Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03074734 |
Other study ID # |
TackSHS WP5 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 2016 |
Est. completion date |
May 2019 |
Study information
Verified date |
August 2022 |
Source |
Institut Català d'Oncologia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 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).
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.