10 Participants NeededMy employer runs this trial

Handheld Nebulizers for Cough Sensitivity Testing

JE
LJ
Overseen ByLaurie J Slovarp, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Montana
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 or older who have normal lung function and agree to be audio/video recorded during the study sessions.

Inclusion Criteria

I am a healthy adult who is at least 18 years old.
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
Consent to audio/video recording of the research sessions for research purposes

Exclusion Criteria

I have a history of chronic cough.
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
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Testing

Participants undergo cough reflex sensitivity testing using both dosimeter-controlled and handheld nebulizer systems

4 weeks
4 visits (in-person), occurring every 7 days

Follow-up

Participants are monitored for safety and effectiveness after testing

2 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two devices—a standard dosimeter-controlled nebulizer (Cosmed QuarkSpiro) and a handheld nebulizer (DeVilbiss 45)—to see if the handheld device can reliably measure cough sensitivity using citric acid, like the more expensive system.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Handheld Nebulizer Cough Reflex Sensitivity TestingExperimental Treatment1 Intervention
Group II: Dosimeter-Controlled Cough Reflex Sensitivity TestingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Montana

Lead Sponsor

Trials
29
Recruited
4,700+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+