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

Conditions

• Cough Reflex Sensitivity

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jun 5, 2026

Status verified

Mar 2026

Primary completion

Feb 1, 2027

Completion

Feb 28, 2027

Study Design

Enrollment

10 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: Dosimeter-Controlled Cough Reflex Sensitivity Testing
  Participants will undergo cough reflex sensitivity testing using a dosimeter-controlled nebulizer system (Cosmed QuarkSpiro) to deliver aerosolized citric acid.
• Experimental: Handheld Nebulizer Cough Reflex Sensitivity Testing
  Participants will undergo cough reflex sensitivity testing using a handheld nebulizer (DeVilbiss 45) to deliver aerosolized citric acid.

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. ]

Central Contacts

• Jane E Salois, PhD
  406-243-2138
  [email protected]
• Laurie J Slovarp, PhD
  406-243-2107
  [email protected]

Locations (1)

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