Cough Reflex SensitivityNCT07531901
Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid
A study testing DeVilbiss 45 Handheld Nebulizer in people with Cough Reflex Sensitivity, run by University of Montana at 1 site in United States.
Trial summary
Objective cough reflex sensitivity testing is typically restricted to specialized research laboratories due to reliance on expensive dosimeter-controlled aerosol delivery systems. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough Reflex Sensitivity
- What is being tested?
- DeVilbiss 45 Handheld Nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults at least 18 years of age
- Consent to audio/video recording of the research sessions for research purposes
- Spirometry testing results obtained by study team on same day of first testing session with FEV1/FVC ratio and FEV1 percent predicted values of at least 0.70
Who cannot join
- Pregnant or trying to become pregnant (if capable of becoming pregnant- a urine pregnancy test will be provided onsite and a negative result must be obtained prior to the first testing session)
- Smoking of any substance in the last six months
- Diagnosed or suspected pulmonary disease (e.g., asthma, COPD)
- History of chronic cough
- History of head or neck cancer
- History of neurological disease (e.g., cerebrovascular accident)
Show all 9Show fewer
- History of dysphagia (swallowing difficulty)
- Current complaint of a voice problem
- Current upper respiratory infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Montana
Missoula, Montana, 59812
Jane E Salois, PhD, 406-243-2138, jane.salois@umontana.edu
Jane E Salois, PhD
About this study
Objective cough reflex sensitivity testing is typically restricted to specialized research laboratories due to reliance on expensive dosimeter-controlled aerosol delivery systems. This study evaluates the feasibility and reliability of a low-cost alternative method using a handheld nebulizer for citric acid cough challenge testing. Healthy adult participants will complete cough reflex sensitivity testing using both a standard dosimeter-controlled nebulizer system (Cosmed QuarkSpiro) and a handheld nebulizer (DeVilbiss 45). The study will compare cough threshold outcomes between methods to determine whether handheld nebulizer-based testing produces comparable and reproducible measurements.
Read the detailed description
Cough reflex sensitivity testing is widely used in respiratory research to quantify airway sensory responsiveness. Traditional testing protocols use dosimeter-controlled nebulizer systems to deliver precise concentrations of aerosolized tussive agents such as citric acid. However, these systems are costly and require specialized laboratory infrastructure, limiting access to objective cough testing in outpatient and community-based settings.
This study investigates the feasibility and reliability of using a commercially available handheld nebulizer as a low-cost alternative for cough reflex sensitivity testing. Healthy adult volunteers will undergo standardized cough challenge testing using citric acid delivered through two aerosol delivery systems: a laboratory dosimeter-controlled nebulizer (Cosmed QuarkSpiro) and a handheld nebulizer (DeVilbiss 45). The primary outcomes will be cough threshold measures (e.g., C2 and C5), defined as the citric acid concentration that elicits two or five coughs.
Participants will complete testing sessions using both delivery methods under controlled conditions. Findings from this proof-of-concept study will inform future research aimed at expanding access to objective cough assessment in clinical and community settings.
- Conditions
- Cough Reflex Sensitivity
- Being tested
- Cosmed QuarkSpiro Dosimeter-Controlled Nebulizer, DeVilbiss 45 Handheld Nebulizer
- Keywords
- cough challenge testing, cough reflex sensitivity testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmed QuarkSpiro Dosimeter-Controlled NebulizerDevice
Laboratory spirometry system equipped with a dosimeter-controlled nebulizer used to deliver standardized aerosolized citric acid during cough challenge testing.
DeVilbiss 45 Handheld NebulizerDevice
Commercial handheld nebulizer used to deliver aerosolized citric acid during cough challenge testing.
| Study group | Role | What they receive |
|---|---|---|
| Dosimeter-Controlled Cough Reflex Sensitivity Testing | Active comparator | Participants will undergo cough reflex sensitivity testing using a dosimeter-controlled nebulizer system (Cosmed QuarkSpiro) to deliver aerosolized citric acid. Receives: Device: Cosmed QuarkSpiro Dosimeter-Controlled Nebulizer |
| Handheld Nebulizer Cough Reflex Sensitivity Testing | Experimental | Participants will undergo cough reflex sensitivity testing using a handheld nebulizer (DeVilbiss 45) to deliver aerosolized citric acid. Receives: Device: DeVilbiss 45 Handheld Nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reliability of the concentration of citric acid that elicits two or more coughs (C2)
The test-retest reliability (Intraclass correlation coefficient) of the citric acid concentration required to elicit two coughs during cough challenge testing will be evaluated and compared for each testing method.
Measured: Cough sensitivity testing to determine cough thresholds (C2) will be performed at each of four weekly study visits, with visits occurring every 7 days across a 4-week study period.
Test-retest reliability of the concentration of citric acid that elicits five or more coughs (C5)
The test-retest reliability (Intraclass correlation coefficient) of the citric acid concentration required to elicit five coughs during cough challenge testing will be evaluated and compared for each testing method.
