CoughNCT05034367
Reference Ranges for the Cough Responsiveness to Inhaled Mannitol
A study testing Mannitol challenge in people with Cough, run by Kuopio University Hospital at 2 sites in 2 countries.
Trial summary
Cough is the most common reason why people seek medical attention in developed countries. The main mechanisms for prolonged cough are hypersensitivity of the cough reflex arc, sputum production, and constriction of the airway smooth muscles. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- Mannitol challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Jan 2022to 31 Dec 2023
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older
- capable to understand the purpose of the study
- female/male ratio approximately 50%/50% in both of the following age groups:
- 50% aged 18- 50 yrs, and 50 % aged 51 - 90 years
Who cannot join
- Current daily smoking
- Ex-smoking with a greater than 10 pack years' daily smoking history or with stopping of daily smoking less than one year ago
- Pregnancy and breastfeeding
- A doctor's diagnosis of any respiratory diseases, including both upper and lower airway diseases, lung parenchymal diseases and the sleep apnoea syndrome
- A doctor's diagnosis of gastro-oesophageal reflux disease or symptoms suggestive of it
- Current use of angiotensin-converting enzyme inhibitors
Show all 16Show fewer
- Upper respiratory tract infection ('flu') within 4 weeks
- Any current (within 4 weeks) cough 8
- Chronic (over 2 months' duration) cough during the last 12 months
- Wheezing during the last 12 months
- Attacks of shortness of breath or cough at night during the last 12 months
- Symptoms of rhinitis in a prolonged fashion during the last 12 months
- Heartburn or regurgitation once a week or more often during the last 3 months
- Abnormal anatomy of the respiratory organs, which may affect the deposition of the mannitol powder
- Any previous operations to the respiratory organs that can affect the deposition of the mannitol powder
- Unable to provide written informed consent to participate in the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Cough is the most common reason why people seek medical attention in developed countries. The main mechanisms for prolonged cough are hypersensitivity of the cough reflex arc, sputum production, and constriction of the airway smooth muscles. Recognition of the mechanism in each cough patient is essential for the efficient management of prolonged cough. At present, there are no feasible tests for everyday clinical work to recognize cough reflex arc hypersensitivity.
Mannitol test was originally developed for asthma diagnostics. We have recently shown that it can also be used to investigate hypersensitive cough reflex arc. The purpose of the present study is to create reference ranges for normal cough responsiveness to inhaled mannitol. Without them, the test cannot be utilized in everyday clinical work. For that purpose we will perform mannitol test in 140 subjects, who are at least 18 years old and without any chronic respiratory symptoms or disorders. The subjects will be recruited in three centers: University of Eastern Finland and: John Hunter Hospital in Australia.The material will be collected 1.9.2021-31.12.2023. We apply funding for both personnel and material expences, to carry out this study.
- Conditions
- Cough
- Being tested
- Mannitol challenge
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mannitol challengeDiagnostic test
Inhalation challenge with dry powder of mannitol with a maximal cumulative dose of 635 mg
| Study group | Role | What they receive |
|---|---|---|
| Healthy persons | Experimental | The responses of the healthy subjects are utilized to create reference ranges for a normal cough response to mannitol Receives: Diagnostic Test: Mannitol challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough-to-dose ratio
calculated as the number of coughs per 100 mg of total cumulative dose of mannitol
Measured: Coughs are recorded during the 60 seconds after each mannitol dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start17 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- John Hunter Hospital
- Responsible party
- Principal investigator, Heikki Koskela, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034367
- Sponsor's protocol ID
- 5801151
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nurmi HM, Latti AM, Koskela HO. The Cough Response to Inhaled Mannitol in Healthy Subjects. Lung. 2024 Nov 28;203(1):5. doi: 10.1007/s00408-024-00755-6.
PubMed 39607505
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Ranges for the Cough Responsiveness to Inhaled Mannitol
- ClinicalTrials.gov ID
- NCT05034367
- Acronym / sponsor ID
- 5801151
- Conditions
- Cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- John Hunter Hospital
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Sep 2021 (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.
Cough is the most common reason why people seek medical attention in developed countries. The main mechanisms for prolonged cough are hypersensitivity of the cough reflex arc, sputum production, and constriction of the airway smooth muscles. Recognition of the mechanism in each cough patient is essential for the efficient management of prolonged cough. At present, there are no feasible tests for everyday clinical work to recognize cough reflex arc hypersensitivity.
Mannitol test was originally developed for asthma diagnostics. We have recently shown that it can also be used to investigate hypersensitive cough reflex arc. The purpose of the present study is to create reference ranges for normal cough responsiveness to inhaled mannitol. Without them, the test cannot be utilized in everyday clinical work. For that purpose we will perform mannitol test in 140 subjects, who are at least 18 years old and without any chronic respiratory symptoms or disorders. The subjects will be recruited in three centers: University of Eastern Finland and: John Hunter Hospital in Australia.The material will be collected 1.9.2021-31.12.2023. We apply funding for both personnel and material expences, to carry out this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy persons | Experimental | Diagnostic Test: Mannitol challengeThe responses of the healthy subjects are utilized to create reference ranges for a normal cough response to mannitol |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- capable to understand the purpose of the study
- female/male ratio approximately 50%/50% in both of the following age groups:
- 50% aged 18- 50 yrs, and 50 % aged 51 - 90 years
Key exclusion criteria (16 listed)
- Current daily smoking
- Ex-smoking with a greater than 10 pack years' daily smoking history or with stopping of daily smoking less than one year ago
- Pregnancy and breastfeeding
- A doctor's diagnosis of any respiratory diseases, including both upper and lower airway diseases, lung parenchymal diseases and the sleep apnoea syndrome
- A doctor's diagnosis of gastro-oesophageal reflux disease or symptoms suggestive of it
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 |
|---|---|---|
| Mannitol challengeInhalation challenge with dry powder of mannitol with a maximal cumulative dose of 635 mg | Diagnostic test | Healthy persons |
Primary outcome
Cough-to-dose ratio
Time frame: Coughs are recorded during the 60 seconds after each mannitol dose
calculated as the number of coughs per 100 mg of total cumulative dose of mannitol
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 19 Sep 2024.
- Derived from this study: PubMed 39607505Nurmi HM, Latti AM, Koskela HO. The Cough Response to Inhaled Mannitol in Healthy Subjects. Lung. 2024 Nov 28;203(1):5. doi: 10.1007/s00408-024-00755-6.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mannitol challenge in people with Cough, run by Kuopio University Hospital at 2 sites in 2 countries.
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 16 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, 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?
Cough-to-dose ratio (time frame: Coughs are recorded during the 60 seconds after each mannitol dose). 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 NCT05034367, 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 19 Sep 2024.