Сohort Study to Evaluate Exacerbations, Respiratory Symptoms, Physical Exercise Intolerance and Lung Functions Among Participants Who Use IQOS With Heatsticks Compared to Smokers of Conventional Cigarettes
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|ClinicalTrials.gov Identifier: NCT03383601|
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment|
|Pulmonary Disease, Chronic Obstructive Respiratory Insufficiency Physical Disability Respiratory Disease||Other: Heated Tobacco product IQOS/heatstick Other: Smoking combustible cigarettes|
Heated Tobacco Products, such as Heatsticks heated by iQOS device, are specially designed tobacco products that contain tobacco material and several filter sections. Recent studies demonstrate that the vapor from Heatsticks heated by iQOS device contains 90 to 95% less harmful and potentially harmful compounds ("HPHCs") and is 90 to 95% less toxic than the smoke of a reference combustible cigarette.
IQOS with HeatSticks may serve as less risky alternatives to combustible cigarettes and to other traditional tobacco products in clinical setting. The investigators hypothesize that participants using IQOS with HeatSticks will have less prevalent presence of respiratory symptoms, have better functional exercise capacity, and experience less exacerbations compared to those who smoke combustible cigarettes by demonstrating whether the trends of the response variables across time is the same between the exposure and the control groups.
This 5-years observational study includes two cohorts of participants age 40 - 59: (1) smokers of combustible cigarettes (CC smokers -control group) and (2) users of IQOS with HeatStick (exposure group). The study has baseline and periodic (annual) comprehensive clinical assessments, as well as continuous COPD case-finding activities and registering acute exacerbations of COPD.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||A 5-year Cohort Observational Study to Evaluate Frequency of Exacerbations, Respiratory Symptoms, Physical Exercise Intolerance and Abnormal Lung Functions Among Participants Who Use IQOS With Heatsticks Compared to Smokers of Conventional Cigarettes|
|Actual Study Start Date :||December 16, 2017|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||October 31, 2023|
Users of IQOS with HeatStick
Individuals (men and women) between the ages of 40 and 59 (inclusive) with a minimum of 10 pack-year smoking history who switched to and predominantly (>70%) use Heated Tobacco product IQOS/heatstick
Other: Heated Tobacco product IQOS/heatstick
Heated Tobacco Products: heatsticks heated by iQOS device
Smokers of combustible cigarettes
Individuals (men and women) between the ages of 40 and 59 (inclusive) who are currently smoking combustible cigarettes with a minimum of 10 pack-year smoking history
Other: Smoking combustible cigarettes
Current smoking of combustible cigarettes
- Presence of respiratory symptoms defined by CAT≥10 [ Time Frame: 5 years ]The total COPD Assessment Test Scores 10 and more as an indicator of more symptoms
- Functional exercise incapacity [ Time Frame: 5 years ]Less than 450 meters walked during the six-minute walk test
- Respiratory exacerbations [ Time Frame: 5 years ]A worsening of respiratory symptoms, which required treatment with oral corticosteroids or antibiotics, or both or a health care utilization event (office visit, hospital admission, or emergency department visit for a respiratory flare-up).
- Evidence of chronic obstructive pulmonary disease [ Time Frame: 5 years ]Airflow obstruction based on the fixed ratio of post-bronchodilator FEV1 /FVC < 0.70 criterion
- ECG abnormalities [ Time Frame: 5 years ]Presence of any ECG abnormalities including pathologic q-waves, ST elevation, ST depression, T-wave inversion, hypertrophy, QRS axis deviation, block, arrhythmia.
- Clinical findings by physical pulmonary exam [ Time Frame: 5 years ]Presence of any pathological findings during the pulmonary (percussion and inspection) exam
- Clinical findings by physical cardiac second sounds exams [ Time Frame: 5 years ]Presence of any pathological findings during the cardiac second sounds exam
- Metabolic syndrome [ Time Frame: 5 years ]Presence of metabolic syndrome based on the IDF definition: Central obesity (defined as waist circumference with ethnicity specific values) PLUS any two of the following four factors: raised triglycerides; reduced HDL cholesterol; raised blood pressure; raised fasting plasma glucose
- Quality of life [ Time Frame: 5 years ]Quality of life assessment score using the Short Form-12 (SF-12) questionnaire
- Decreased Oxygen saturation [ Time Frame: 5 years ]Percentage of hemoglobin loaded with oxygen (<95%)
- Low Dose Computerised Tomography (LDCT) of the Chest Features [ Time Frame: 5 years ]Grading the severity of the following: bronchiectasis, bronchial wall thickening, emphysema, reticular pattern or honeycombing.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383601
|Kazakhstan Academy of Preventive Medicine|
|Almaty, Kazakhstan, 050008|
|Principal Investigator:||Almaz Sharman, MD, PhD||Kazakhstan Academy of Preventive Medicine|