Clinical trial NCT03074734: Health Effects of Secondhand Smoke Exposure in Outdoor Smoking Areas in Patients With COPD and Asthma ( TackSHSWP5 )
Official title: Exposure to Secondhand Smoke in Exempted Areas/Outside Areas and Acute Health Effects in Patients With Chronic Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Asthma
Second Hand Tobacco Smoke
Keywords: secondhand smoke
passive smoking
respiratory diseases
COPD
asthma
SHS health effect
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
Collaborators: name: TobaccoFree Research Institute
name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Mario Negri Institute for Pharmacological Research
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
First posted: 2017-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

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.

Eligibility 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.

Primary outcomes:
measure: Respiratory Rate
timeFrame: 24hours to include during non exposure and exposure to SHS
Secondary outcomes:
measure: Secondhand Smoke Exposure Levels
timeFrame: 1) At homes - 24 hours, during the study period; 2) in outside smoking areas - 15-60 minutes during the intervention
measure: Medication Usage
timeFrame: 24hours: pre during and post SHS exposure
measure: Medication Usage
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: TobaccoFree Research Institute Ireland (TFRI)
name: Luke Clancy, MB, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: TobaccoFree Research Institute Ireland (TFRI)
name: Sheila Keogan, RGN, MPhil
role: PRINCIPAL_INVESTIGATOR
References: