COPDTackSHSWP5NCT03074734
Health Effects of Secondhand Smoke Exposure in Outdoor Smoking Areas in Patients With COPD and Asthma ( TackSHSWP5 )
A study testing Exposure to secondhand tobacco smoke in people with COPD and Asthma, run by Institut Català d'Oncologia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Asthma, Second Hand Tobacco Smoke
- What is being tested?
- Exposure to secondhand tobacco smoke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Fully ambulatory
- Frequent visits to smoking areas
- Over 18 years old
Who cannot join
- 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.
About this study
Official title: Exposure to Secondhand Smoke in Exempted Areas/Outside Areas and Acute Health Effects in Patients With Chronic Lung Disease
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).
Read the detailed description
The current study is a part of the TackSHS project and will be conducted in three selected European countries, coordinated by Prof Luke Clancy, Director General of TobaccoFree Research Institute (Dublin, Ireland).
Background: Respiratory disease causes an important worldwide health burden. It was estimated that in 2020, of 68 million deaths worldwide, 11.9 million will be caused by lung diseases, 4.7 by COPD, 2.5 by pneumonia, 2.4 by TB and 2.3 million by lung cancer. Over the past two decades, scientific evidence has accumulated linking secondhand tobacco smoke (SHS) exposure to adverse health outcomes, including respiratory outcomes in children and adults, acute cardiovascular effects, and lung cancer. However, there is scarce knowledge about health effects of SHS on respiratory disease patients. TackSHS is a new research project funded by the European Commission (EC) within the Horizon 2020 programme (Grant Agreement: 681040). Within the TackSHS Project, WorkPackage 5 is aimed to broaden knowledge and improve understanding of (immediate) effects of SHS to respiratory health.
The study objectives are to:
- measure respiratory health effects when exposed to SHS in: patients with asthma and COPD
- investigate exposure levels to Second Hand Smoke (SHS) in smoking areas provided by bars, casinos, bingo halls, etc.
Study Design Population: The study population will consist of 30 Asthmatic and 30 COPD subjects to be recruited through the European Lung Foundation (ELF) in three EU countries (20 subjects in each country), leading to a total sample of 60 participants.
Study location: Czech Republic, Ireland, Spain
Study description
To achieve the above mentioned objectives the described below study was designed.
Each patient will visit the centre on 2 occasions. During the first visit the study will be explained to the participants, both in written (information sheet) and oral forms, the recruitment questionnaire will be filled to ascertain personal smoking status, other sources of exposure, average weekly exposure in hospitality premises, and experience of respiratory symptoms; in addition, CO reading and spirometry will be performed by experienced nurse. During this session, patients will be also trained of fitting and use of necessary devices: Respeck / AirSpeck. Diary cards will be demonstrated and explained to the patients. This first visit will be scheduled during the day prior to exposure.
After the first visit, all participants will be asked to fill in daily diary cards recording morning and evening peak flow results, medication consumed, any occurring symptoms (cough, wheeze), doctor or hospital visits, exposure to SHS and number of cigarettes smoked (if any). The participants will be also asked to note when the exposure to outside SHS occurred as well as peak flow results pre and post exposure.
All the patients will be trained in the use of monitoring equipment, which will measure their exposure to pollutants including SHS as well as measuring the effects on their health. Air pollution will be measured through the use of a cutting-edge, small portable instrument that can continuously and rapidly record changes in the air. Respiratory function will be measured by Spirometry and exhaled breath gases (e.g. Carbon Monoxide). A small sensor attached to each participant's chest (RESpeck) will measure and record respiratory rate and or wheeze. This will not cause any undue discomfort or inconvenience to participants.
Intervention (Exposure) At least one outing to an outdoor smoking area should happen. The duration of time to be spent in the outdoor smoking area is to be a minimum of 15 minutes with a preferable time of 30-60 minutes. Diary card entries are to be done on day of exposure and will include description of premises visited number of smokers and or E-cigarette users present during exposure time as well as any use of medication required during the 24hour period.
At the second (post exposure) visit all data recorded by devices will be downloaded and checked and any diary card anomalies will be addressed and clarified with the patient. In addition, CO reading and spirometry will be repeated.
National Partners will be trained in the use of devices measuring exposure using AirSpeck and respiratory rate using RESpeck. Data will be transmitted to a secure server for analysis Data collection, analysis and report writing: this will be carried out by TFRI in collaboration with Project Partners and in consultation with Prof Rod Jones and Prof DK Arvind.
Primary endpoints:
- To monitor personal exposure to SHS in areas exempted from legislation in pubs, bars and casinos etc. using novel monitoring technologies
- To simultaneously monitor the respiratory effects as indicated by changes in respiratory rate and flow and activity levels
- To monitor peak flow rates recorded by patients using diary cards and peak flow meters.
