Chronic CoughNCT03639727
Cough in Eastern and Central Finland
A study testing Citric acid aerosol bronchial challenge and Mannitol aerosol bronchial challenge in people with Chronic Cough, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Comparison of citric acid and mannitol cough provocation tests among subjects with chronic cough and healthy volunteers. 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?
- Citric acid aerosol bronchial challenge and Mannitol aerosol bronchial challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2018to 31 Jan 2019
- Phase
- Interventional
- 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
Who may be able to join
- (both criteria must be fulfilled)
- presence of current chronic cough (> 8 weeks)
- Leicester Cough Questionnaire total score < 17
- absence of any form of cough
Who cannot join
- age < 18 years
- any disability which would challenge the subject's ability to understand the purpose and methods of the study
- pregnancy
- breastfeeding
- current smoking or ex smoking more than 10 pack years
- any thoracic x-ray finding indicating urgent mediacal interventions
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of citric acid and mannitol cough provocation tests among subjects with chronic cough and healthy volunteers.
Read the detailed description
35 subjects with chronic cough plus 25 subjects without any cough will be asked to participate. The study consists of two visits in the outpatient clinic of Kuopio University Hospital, department of respiratory medicine, 2 - 7 days apart. They will fill in the Leicester Cough Questionnaire and undergo two different cough provocation tests, in random order: Mannitol test and citric acid test. If a chest x-ray has not been taken within 6 months, it will be taken.
- Conditions
- Chronic Cough
- Being tested
- Citric acid aerosol bronchial challenge, Mannitol aerosol bronchial challenge
- Keywords
- cough, cough provocation test, mannitol, citric acid
- Medical subject headings
- Chronic Cough, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citric acid aerosol bronchial challengeDiagnostic test
Inhalation challenge by citric acid aerosol to investigate the subject's cough sensitivity
Mannitol aerosol bronchial challengeDiagnostic test
Inhalation challenge by mannitol aerosol to investigate the subject's cough sensitivity
| Study group | Role | What they receive |
|---|---|---|
| Citric acid aerosol bronchial challenge | Active comparator | Inhaled citric acid aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is citric acid aerosol challenge. Receives: Diagnostic Test: Citric acid aerosol bronchial challenge |
| Mannitol aerosol bronchial challenge | Active comparator | Inhaled mannitol aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is mannitol aerosol challenge. Receives: Diagnostic Test: Mannitol aerosol bronchial challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receiver operator characteristic curves of the citric acid and the mannitol aerosol bronchial challenges
Receiver operator characteristic curve describes the ability of the bronchial challenge to separate the cough patients from healthy volunteers
Measured: Within one week from the start of the study in each individual
Secondary outcomes (1)
Leicester Cough Questionnaire total score
Measures cough-spesific quality of life. Range is 3 - 21 with low total score indicating poor cough-spesific quality of life. The three Leicester Cough Questionnaire subscales are added together to form the total score.
Measured: The first study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study compares citric acid and mannitol bronchial challenges in their ability to separate chronic cough subjects from healthy subjects. There are no therapeutic interventions.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Heikki Koskela, Kuopio University Hospital
- Investigators
- Heikki O Koskela, MD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639727
- Sponsor's protocol ID
- KUH5801136
- Status last verified
- Feb 2019
- First submitted
- 9 Aug 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pautola HVT, Koskela HO, Purokivi MK, Kaulamo JT, Latti AM. The prevalence and risk factors of respiratory symptoms in Finland: a comparative analysis. Eur Clin Respir J. 2025 Sep 25;12(1):2563395. doi: 10.1080/20018525.2025.2563395. eCollection 2025.
PubMed 41020184
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cough in Eastern and Central Finland
- ClinicalTrials.gov ID
- NCT03639727
- Acronym / sponsor ID
- KUH5801136
- Conditions
- Chronic Cough
- Keywords
- cough, cough provocation test, mannitol, citric acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 21 Aug 2018 (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.
Comparison of citric acid and mannitol cough provocation tests among subjects with chronic cough and healthy volunteers.
Detailed description
35 subjects with chronic cough plus 25 subjects without any cough will be asked to participate. The study consists of two visits in the outpatient clinic of Kuopio University Hospital, department of respiratory medicine, 2 - 7 days apart. They will fill in the Leicester Cough Questionnaire and undergo two different cough provocation tests, in random order: Mannitol test and citric acid test. If a chest x-ray has not been taken within 6 months, it will be taken.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study compares citric acid and mannitol bronchial challenges in their ability to separate chronic cough subjects from healthy subjects. There are no therapeutic interventions.
| Arm | Type | Receives |
|---|---|---|
| Citric acid aerosol bronchial challenge | Active comparator | Diagnostic Test: Citric acid aerosol bronchial challengeInhaled citric acid aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is citric acid aerosol challenge. |
| Mannitol aerosol bronchial challenge | Active comparator | Diagnostic Test: Mannitol aerosol bronchial challengeInhaled mannitol aerosol. This study investigates the diagnostic accuracy of two cough provocation tests, one of which is mannitol aerosol challenge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (both criteria must be fulfilled)
- presence of current chronic cough (> 8 weeks)
- Leicester Cough Questionnaire total score < 17
- absence of any form of cough
Key exclusion criteria (6 listed)
- age < 18 years
- any disability which would challenge the subject's ability to understand the purpose and methods of the study
- pregnancy
- breastfeeding
- current smoking or ex smoking more than 10 pack years
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 |
|---|---|---|
| Citric acid aerosol bronchial challengeInhalation challenge by citric acid aerosol to investigate the subject's cough sensitivity | Diagnostic test | Citric acid aerosol bronchial challenge |
| Mannitol aerosol bronchial challengeInhalation challenge by mannitol aerosol to investigate the subject's cough sensitivity | Diagnostic test | Mannitol aerosol bronchial challenge |
Primary outcome
Receiver operator characteristic curves of the citric acid and the mannitol aerosol bronchial challenges
Time frame: Within one week from the start of the study in each individual
Receiver operator characteristic curve describes the ability of the bronchial challenge to separate the cough patients from healthy volunteers
1 secondary outcome
Leicester Cough Questionnaire total score
Time frame: The first study day
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 12 Feb 2019.
- Derived from this study: PubMed 41020184Pautola HVT, Koskela HO, Purokivi MK, Kaulamo JT, Latti AM. The prevalence and risk factors of respiratory symptoms in Finland: a comparative analysis. Eur Clin Respir J. 2025 Sep 25;12(1):2563395. doi: 10.1080/20018525.2025.2563395. eCollection 2025.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
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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.
Heikki O Koskela, MD principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citric acid aerosol bronchial challenge and Mannitol aerosol bronchial challenge in people with Chronic Cough, run by Kuopio University Hospital at 1 site in Finland.
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 4 inclusion and 6 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 12 Feb 2019. 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 Finland. 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?
Receiver operator characteristic curves of the citric acid and the mannitol aerosol bronchial challenges (time frame: Within one week from the start of the study in each individual). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03639727, which also lists 1 linked publication.
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 12 Feb 2019.