Recruiting

Nebulizer Testing

Sponsor:

University of Montana

Code:

NCT07531901

Conditions

Cough Reflex Sensitivity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Cosmed QuarkSpiro Dosimeter-Controlled Nebulizer

DeVilbiss 45 Handheld Nebulizer

Study Details

Brief summary:

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.

Conditions

Cough Reflex Sensitivity

Study ID

NCT07531901

Start date

Jul 15, 2026

Status verified date

Mar, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • History of dysphagia (swallowing difficulty)
  • Current complaint of a voice problem
  • Current upper respiratory infection

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Cosmed QuarkSpiro Dosimeter-Controlled Nebulizer

Laboratory spirometry system equipped with a dosimeter-controlled nebulizer used to deliver standardized aerosolized citric acid during cough challenge testing.

DeVilbiss 45 Handheld Nebulizer

Commercial handheld nebulizer used to deliver aerosolized citric acid during cough challenge testing.

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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Jane E Salois, PhD

406-243-2138jane.salois@umontana.edu

Laurie J Slovarp, PhD

406-243-2107laurie.slovarp@umontana.edu

Locations

University of Montana

Recruiting

Missoula, Montana, United States, 59812

Contacts

Jane E Salois, PhD

406-243-2138jane.salois@umontana.edu

Principal Investigator:

Jane E Salois, PhD

More Information

Sponsor

University of Montana

Last update posted

Jul 20, 2026

Last verified

Mar, 2026

Keywords

  • cough challenge testing
  • cough reflex sensitivity testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Montana on 2026-07-20.