, 16132, Italy

Location

MeSH Terms

Conditions

Chronic Cough

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

CoughRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 10, 2022

First Posted

December 8, 2022

Study Start

December 1, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations

IT(1)