Status:
COMPLETED
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
Lead Sponsor:
Kazakhstan Academy of Preventive Medicine
Collaborating Sponsors:
Philip Morris International
Synergy Research Group
Conditions:
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Eligibility:
All Genders
40-59 years
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 ...
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 th...
Eligibility Criteria
Inclusion
- Male or female
- Age 40-59 years inclusive
- Smoking history ≥10 pack-years (for both cohorts)
- Ability to follow study procedures
Exclusion
- 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
Key Trial Info
Start Date :
December 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03383601
Start Date
December 16 2017
End Date
November 30 2023
Last Update
December 15 2023
Active Locations (1)
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1
Kazakhstan Academy of Preventive Medicine
Almaty, Kazakhstan, 050008