Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid

ConditionCough Reflex Sensitivity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-89

SponsorUniversity of Montana

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

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.
DeVilbiss 45 Handheld Nebulizer
Device
Commercial handheld nebulizer used to deliver aerosolized citric acid during cough challenge testing.

Treatment groups

10 Participants

are divided into 2 treatment groups

Group A: Dosimeter-Controlled Cough Reflex Sensitivity TestingActive comparator 1 intervention

Group B: Handheld Nebulizer Cough Reflex Sensitivity TestingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

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.

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.

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.

Sponsors and contacts

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University of Montana

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator

Source ClinicalTrials.gov

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