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

NCT ID: NCT03383601

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-16
• Study Completion Date: 2023-11-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Heated Tobacco product IQOS/heatstick

Intervention Type: OTHER

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

Smoking combustible cigarettes

Intervention Type: OTHER

Current smoking of combustible cigarettes

Interventions

Heated Tobacco product IQOS/heatstick

Heated Tobacco Products: heatsticks heated by iQOS device

Intervention Type: OTHER

Smoking combustible cigarettes

Current smoking of combustible cigarettes

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philip Morris International

INDUSTRY

Sponsor Role: collaborator

Synergy Research Group

INDUSTRY

Sponsor Role: collaborator

HealthCity LLP

UNKNOWN

Sponsor Role: collaborator

Kazakhstan Academy of Preventive Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Almaz Sharman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kazakhstan Academy of Preventive Medicine

Locations

Kazakhstan Academy of Preventive Medicine

Almaty, , Kazakhstan

Countries

Kazakhstan

References

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.

Reference Type: DERIVED

PMID: 30401669 (View on PubMed)

Other Identifiers

PMI.IIS.2016.1.1.

Identifier Type: -

Identifier Source: org_study_id