An observational study in Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency and Physical Disability, sponsored by Kazakhstan Academy of Preventive Medicine. Completed at 1 site in Kazakhstan. Open to participants aged 40 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by Kazakhstan Academy of Preventive Medicine · Observational
This study evaluates 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
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.
5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
This study's enrollment of 1,200 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Kazakhstan Academy of Preventive Medicine is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals aged 40 - 59 who live in City of Almaty and smoke combustible cigarettes (CC smokers - control group) or predominantly use IQOS with HeatStick (exposure group).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pregnant women; Legally incapable individuals;
Patients with history of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Heated Tobacco Products: heatsticks heated by iQOS device
Current smoking of combustible cigarettes
Presence of respiratory symptoms defined by CAT≥10
The total COPD Assessment Test Scores 10 and more as an indicator of more symptoms
Time frame: 5 years
Functional exercise incapacity
Less than 450 meters walked during the six-minute walk test
Time frame: 5 years
Respiratory exacerbations
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).
Time frame: 5 years
Evidence of chronic obstructive pulmonary disease
Airflow obstruction based on the fixed ratio of post-bronchodilator FEV1 /FVC \< 0.70 criterion
Time frame: 5 years
ECG abnormalities
Presence of any ECG abnormalities including pathologic q-waves, ST elevation, ST depression, T-wave inversion, hypertrophy, QRS axis deviation, block, arrhythmia.
Time frame: 5 years
Clinical findings by physical pulmonary exam
Presence of any pathological findings during the pulmonary (percussion and inspection) exam
Time frame: 5 years
Clinical findings by physical cardiac second sounds exams
Presence of any pathological findings during the cardiac second sounds exam
Time frame: 5 years
Metabolic syndrome
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
Time frame: 5 years
Decreased Oxygen saturation
Percentage of hemoglobin loaded with oxygen (\<95%)
Time frame: 5 years
Low Dose Computerised Tomography (LDCT) of the Chest Features
Grading the severity of the following: bronchiectasis, bronchial wall thickening, emphysema, reticular pattern or honeycombing.
Time frame: 5 years
Plan to share: Yes — The investigators will share all participant data except personally identifiable information. Data will be available to open-access after the completion of the study. Access to study data, which is going to be located in our web site, will be granted by request.
Supporting information: Study protocol
Ran from Dec 2017 to primary completion in Nov 2023, 71 months.
Of 466 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's 71 months is above that.
Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Kazakhstan Academy of Preventive Medicine