Pulmonary Disease, Chronic ObstructiveNCT03383601
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
An observational study of Pulmonary Disease, Chronic Obstructive and Respiratory Insufficiency, run by Kazakhstan Academy of Preventive Medicine at 1 site in Kazakhstan.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, Physical Disability
- What is being tested?
- Heated Tobacco product IQOS/heatstick and Smoking combustible cigarettes
- How many people
- 1,200 participants
- Where
- 1 siteKazakhstan
- Study dates
- 16 Dec 2017to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- Male or female
- Age 40-59 years inclusive
- Smoking history ≥10 pack-years (for both cohorts)
- Ability to follow study procedures
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- Heated Tobacco product IQOS/heatstick, Smoking combustible cigarettes
- Keywords
- COPD, Exacerbation of respiratory symptoms, Functional exercise capacity, Heated Tobacco Products, Respiratory symptoms
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency, Respiration Disorders, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated Tobacco product IQOS/heatstickOther
Heated Tobacco Products: heatsticks heated by iQOS device
Smoking combustible cigarettesOther
Current smoking of combustible cigarettes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Smoking combustible cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of respiratory symptoms defined by CAT≥10
The total COPD Assessment Test Scores 10 and more as an indicator of more symptoms
Measured: 5 years
Functional exercise incapacity
Less than 450 meters walked during the six-minute walk test
Measured: 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).
Measured: 5 years
Secondary outcomes (7)
Evidence of chronic obstructive pulmonary disease
Airflow obstruction based on the fixed ratio of post-bronchodilator FEV1 /FVC < 0.70 criterion
Measured: 5 years
ECG abnormalities
Presence of any ECG abnormalities including pathologic q-waves, ST elevation, ST depression, T-wave inversion, hypertrophy, QRS axis deviation, block, arrhythmia.
Measured: 5 years
Clinical findings by physical pulmonary exam
Presence of any pathological findings during the pulmonary (percussion and inspection) exam
Measured: 5 years
Clinical findings by physical cardiac second sounds exams
Presence of any pathological findings during the cardiac second sounds exam
Measured: 5 years
Metabolic syndrome
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
Measured: 5 years
Decreased Oxygen saturation
Percentage of hemoglobin loaded with oxygen (<95%)
Measured: 5 years
Low Dose Computerised Tomography (LDCT) of the Chest Features
Grading the severity of the following: bronchiectasis, bronchial wall thickening, emphysema, reticular pattern or honeycombing.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start16 Dec 2017
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazakhstan Academy of Preventive Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Philip Morris International, Synergy Research Group, HealthCity LLP
- Responsible party
- Sponsor
- Investigators
- Almaz Sharman, MD, PhD, Principal investigator, Kazakhstan Academy of Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383601
- Sponsor's protocol ID
- PMI.IIS.2016.1.1.
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2017
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 30401669
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03383601
- Acronym / sponsor ID
- PMI.IIS.2016.1.1.
- 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 type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Kazakhstan Academy of Preventive MedicineUniversity, hospital or other
- Collaborators
- Philip Morris International, Synergy Research Group, HealthCity LLP
- Study start
- 16 Dec 2017 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Users of IQOS with HeatStick | – | Other: Heated Tobacco product IQOS/heatstickIndividuals (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 |
| Smokers of combustible cigarettes | – | Other: Smoking combustible cigarettesIndividuals (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 |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- Male or female
- Age 40-59 years inclusive
- Smoking history ≥10 pack-years (for both cohorts)
- Ability to follow study procedures
Key exclusion criteria (17 listed)
- Pregnant women; Legally incapable individuals;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heated Tobacco product IQOS/heatstickHeated Tobacco Products: heatsticks heated by iQOS device | Other | Users of IQOS with HeatStick |
| Smoking combustible cigarettesCurrent smoking of combustible cigarettes | Other | Smokers of combustible cigarettes |
Primary outcome
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
Functional exercise incapacity
Time frame: 5 years
Less than 450 meters walked during the six-minute walk test
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).
7 secondary outcomes
Evidence of chronic obstructive pulmonary disease
Time frame: 5 years
ECG abnormalities
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
Metabolic syndrome
Time frame: 5 years
Decreased Oxygen saturation
Time frame: 5 years
Low Dose Computerised Tomography (LDCT) of the Chest Features
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 30401669Sharman 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Almaz Sharman, MD, PhD principal investigator
Kazakhstan Academy of Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Respiratory Insufficiency, run by Kazakhstan Academy of Preventive Medicine at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of respiratory symptoms defined by CAT≥10 (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03383601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.