Clinical trial NCT03383601: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Physical Disability
Respiratory Disease
Keywords: COPD
Exacerbation of respiratory symptoms
Functional exercise capacity
Heated Tobacco Products
Respiratory symptoms
Lead sponsor: Kazakhstan Academy of Preventive Medicine
Sponsor class: OTHER
Collaborators: name: Philip Morris International
name: Synergy Research Group
name: HealthCity LLP
First posted: 2017-12-26
Enrollment: 1200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 40-59 years inclusive
* Smoking history ≥10 pack-years (for both cohorts)
* Ability to follow study procedures

Exclusion Criteria:

Pregnant women; Legally incapable individuals;

Patients with history of:

* chronic infectious and non-infectious lung disease except asthma (e.g. pulmonary fibrosis, bronchiectasis, cystic fibrosis, tuberculosis, etc.) diagnosed prior to or during the first visit to KAPM COPD Center;
* previous surgical excision of at least one lung lobe (or having undergone a lung volume reduction procedure);
* active cancer of any localization under treatment;
* suspected cancer of any localization;
* metallic articles in the chest;
* recent eye surgery (during the last 6 month prior to the visit);
* episode (s) of myocardial infarction within less than 6 months prior to the visit or another form of acute or chronic coronary heart disease, history of heart rhythm abnormality with episode of arrhythmia within the last 6 months prior to the visit or long lasting that requires continuous drug therapy;
* acute episode of cerebrovascular ischemic attack within the last 12 month prior to the visit;
* chest or abdominal surgery performed within the last 6 month prior the visit;
* contraindications to salbutamol or refusal to inhale salbutamol;
* chest radiation therapy within the last 12 month prior to the visit; radiology diagnostic procedures of chest within the last 6 months prior to the visit;
* recent (6 weeks before the visit) respiratory tract infection (colds, flus), fever of any etiology with increasing temperature over 37 C at the time of the visit and in the last 2 weeks prior to the visit;
* significant history of alcohol abuse or consumption of more than recommended units of alcohol per week (28 units male and 21 units female);
* positive screening test for HIV antibodies or positive screening for TB, if available at the time of first visit;
* elevated blood pressure (systolic) is ≥160 mmHg at the moment of visit. PMI employees and first degree relatives

Primary outcomes:
measure: Presence of respiratory symptoms defined by CAT≥10
timeFrame: 5 years
measure: Functional exercise incapacity
timeFrame: 5 years
measure: Respiratory exacerbations
timeFrame: 5 years
Secondary outcomes:
measure: Evidence of chronic obstructive pulmonary disease
timeFrame: 5 years
measure: ECG abnormalities
timeFrame: 5 years
measure: Clinical findings by physical pulmonary exam
timeFrame: 5 years
measure: Clinical findings by physical cardiac second sounds exams
timeFrame: 5 years
measure: Metabolic syndrome
timeFrame: 5 years
measure: Decreased Oxygen saturation
timeFrame: 5 years
measure: Low Dose Computerised Tomography (LDCT) of the Chest Features
timeFrame: 5 years
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakhstan Academy of Preventive Medicine
Study officials:
affiliation: Kazakhstan Academy of Preventive Medicine
name: Almaz Sharman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharman A, Zhussupov B, Sharman D, Kim I, Yerenchina E. Lung Function in Users of a Smoke-Free Electronic Device With HeatSticks (iQOS) Versus Smokers of Conventional Cigarettes: Protocol for a Longitudinal Cohort Observational Study. JMIR Res Protoc. 2018 Nov 5;7(11):e10006. doi: 10.2196/10006.