Measured: Cough sensitivity testing to determine cough thresholds (C5) will be performed at each of four weekly study visits, with visits occurring every 7 days across a 4-week study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start15 Jul 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cough Reflex SensitivityStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Healthy adult participants will complete cough sensitivity testing using two aerosol delivery systems.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531901
- Sponsor's protocol ID
- IRB-FY2026-31
- Other IDs
- 2P20GM130418-06
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data supporting the results reported in publications will be available upon reasonable request to the Principle Investigator following publication of study findings.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid
- ClinicalTrials.gov ID
- NCT07531901
- Acronym / sponsor ID
- IRB-FY2026-31
- Conditions
- Cough Reflex Sensitivity
- Keywords
- cough challenge testing, cough reflex sensitivity testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 15 Apr 2026 (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.
Objective cough reflex sensitivity testing is typically restricted to specialized research laboratories due to reliance on expensive dosimeter-controlled aerosol delivery systems. This study evaluates the feasibility and reliability of a low-cost alternative method using a handheld nebulizer for citric acid cough challenge testing. Healthy adult participants will complete cough reflex sensitivity testing using both a standard dosimeter-controlled nebulizer system (Cosmed QuarkSpiro) and a handheld nebulizer (DeVilbiss 45). The study will compare cough threshold outcomes between methods to determine whether handheld nebulizer-based testing produces comparable and reproducible measurements.
Detailed description
Cough reflex sensitivity testing is widely used in respiratory research to quantify airway sensory responsiveness. Traditional testing protocols use dosimeter-controlled nebulizer systems to deliver precise concentrations of aerosolized tussive agents such as citric acid. However, these systems are costly and require specialized laboratory infrastructure, limiting access to objective cough testing in outpatient and community-based settings.
This study investigates the feasibility and reliability of using a commercially available handheld nebulizer as a low-cost alternative for cough reflex sensitivity testing. Healthy adult volunteers will undergo standardized cough challenge testing using citric acid delivered through two aerosol delivery systems: a laboratory dosimeter-controlled nebulizer (Cosmed QuarkSpiro) and a handheld nebulizer (DeVilbiss 45). The primary outcomes will be cough threshold measures (e.g., C2 and C5), defined as the citric acid concentration that elicits two or five coughs.
Participants will complete testing sessions using both delivery methods under controlled conditions. Findings from this proof-of-concept study will inform future research aimed at expanding access to objective cough assessment in clinical and community settings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Healthy adult participants will complete cough sensitivity testing using two aerosol delivery systems.
| Arm | Type | Receives |
|---|---|---|
| Dosimeter-Controlled Cough Reflex Sensitivity Testing | Active comparator | Device: Cosmed QuarkSpiro Dosimeter-Controlled NebulizerParticipants will undergo cough reflex sensitivity testing using a dosimeter-controlled nebulizer system (Cosmed QuarkSpiro) to deliver aerosolized citric acid. |
| Handheld Nebulizer Cough Reflex Sensitivity Testing | Experimental | Device: DeVilbiss 45 Handheld NebulizerParticipants will undergo cough reflex sensitivity testing using a handheld nebulizer (DeVilbiss 45) to deliver aerosolized citric acid. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults at least 18 years of age
- Consent to audio/video recording of the research sessions for research purposes
- Spirometry testing results obtained by study team on same day of first testing session with FEV1/FVC ratio and FEV1 percent predicted values of at least 0.70
Key exclusion criteria (9 listed)
- Pregnant or trying to become pregnant (if capable of becoming pregnant- a urine pregnancy test will be provided onsite and a negative result must be obtained prior to the first testing session)
- Smoking of any substance in the last six months
- Diagnosed or suspected pulmonary disease (e.g., asthma, COPD)
- History of chronic cough
- History of head or neck cancer
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 |
|---|---|---|
| Cosmed QuarkSpiro Dosimeter-Controlled NebulizerLaboratory spirometry system equipped with a dosimeter-controlled nebulizer used to deliver standardized aerosolized citric acid during cough challenge testing. | Device | Dosimeter-Controlled Cough Reflex Sensitivity Testing |
| DeVilbiss 45 Handheld NebulizerCommercial handheld nebulizer used to deliver aerosolized citric acid during cough challenge testing. | Device | Handheld Nebulizer Cough Reflex Sensitivity Testing |
Primary outcome
Test-retest reliability of the concentration of citric acid that elicits two or more coughs (C2)
Time frame: Cough sensitivity testing to determine cough thresholds (C2) will be performed at each of four weekly study visits, with visits occurring every 7 days across a 4-week study period.
The test-retest reliability (Intraclass correlation coefficient) of the citric acid concentration required to elicit two coughs during cough challenge testing will be evaluated and compared for each testing method.
Test-retest reliability of the concentration of citric acid that elicits five or more coughs (C5)
Time frame: Cough sensitivity testing to determine cough thresholds (C5) will be performed at each of four weekly study visits, with visits occurring every 7 days across a 4-week study period.
The test-retest reliability (Intraclass correlation coefficient) of the citric acid concentration required to elicit five coughs during cough challenge testing will be evaluated and compared for each testing method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data supporting the results reported in publications will be available upon reasonable request to the Principle Investigator following publication of study findings.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DeVilbiss 45 Handheld Nebulizer in people with Cough Reflex Sensitivity, run by University of Montana at 1 site in United States.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane E Salois, PhD (406-243-2138, jane.salois@umontana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest reliability of the concentration of citric acid that elicits two or more coughs (C2) (time frame: Cough sensitivity testing to determine cough thresholds (C2) will be performed at each of four weekly study visits, with visits occurring every 7 days across a 4-week study period.). The study lists 2 primary outcomes in all. 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 20 Jul 2026.