Secondary endpoints:
- Medication usage
- Primary care and/or hospital visits
- CO monitoring pre and post study
- Spirometry results pre and post exposure
Ethical approval was sought from DIT Ethics Committee prior to beginning of the project. All documentation relating to the project was provided for ethical review. There are no perceived Ethical issues as patients will be fully informed and there will be no intervention other than monitoring. It was considered that requesting subjects to go into outside smoking areas might be a problem so only subjects who are already frequent visitors of such areas will be recruited.
Once eligibility has been determined patients will be given an appointment in a research center where they will receive an information leaflet. Once this has been read and any concerns of the participant addressed and explained, they will then be asked to provide written consent prior to their study enrolment. Consent will be obtained from all participants. Consent is on-going and participants can revoke consent at any stage of the project.
The safety of all research participants will be considered at all times, they will be seen in an insured medical practice. All personnel dealing with patients will be fully trained and insured.
All data will be stored on a secure server and will be de-identified. Data will be entered giving each participant a unique identifier code; neither their name, address, nor date of birth will be recorded in order to protect the confidentiality of the participant. Analysis will be carried out on a blinded dataset using SPSS.
All digitally recorded data will be downloaded from the device to a secure server. A Post Doc and or a Research assistant working with TFRI with advice from partners will further examine study data. Any anomalies found will be addressed and resolved from source data.
- Conditions
- COPD, Asthma, Second Hand Tobacco Smoke
- Being tested
- Exposure to secondhand tobacco smoke
- Keywords
- secondhand smoke, passive smoking, respiratory diseases, COPD, asthma, SHS health effect
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to secondhand tobacco smokeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposure to secondhand tobacco smoke | Other | Exposure to secondhand tobacco smoke in outside smoking areas Receives: Other: Exposure to secondhand tobacco smoke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate
Respiratory rate during non exposure and exposure to secondhand smoke: change from baseline respiratory symptoms
Measured: 24hours to include during non exposure and exposure to SHS
Secondary outcomes (3)
Secondhand Smoke Exposure Levels
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).
Measured: 1) At homes - 24 hours, during the study period; 2) in outside smoking areas - 15-60 minutes during the intervention
Medication Usage
Medication usage pre and post exposure to secondhand smoke: change from baseline respiratory symptoms within 24hrs.
Measured: 24hours: pre during and post SHS exposure
Medication Usage
All participants were asked to report any increased use of medication required post exposure to SHS area.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startJun 2016
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Luke Clancy, MB, MD, PhD, Principal investigator, TobaccoFree Research Institute Ireland (TFRI)Sheila Keogan, RGN, MPhil, Principal investigator, TobaccoFree Research Institute Ireland (TFRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074734
- Sponsor's protocol ID
- TackSHS WP5
- Acronym
- TackSHSWP5
- Status last verified
- Aug 2022
- First submitted
- 23 Jan 2017
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure to Secondhand Smoke in Exempted Areas/Outside Areas and Acute Health Effects in Patients With Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT03074734
- Acronym / sponsor ID
- TackSHSWP5 / TackSHS WP5
- Conditions
- COPD, Asthma, Second Hand Tobacco Smoke
- Keywords
- secondhand smoke, passive smoking, respiratory diseases, COPD, asthma, SHS health effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- 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
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The current study is a part of the TackSHS project and will be conducted in three selected European countries, coordinated by Prof Luke Clancy, Director General of TobaccoFree Research Institute (Dublin, Ireland).
Background: Respiratory disease causes an important worldwide health burden. It was estimated that in 2020, of 68 million deaths worldwide, 11.9 million will be caused by lung diseases, 4.7 by COPD, 2.5 by pneumonia, 2.4 by TB and 2.3 million by lung cancer. Over the past two decades, scientific evidence has accumulated linking secondhand tobacco smoke (SHS) exposure to adverse health outcomes, including respiratory outcomes in children and adults, acute cardiovascular effects, and lung cancer. However, there is scarce knowledge about health effects of SHS on respiratory disease patients. TackSHS is a new research project funded by the European Commission (EC) within the Horizon 2020 programme (Grant Agreement: 681040). Within the TackSHS Project, WorkPackage 5 is aimed to broaden knowledge and improve understanding of (immediate) effects of SHS to respiratory health.
The study objectives are to:
- measure respiratory health effects when exposed to SHS in: patients with asthma and COPD
- investigate exposure levels to Second Hand Smoke (SHS) in smoking areas provided by bars, casinos, bingo halls, etc.
Study Design Population: The study population will consist of 30 Asthmatic and 30 COPD subjects to be recruited through the European Lung Foundation (ELF) in three EU countries (20 subjects in each country), leading to a total sample of 60 participants.
Study location: Czech Republic, Ireland, Spain
Study description
To achieve the above mentioned objectives the described below study was designed.
Each patient will visit the centre on 2 occasions. During the first visit the study will be explained to the participants, both in written (information sheet) and oral forms, the recruitment questionnaire will be filled to ascertain personal smoking status, other sources of exposure, average weekly exposure in hospitality premises, and experience of respiratory symptoms; in addition, CO reading and spirometry will be performed by experienced nurse. During this session, patients will be also trained of fitting and use of necessary devices: Respeck / AirSpeck. Diary cards will be demonstrated and explained to the patients. This first visit will be scheduled during the day prior to exposure.
