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

NCT03383601 | Completed

• 1 other identifier: PMI.IIS.2016.1.1.
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (3)

• Presence of respiratory symptoms defined by CAT≥10

  The total COPD Assessment Test Scores 10 and more as an indicator of more symptoms

  5 years

• Functional exercise incapacity

  Less than 450 meters walked during the six-minute walk test

  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).

  5 years

Secondary Outcomes (7)

• Evidence of chronic obstructive pulmonary disease

  5 years

• ECG abnormalities

  5 years

• Clinical findings by physical pulmonary exam

  5 years

• Clinical findings by physical cardiac second sounds exams

  5 years

• Metabolic syndrome

  5 years

Study Arms (2)

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

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

Interventions

Heated Tobacco product IQOS/heatstick OTHER

Heated Tobacco Products: heatsticks heated by iQOS device

Users of IQOS with HeatStick

Smoking combustible cigarettes OTHER

Current smoking of combustible cigarettes

Smokers of combustible cigarettes

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• 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);

Sponsors & Collaborators

• Kazakhstan Academy of Preventive Medicine: lead
• Philip Morris International: collaborator
• Synergy Research Group: collaborator
• HealthCity LLP: collaborator

Study Sites (1)

Kazakhstan Academy of Preventive Medicine

Almaty, 050008, Kazakhstan

Location

Related Publications (1)

• 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.

  PMID: 30401669 DERIVED

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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Respiration Disorders; Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Almaz Sharman, MD, PhD

  Kazakhstan Academy of Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 26, 2017
• Study Start: December 16, 2017
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

KA (1)