Chronic CoughMISPNCT05642559
Study for the Development and Validation of Chronic Cough Patient Perspective Questionnaire
An observational study of Chronic Cough, run by Ospedale Policlinico San Martino at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Cough
- What is being tested?
- questionnaire
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients (>18 years) suffering from RCC (Residual Cough VAS:>10/100 mm)
Who may be able to join
- diagnosis of RCC (Residual Cough VAS:>10/100 mm) according to ERS guidelines
Who cannot join
- difficulty in understanding the italian language in both spoken and written form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Cough
- Being tested
- questionnaire
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Cough Impact Questionnaire (CCIQ)
To develop the preliminary CCPP questionnaire starting from Chronic Cough Impact Questionnaire (CCIQ) (2) and available database
Measured: february 2023
Secondary outcomes (1)
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
Measured: August 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Dec 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BRAIDO, Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642559
- Sponsor's protocol ID
- 22/2022
- Acronym
- MISP
- Status last verified
- Feb 2024
- First submitted
- 10 Nov 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Observational Study for the Development and Validation of Chronic Cough Patient Perspective Questionnaire
- ClinicalTrials.gov ID
- NCT05642559
- Acronym / sponsor ID
- MISP / 22/2022
- Conditions
- Chronic Cough
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients (>18 years) suffering from RCC (Residual Cough VAS:>10/100 mm)
Key inclusion criteria (1 listed)
- diagnosis of RCC (Residual Cough VAS:>10/100 mm) according to ERS guidelines
Key exclusion criteria (1 listed)
- difficulty in understanding the italian language in both spoken and written form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireAssessment 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. | Other | – |
Primary outcome
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
1 secondary outcome
Chronic Cough Impact Questionnaire (CCIQ)
Time frame: August 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Cough, run by Ospedale Policlinico San Martino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Cough Impact Questionnaire (CCIQ) (time frame: february 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.