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

NCT03074734 | Completed Results DMC

• 1 other identifier: TackSHS WP5
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

COPD; Asthma; Second Hand Tobacco Smoke

Keywords

secondhand smoke; passive smoking; respiratory diseases; COPD; asthma; SHS health effect

Outcome Measures

Primary Outcomes (1)

• Respiratory Rate

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

  24hours to include during non exposure and exposure to SHS

Secondary Outcomes (3)

• Secondhand Smoke Exposure Levels

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

• Medication Usage

  24hours: pre during and post SHS exposure

• Medication Usage

  24 hours

Study Arms (1)

Exposure to secondhand tobacco smoke

OTHER

Exposure to secondhand tobacco smoke in outside smoking areas

Other: Exposure to secondhand tobacco smoke

Interventions

Exposure to secondhand tobacco smoke OTHER

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.

Exposure to secondhand tobacco smoke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed Dr Diagnosed COPD patients
• Current or ex-smokers
• Fully ambulatory
• Frequent visits to smoking areas\*
• Between 50 and 70 years old
• Confirmed Dr Diagnosed Asthmatic patients
• Fully ambulatory
• Frequent visits to smoking areas
• Over 18 years old

You may not qualify if:

• Under 18 years old
• On oxygen therapy
• Never smokers in COPD patient group
• Undergoing treatment for acute exacerbations
• Pregnant women
• Irish law has defined an outdoor smoking area as: a place or premises, or part of a place or premises that, is wholly uncovered by any roof, fixed or mobile. An out door place or premises that is covered by a roof, so long as not more than 50% of the perimeter (outside) is covered by a wall, windows, gate or similar.

Sponsors & Collaborators

• Institut Català d'Oncologia: lead
• TobaccoFree Research Institute: collaborator
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator
• Mario Negri Institute for Pharmacological Research: collaborator
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator

Related Links

• TackSHS Project at CORDIS

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Professor Luke Clancy
• Organization: TobaccoFree Research Institute Ireland

lclancy@tri.ie

+353868364337

Study Officials

• Luke Clancy, MB, MD, PhD

  TobaccoFree Research Institute Ireland (TFRI)

  PRINCIPAL INVESTIGATOR

• Sheila Keogan, RGN, MPhil

  TobaccoFree Research Institute Ireland (TFRI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: March 9, 2017
• Study Start: June 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share