Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

• ClinicalTrials.gov Identifier: NCT02203162
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Results First Posted: May 4, 2016
• Last Update Posted: June 4, 2018
• Sponsor: Montefiore Medical Center
• Information provided by (Responsible Party): Peter Dicpinigaitis, Montefiore Medical Center

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Cough
• Intervention: Device: electronic cigarette exposure
• Enrollment: 30

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Electronic Cigarette Exposure
Arm/Group Description	30 healthy subjects-adult nonsmokers
Period Title: Overall Study
Started	30
Completed	30
Not Completed	0

Baseline Characteristics

Arm/Group Title		Subjects
Arm/Group Description		all subjects underwent cough challenge testing at baseline and after e-cig exposure
Overall Number of Baseline Participants		30
Baseline Analysis Population Description		adult nonsmokers
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	30 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	30 100.0%
	>=65 years	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	30 participants
	Female	15 50.0%
	Male	15 50.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	30 participants
		30
cough reflex sensitivity; Mean (Standard Deviation); Unit of measure: Log C5
	Number Analyzed	30 participants
		0.5 (0.09)

Outcome Measures

1. Primary Outcome

Title	Change in Cough Reflex Sensitivity (Log C5)
Description	Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.
Time Frame	Baseline, 15 minutes, and 24 hours post-exposure to e-cig.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Electronic Cigarette Exposure
Arm/Group Description:	30 subjects-healthy adult nonsmokers
Overall Number of Participants Analyzed	30
Mean (95% Confidence Interval); Unit of Measure: log C5
change after 15 min	-0.29; (-0.43 to -0.15)
change after 24 hr	0.24; (0.10 to 0.38)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Subjects
Arm/Group Description	30 subjects-adult nonsmokers
All-Cause Mortality
	Subjects
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Subjects
	Affected / at Risk (%)
Total	0/30 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Subjects
	Affected / at Risk (%)
Total	0/30 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Peter Dicpinigaitis, MD
• Organization: Montefiore Medical Center
• Phone: 718-904-2676
• EMail: pdicpini@montefiore.org

Publications of Results:

Dicpinigaitis PV, Lee Chang A, Dicpinigaitis AJ, Negassa A. Effect of e-Cigarette Use on Cough Reflex Sensitivity. Chest. 2016 Jan;149(1):161-5. doi: 10.1378/chest.15-0817. Epub 2016 Jan 6.

• Responsible Party: Peter Dicpinigaitis, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT02203162
• Other Study ID Numbers: MMC-IRB-2014-3288
• First Submitted: July 25, 2014
• First Posted: July 29, 2014
• Results First Submitted: January 22, 2016
• Results First Posted: May 4, 2016
• Last Update Posted: June 4, 2018