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NCT Number: NCT07531901

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

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Montana

Missoula, Montana, 59812, United States

Location status: Recruiting

Location contact

Jane E Salois, PhD

CONTACT

[email protected]

406-243-2138

Jane E Salois, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jane E Salois, PhD

CONTACT

[email protected]

406-243-2138

Laurie J Slovarp, PhD

CONTACT

[email protected]

406-243-2107

Sponsors and collaborators

Lead sponsor

University of Montana

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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