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Trial record 2 of 762 for:    Tobacco Smoke

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

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ClinicalTrials.gov Identifier: NCT03074734
Recruitment Status : Active, not recruiting
First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Collaborators:
TobaccoFree Research Institute
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Mario Negri Institute for Pharmacological Research
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Information provided by (Responsible Party):
Institut Català d'Oncologia

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: Hungary, Ireland, and Spain, recruiting 20 patients in each participating country (10 COPD and 10 asthma patients).

Condition or disease Intervention/treatment Phase
COPD Asthma Second Hand Tobacco Smoke Other: Exposure to secondhand tobacco smoke Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exposure to Secondhand Smoke in Exempted Areas/Outside Areas and Acute Health Effects in Patients With Chronic Lung Disease
Actual Study Start Date : June 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Smoking

Arm Intervention/treatment
Exposure to secondhand tobacco smoke
Exposure to secondhand tobacco smoke in outside smoking areas
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/leosound device, as well as the air quality which will be monitored using AirSpeck/SidePak device.




Primary Outcome Measures :
  1. Respiratory symptoms [ Time Frame: 7 days: 2-4 days before exposure as pre measurement and 2-4 days period after exposure as a post measurement ]
    Respiratory symptoms pre and post exposure to secondhand smoke: change from baseline respiratory symptoms (1st visit) within a week


Secondary Outcome Measures :
  1. Secondhand smoke exposure levels [ Time Frame: 1) At homes - 7 days, 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 via diary cards) and in outside smoking areas (15-60 minutes, measures performed using SidePak/AirSpeck devices)

  2. Medication usage [ Time Frame: 7 days: 2-4 days before exposure as pre measurement and 2-4 days period after exposure as a post measurement ]
    Medication usage pre and post exposure to secondhand smoke: change from baseline respiratory symptoms (1st visit) within a week



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074734


Sponsors and Collaborators
Institut Català d'Oncologia
TobaccoFree Research Institute
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Mario Negri Institute for Pharmacological Research
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Luke Clancy, MB, MD, PhD TobaccoFree Research Institute Ireland (TFRI)
Principal Investigator: Sheila Keogan, RGN, MPhil TobaccoFree Research Institute Ireland (TFRI)

Additional Information:
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Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT03074734     History of Changes
Other Study ID Numbers: TackSHS WP5
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Català d'Oncologia:
secondhand smoke
passive smoking
respiratory diseases
COPD
asthma
SHS health effect

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases