Acute Health Effects of Passive Vape Among COPD Patients

Electronic Cigarette Use Clinical Trial

— PASVAP  

Official title:

Acute Health Effects of Passive Exposure to Particles From Electronic Cigarettes - a Randomized Controlled Double-blinded Cross-over Trial Among COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316234
• Other study ID #: 1711000
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: March 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. Little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible.

The aim of the present study was to investigate local and systemic effects of short-term passive exposure to vape from e-cigarettes among patients with mild or moderate chronic obstructive pulmonary disease COPD in a randomized controlled double-blinded cross-over study.

Description:

Introduction: The use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. Little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible.

Aim: to investigate local and systemic effects of short-term passive exposure to vape from e-cigarettes among patients with mild or moderate chronic obstructive pulmonary disease (COPD).

Design: In a randomised double-blinded cross-over study non-smoking COPD patients were exposed for four hours at two different exposure conditions separated by 14 days; A) clean filtered air and B) passive vaping under controlled environmental conditions.

Measurements: TSI P-TRAK Ultrafine Particle Counter was used for particle counts. Health effects, including lung function (FEV1/FVC) and fraction of exhaled nitric oxide (FeNO) were evaluated in relation to local and systemic effects prior to, right after and 24 h. after exposure.

Analysis: Mixed methods approach taking both time and exposure into account.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Never smoker or ex-smokers = 6 months

• Aged 18+

• A known diagnosis of COPD (FEV1/FVC < lower limit of normal, app. 70%)

• MRC = 2 or CAT score = 10

Exclusion Criteria:

• Exposure to smoking more than 30 min./day

• Treatment with inhaled or oral corticosteroids

• Known hypersensitivity to constituents in e-cigarettes

• Any other disease that could influence the study parameters

• Conditions that prevent safe access to the climate chambers (such as claustrophobia)

• Perennial rhinitis

• Deformed nasal airways

• Not being able to change from long-acting medication to short-acting medication

Related Conditions & MeSH terms

• Electronic Cigarette Use
• Lung Function
• Second Hand Smoke

Intervention

Other:
• Passive vape
On days with passive vape, 2-3 vapers in an adjacent chamber were vaping by turn, and vape was passed on to the exposure chamber continuously .

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus	Central Region Denmark

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Particles in Exhaled Air (Surfactant Protein A & Albumin)	PExA: Subjects performed repeated breath maneuvers allowing for airway closure and re-opening, and exhaled particles were optically counted and collected on a membrane using the (novel) PExA® instrument set-up.	At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Secondary	Change in Lung Function (FEV1 & FVC)	Spirometry	At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Secondary	Change in Fractional exhaled nitric oxide (FENO)	NIOX system; Aerocrine AB, Sweden	At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Secondary	Change in Blood samples	IL-8, Nightingale analyses for biomarkers	At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Secondary	Change in nasal volume (using Acoustic rhinometry)	Is used to assess the nasal cross sectional area and volume. The left and right nasal cavity were studied alternatively until three reproducible measurements were obtained. The minimum cross sectional cavity area was calculated from the means of the measurements. By integration of the area-distance curve, the sum of the volume 2 to 4 (vol2-4) from the nostril was determined on both sides.	At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Secondary	Change in Symptom questionnaire	In the exposure chamber participants were asked to fill out a symptom questionnaire every 30 min. regarding their well-being and experienced symptoms in eyes, nose and mouth.	Every 30 min during 4 hours of exposure.
Secondary	Change in biomarkers in Saliva Sample	An oral svap from Salivette was placed in the mouth of the participant to collect saliva by gently chewing the swab for one minute. Afterwards the saturated swab was removed to the suspended insert and closed firmly with a lid. Then the sample was transferred to a freezer and stored for -80 C until further analysis. The sample will be analyzed for biomarkers (amylase, cortisol, substance P, lysozyme and secretory IgA.)	At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)