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| ID | Type | Description | Link |
|---|---|---|---|
| 2P20GM130418-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmed QuarkSpiro Dosimeter-Controlled Nebulizer | Device | Laboratory spirometry system equipped with a dosimeter-controlled nebulizer used to deliver standardized aerosolized citric acid during cough challenge testing. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane E Salois, PhD | Contact | 406-243-2138 | jane.salois@umontana.edu | |
| Laurie J Slovarp, PhD | Contact | 406-243-2107 | laurie.slovarp@umontana.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Montana | Recruiting | Missoula | Montana | 59812 | United States |
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.
IPD and supporting information will be available as soon as one month after data are published and available for up to three years after publication.
Data will be shared with qualified investigators who provide a methodologically sound proposal and documentation of appropriate institutional approvals, where required. Data will be shared in a de-identified format consistent with institutional policies and applicable privacy protections. Due to the small sample size, additional safeguards may be implemented to prevent potential participant re-identification.
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Healthy adult participants will complete cough sensitivity testing using two aerosol delivery systems.
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| DeVilbiss 45 Handheld Nebulizer | Device | Commercial handheld nebulizer used to deliver aerosolized citric acid during cough challenge testing. |
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