NCT05260827

Brief Summary

This is a human randomized controlled cross-over study where we investigate the effects of heated tobacco products (HTP) on lung function and on assessing volatile organic compounds in exhaled air.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

October 8, 2021

Last Update Submit

March 7, 2024

Conditions

Lung Inflammation

Keywords

lung functionvolatile organic compoundsexhaled airHeated tobacco products

Outcome Measures

Primary Outcomes (4)

  • Volatile organic compounds in exhaled air, nanogram/l (please see study description for specification of VOC)

    in exhaled air

    preexposure

  • Volatile organic compounds in exhaled air, nanogram/l (please see study description for specification of VOC)

    in exhaled air

    10 minutes

  • Volatile organic compounds in exhaled air, nanogram/l (please see study description for specification of VOC)

    in exhaled air

    30 minutes

  • Volatile organic compounds in exhaled air, nanogram/l (please see study description for specification of VOC)

    in exhaled air

    120 minutes

Study Arms (2)

Heated tobacco product

EXPERIMENTAL

30 puffs of heated tobacco product IQOS

Other: Heated tobacco product

Sham

EXPERIMENTAL

sham heated tobacco product

Other: Heated tobacco product

Interventions

Heated tobacco productOTHER

Sham heated tobacco product

Heated tobacco productSham

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, free from medication

You may not qualify if:

  • Any form of cardiovascular disease
  • Any form of pulmonary disease like asthma or COPD
  • Any form of systemic or chronic disorder like rheumatologic or metabolic diseases. - Symptoms of infection or inflammation within 4 weeks of the study
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institutionen för kliniska vetenskaper, Danderyds sjukhus

Danderyd, Stockholm County, 18288, Sweden

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomised controlled cross-over study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

October 8, 2021

First Posted

March 2, 2022

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

February 1, 2023

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)