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Health Effects of Secondhand Smoke Exposure in Outdoor Smoking Areas in Patients With COPD and Asthma ( TackSHSWP5 )

NCT03074734 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-07-03

Study results available
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Summary

Within the TackSHS project (H2020 project grant agreement No 681040), we will conduct a clinical research study, aiming at: i) to measure respiratory health effects when exposed to secondhand smoke (SHS) in patients with asthma and Chronic Obstructive Pulmonary Disease (COPD); ii) to investigate exposure levels to SHS in smoking areas provided by bars, casinos, bingo halls, etc. The study will involve 60 patients (volunteers) in three European countries: Czech Republic, Ireland, and Spain, recruiting 20 patients in each participating country (10 COPD and 10 asthma patients).

Conditions

Interventions

OTHER

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.

Sponsors & Collaborators

  • TobaccoFree Research Institute

    collaborator OTHER

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    collaborator OTHER

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    collaborator OTHER

  • Institut Català d'Oncologia

    lead OTHER

Principal Investigators

  • Luke Clancy, MB, MD, PhD · TobaccoFree Research Institute Ireland (TFRI)

  • Sheila Keogan, RGN, MPhil · TobaccoFree Research Institute Ireland (TFRI)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-05-31
Completion
2019-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03074734 on ClinicalTrials.gov