After the first visit, all participants will be asked to fill in daily diary cards recording morning and evening peak flow results, medication consumed, any occurring symptoms (cough, wheeze), doctor or hospital visits, exposure to SHS and number of cigarettes smoked (if any). The participants will be also asked to note when the exposure to outside SHS occurred as well as peak flow results pre and post exposure.
All the patients will be trained in the use of monitoring equipment, which will measure their exposure to pollutants including SHS as well as measuring the effects on their health. Air pollution will be measured through the use of a cutting-edge, small portable instrument that can continuously and rapidly record changes in the air. Respiratory function will be measured by Spirometry and exhaled breath gases (e.g. Carbon Monoxide). A small sensor attached to each participant's chest (RESpeck) will measure and record respiratory rate and or wheeze. This will not cause any undue discomfort or inconvenience to participants.
Intervention (Exposure) At least one outing to an outdoor smoking area should happen. The duration of time to be spent in the outdoor smoking area is to be a minimum of 15 minutes with a preferable time of 30-60 minutes. Diary card entries are to be done on day of exposure and will include description of premises visited number of smokers and or E-cigarette users present during exposure time as well as any use of medication required during the 24hour period.
At the second (post exposure) visit all data recorded by devices will be downloaded and checked and any diary card anomalies will be addressed and clarified with the patient. In addition, CO reading and spirometry will be repeated.
National Partners will be trained in the use of devices measuring exposure using AirSpeck and respiratory rate using RESpeck. Data will be transmitted to a secure server for analysis Data collection, analysis and report writing: this will be carried out by TFRI in collaboration with Project Partners and in consultation with Prof Rod Jones and Prof DK Arvind.
Primary endpoints:
- To monitor personal exposure to SHS in areas exempted from legislation in pubs, bars and casinos etc. using novel monitoring technologies
- To simultaneously monitor the respiratory effects as indicated by changes in respiratory rate and flow and activity levels
- To monitor peak flow rates recorded by patients using diary cards and peak flow meters.
Secondary endpoints:
- Medication usage
- Primary care and/or hospital visits
- CO monitoring pre and post study
- Spirometry results pre and post exposure
Ethical approval was sought from DIT Ethics Committee prior to beginning of the project. All documentation relating to the project was provided for ethical review. There are no perceived Ethical issues as patients will be fully informed and there will be no intervention other than monitoring. It was considered that requesting subjects to go into outside smoking areas might be a problem so only subjects who are already frequent visitors of such areas will be recruited.
Once eligibility has been determined patients will be given an appointment in a research center where they will receive an information leaflet. Once this has been read and any concerns of the participant addressed and explained, they will then be asked to provide written consent prior to their study enrolment. Consent will be obtained from all participants. Consent is on-going and participants can revoke consent at any stage of the project.
The safety of all research participants will be considered at all times, they will be seen in an insured medical practice. All personnel dealing with patients will be fully trained and insured.
All data will be stored on a secure server and will be de-identified. Data will be entered giving each participant a unique identifier code; neither their name, address, nor date of birth will be recorded in order to protect the confidentiality of the participant. Analysis will be carried out on a blinded dataset using SPSS.
All digitally recorded data will be downloaded from the device to a secure server. A Post Doc and or a Research assistant working with TFRI with advice from partners will further examine study data. Any anomalies found will be addressed and resolved from source data.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure to secondhand tobacco smoke | Other | Other: Exposure to secondhand tobacco smokeExposure to secondhand tobacco smoke in outside smoking areas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed Dr Diagnosed COPD patients
- Current or ex-smokers
- Fully ambulatory
- Frequent visits to smoking areas*
- Between 50 and 70 years old
Key exclusion criteria (6 listed)
- Under 18 years old
- On oxygen therapy
- Never smokers in COPD patient group
- Undergoing treatment for acute exacerbations
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to secondhand tobacco smokeThe 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. | Other | Exposure to secondhand tobacco smoke |
Primary outcome
Respiratory Rate
Time frame: 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
3 secondary outcomes
Secondhand Smoke Exposure Levels
Time frame: 1) At homes - 24 hours, during the study period; 2) in outside smoking areas - 15-60 minutes during the intervention
Medication Usage
Time frame: 24hours: pre during and post SHS exposure
Medication Usage
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- TackSHS Project at CORDISLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Clancy, MB, MD, PhD principal investigator
TobaccoFree Research Institute Ireland (TFRI)
Sheila Keogan, RGN, MPhil principal investigator
TobaccoFree Research Institute Ireland (TFRI)
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to secondhand tobacco smoke in people with COPD and Asthma, run by Institut Català d'Oncologia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Rate (time frame: 24hours to include during non exposure and exposure to SHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.