Acute Health Effects of Passive Vape Among COPD Patients

NCT04316234 | Completed DMC

• 1 other identifier: 1711000
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Electronic Cigarette Use; Second Hand Smoke; Lung Function

Keywords

Electronic cigarettes; Secondhand vape; Health effects; Lung function; Biomarkers; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Lung Function (FEV1 & FVC)

  At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)

• Change in Fractional exhaled nitric oxide (FENO)

  At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)

• Change in Blood samples

  At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)

• Change in nasal volume (using Acoustic rhinometry)

  At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)

• Change in Symptom questionnaire

  Every 30 min during 4 hours of exposure.

Study Arms (2)

A. Clean Air

NO INTERVENTION

Clean air - no vaping was done.

B. Passive vaping

EXPERIMENTAL

E-cigarette users were present in an adjacent chamber during both exposures, but only in situation B they were vaping and the vape-polluted air was passed on to the exposure chamber.

Other: Passive vape

Interventions

Passive vape OTHER

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 .

B. Passive vaping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University

Aarhus, Central Region Denmark, 8000, Denmark

Location

MeSH Terms

Conditions

Vaping; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Smoking; Behavior; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karin R Laursen, MSc

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Vaping was done in another chamber and thereby led into the exposure chamber, so it could not be observed. On days with clean air, vapers were chewing nicotine gum instead of vaping.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Doctor

Model Details: A randomised double-blinded cross-over study

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: March 20, 2020
• Study Start: March 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)