N/A
N=60
Health Effects of Secondhand Smoke Exposure in Outdoor Smoking Areas in Patients With COPD and Asthma ( TackSHSWP5 )
COPD · Asthma · Second Hand Tobacco Smoke
Bottom Line
View on ClinicalTrials.gov: NCT03074734 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Respiratory Rate — 21.66; 21.57 BR/M breathing rate per min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exposure to secondhand tobacco smoke (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Català d'Oncologia
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Rate |
21.66; 21.57 | — |
| SECONDARY Secondhand Smoke Exposure Levels |
101.45; 233.59 | — |
| SECONDARY Medication Usage |
0; 0 | — |
| SECONDARY Medication Usage |
0; 0 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT03074734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.