?ohort 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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT03383601
• Date of registration: 07/12/2017
• Prospective Registration: Yes
• Primary sponsor: Kazakhstan Academy of Preventive Medicine
• Public title: ?ohort 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
• Scientific 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
• Date of first enrolment: December 16, 2017
• Target sample size: 1200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03383601
• Study type: Observational

Countries of recruitment

Kazakhstan

Contacts

• Name: Almaz Sharman, MD, PhD
• Affiliation: Kazakhstan Academy of Preventive Medicine

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 59 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Disease, Chronic Obstructive

Respiratory Insufficiency

Physical Disability

Respiratory Disease

Intervention(s)

Other: Smoking combustible cigarettes

Other: Heated Tobacco product IQOS/heatstick

Primary Outcome(s)

Functional exercise incapacity [Time Frame: 5 years]

Presence of respiratory symptoms defined by CAT=10 [Time Frame: 5 years]

Respiratory exacerbations [Time Frame: 5 years]

Secondary Outcome(s)

Metabolic syndrome [Time Frame: 5 years]

Clinical findings by physical pulmonary exam [Time Frame: 5 years]

Clinical findings by physical cardiac second sounds exams [Time Frame: 5 years]

Low Dose Computerised Tomography (LDCT) of the Chest Features [Time Frame: 5 years]

ECG abnormalities [Time Frame: 5 years]

Evidence of chronic obstructive pulmonary disease [Time Frame: 5 years]

Decreased Oxygen saturation [Time Frame: 5 years]

Secondary ID(s)

PMI.IIS.2016.1.1.

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Synergy Research Group Kazakhstan

HealthCity LLP

Philip Morris International