Trial Outcomes & Findings for Health Effects of Secondhand Smoke Exposure in Outdoor Smoking Areas in Patients With COPD and Asthma ( TackSHSWP5 ) (NCT NCT03074734)

NCT ID: NCT03074734

Last Updated: 2023-07-03

Results Overview

Respiratory rate during non exposure and exposure to secondhand smoke: change from baseline respiratory symptoms

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 24hours to include during non exposure and exposure to SHS
• Results posted on: 2023-07-03

Participant Flow

There was no wash out or run in period. The participants attended on the day of the intervention for collection of baseline data and fitting of personal devices. There were no exclusions.

Participant milestones

Measure	Exposure to Secondhand Tobacco Smoke Exposure to secondhand tobacco smoke in outside smoking areas Exposure to secondhand tobacco smoke: The intervention is exposure to secondhand smoke of COPD and asthma patients in outside smoking areas (no specific drugs or devices are tested in this study). Study subjects will be asked to spend at least 15 minutes in the outdoor smoking area, a preferable time of 30-60 mins. During the exposure period (15-60 min) subjects´ respiratory rates will be recorded using RESpeck device, as well as the air quality which will be monitored using AirSpeck device.
Overall Study STARTED	60
Overall Study Recruitment	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Exposure to Secondhand Tobacco Smoke n=60 Participants Exposure to secondhand tobacco smoke in outside smoking areas Exposure to secondhand tobacco smoke: The intervention is exposure to secondhand smoke of COPD and asthma patients in outside smoking areas (no specific drugs or devices are tested in this study). Study subjects will be asked to spend at least 15 minutes in the outdoor smoking area, a preferable time of 30-60 mins. During the exposure period (15-60 min) subjects´ respiratory rates will be recorded using RESpeck device, as well as the air quality which will be monitored using AirSpeck device.
Age, Categorical <=18 years	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=60 Participants
Age, Categorical >=65 years	14 Participants n=60 Participants
Age, Continuous	55.1 Years STANDARD_DEVIATION 17.1 • n=60 Participants
Sex: Female, Male Female	35 Participants n=60 Participants
Sex: Female, Male Male	25 Participants n=60 Participants
Region of Enrollment Ireland	10 participants n=60 Participants
Region of Enrollment Czechia	30 participants n=60 Participants
Region of Enrollment Spain	20 participants n=60 Participants
Respiratory Rate (breath rate pre-exposure)	21.66 breaths per min STANDARD_DEVIATION 3.08 • n=60 Participants
PM 2.5 exposure levels	101.45 µg/m3 STANDARD_DEVIATION 103.36 • n=60 Participants

PRIMARY outcome

Timeframe: 24hours to include during non exposure and exposure to SHS

Respiratory rate during non exposure and exposure to secondhand smoke: change from baseline respiratory symptoms

Outcome measures

Measure	Exposure to Secondhand Tobacco Smoke n=60 Participants Exposure to secondhand tobacco smoke in outside smoking areas Exposure to secondhand tobacco smoke: The intervention is exposure to secondhand smoke of COPD and asthma patients in outside smoking areas (no specific drugs or devices are tested in this study). Study subjects will be asked to spend at least 15 minutes in the outdoor smoking area, a preferable time of 30-60 mins. During the exposure period (15-60 min) subjects´ respiratory rates will be recorded using RESpeck device, as well as the air quality which will be monitored using AirSpeck device.
Respiratory Rate During Non Exposure to SHS	21.66 BR/M breathing rate per min Standard Deviation 3.08
Respiratory Rate During exposure to SHS	21.57 BR/M breathing rate per min Standard Deviation 2.84

SECONDARY outcome

Timeframe: 1) At homes - 24 hours, during the study period; 2) in outside smoking areas - 15-60 minutes during the intervention

Levels of exposure to secondhand smoke both, at home (monitoring the exposure to SHS and in outside smoking areas (15-60 minutes, measures performed using AirSpeck devices).

Outcome measures

Measure	Exposure to Secondhand Tobacco Smoke n=60 Participants Exposure to secondhand tobacco smoke in outside smoking areas Exposure to secondhand tobacco smoke: The intervention is exposure to secondhand smoke of COPD and asthma patients in outside smoking areas (no specific drugs or devices are tested in this study). Study subjects will be asked to spend at least 15 minutes in the outdoor smoking area, a preferable time of 30-60 mins. During the exposure period (15-60 min) subjects´ respiratory rates will be recorded using RESpeck device, as well as the air quality which will be monitored using AirSpeck device.
Secondhand Smoke Exposure Levels Mean PM 2.5 in SHS area	101.45 μg/ m3 Standard Deviation 103.36
Secondhand Smoke Exposure Levels Mean PM 2.5 in non SHS area	233.59 μg/ m3 Standard Deviation 101.88

SECONDARY outcome

Timeframe: 24hours: pre during and post SHS exposure

Medication usage pre and post exposure to secondhand smoke: change from baseline respiratory symptoms within 24hrs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

All participants were asked to report any increased use of medication required post exposure to SHS area.

Outcome measures

Measure	Exposure to Secondhand Tobacco Smoke n=60 Participants Exposure to secondhand tobacco smoke in outside smoking areas Exposure to secondhand tobacco smoke: The intervention is exposure to secondhand smoke of COPD and asthma patients in outside smoking areas (no specific drugs or devices are tested in this study). Study subjects will be asked to spend at least 15 minutes in the outdoor smoking area, a preferable time of 30-60 mins. During the exposure period (15-60 min) subjects´ respiratory rates will be recorded using RESpeck device, as well as the air quality which will be monitored using AirSpeck device.
Medication Usage Participants reporting increased medication use	0 Participants
Medication Usage Participants reporting unscheduled Dr visit	0 Participants

Adverse Events

Exposure to Secondhand Tobacco Smoke

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Luke Clancy

TobaccoFree Research Institute Ireland

Phone: +353868364337

Email: lclancy@tri.ie

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place