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

• ClinicalTrials.gov Identifier: NCT03383601
• Recruitment Status: Completed
• First Posted: December 26, 2017
• Last Update Posted: December 15, 2023
• Sponsor: Kazakhstan Academy of Preventive Medicine
• Collaborators: Philip Morris International; Synergy Research Group Kazakhstan; HealthCity LLP
• Information provided by (Responsible Party): Kazakhstan Academy of Preventive Medicine

Study Description

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

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

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Primary Completion Date: November 30, 2023
• Actual Study Completion Date: November 30, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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
2. Functional exercise incapacity [ Time Frame: 5 years ]
   Less than 450 meters walked during the six-minute walk test
3. 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).

Secondary Outcome Measures :

1. 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
2. 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.
3. Clinical findings by physical pulmonary exam [ Time Frame: 5 years ]
   Presence of any pathological findings during the pulmonary (percussion and inspection) exam
4. Clinical findings by physical cardiac second sounds exams [ Time Frame: 5 years ]
   Presence of any pathological findings during the cardiac second sounds exam
5. 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
6. Decreased Oxygen saturation [ Time Frame: 5 years ]
   Percentage of hemoglobin loaded with oxygen (<95%)
7. 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

Blood testing for: complete blood count (CBC), blood cholesterol level, HDL (highdensity lipoprotein), LDL (low-density lipoproteins), triglycerides, C-reactive protein, fibrinogen, glucose. Biomarker testing for sRAGE, ICAM1, CCL20 and probably other biomarkers.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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).

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

Contacts and Locations

Locations

Kazakhstan

Kazakhstan Academy of Preventive Medicine

Almaty, Kazakhstan, 050008

Sponsors and Collaborators

Kazakhstan Academy of Preventive Medicine

Philip Morris International

Synergy Research Group Kazakhstan

HealthCity LLP

Investigators

• Principal Investigator: Almaz Sharman, MD, PhD; Kazakhstan Academy of Preventive Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Kazakhstan Academy of Preventive Medicine
• ClinicalTrials.gov Identifier: NCT03383601
• Other Study ID Numbers: PMI.IIS.2016.1.1.
• First Posted: December 26, 2017
• Last Update Posted: December 15, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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 Materials: Study Protocol

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kazakhstan Academy of Preventive Medicine:

COPD; Exacerbation of respiratory symptoms; Functional exercise capacity; Heated Tobacco Products; Respiratory symptoms

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Signs and Symptoms, Respiratory; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Lung Diseases, Obstructive