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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

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ClinicalTrials.gov Identifier: NCT03383601
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
Philip Morris International
Synergy Research Group Kazakhstan
HealthCity LLP
Information provided by (Responsible Party):
Kazakhstan Academy of Preventive Medicine

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

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Respiratory Insufficiency Physical Disability Respiratory Disease Other: Heated Tobacco product IQOS/heatstick Other: Smoking combustible 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.


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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 16, 2017
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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
Other: Smoking combustible cigarettes
Current smoking of combustible cigarettes




Primary Outcome Measures :
  1. 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

  2. Functional exercise incapacity [ Time Frame: 5 years ]
    Less than 450 meters walked during the six-minute walk test

  3. 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).


Secondary Outcome Measures :
  1. Evidence of chronic obstructive pulmonary disease [ Time Frame: 5 years ]
    Airflow obstruction based on the fixed ratio of post-bronchodilator FEV1 /FVC < 0.70 criterion

  2. ECG abnormalities [ Time Frame: 5 years ]
    Presence of any ECG abnormalities including pathologic q-waves, ST elevation, ST depression, T-wave inversion, hypertrophy, QRS axis deviation, block, arrhythmia.

  3. Clinical findings by physical pulmonary exam [ Time Frame: 5 years ]
    Presence of any pathological findings during the pulmonary (percussion and inspection) exam

  4. Clinical findings by physical cardiac second sounds exams [ Time Frame: 5 years ]
    Presence of any pathological findings during the cardiac second sounds exam

  5. Metabolic syndrome [ Time Frame: 5 years ]
    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

  6. Quality of life [ Time Frame: 5 years ]
    Quality of life assessment score using the Short Form-12 (SF-12) questionnaire

  7. Decreased Oxygen saturation [ Time Frame: 5 years ]
    Percentage of hemoglobin loaded with oxygen (<95%)

  8. Low Dose Computerised Tomography (LDCT) of the Chest Features [ Time Frame: 5 years ]
    Grading the severity of the following: bronchiectasis, bronchial wall thickening, emphysema, reticular pattern or honeycombing.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383601


Locations
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Kazakhstan
Kazakhstan Academy of Preventive Medicine
Almaty, Kazakhstan, 050008
Sponsors and Collaborators
Kazakhstan Academy of Preventive Medicine
Philip Morris International
Synergy Research Group Kazakhstan
HealthCity LLP
Investigators
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Principal Investigator: Almaz Sharman, MD, PhD Kazakhstan Academy of Preventive Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kazakhstan Academy of Preventive Medicine
ClinicalTrials.gov Identifier: NCT03383601     History of Changes
Other Study ID Numbers: PMI.IIS.2016.1.1.
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kazakhstan Academy of Preventive Medicine:
COPD
Exacerbation of respiratory symptoms
Functional exercise capacity
Heated Tobacco Products
Respiratory symptoms

Additional relevant MeSH terms:
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Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiration Disorders
Respiratory Tract Diseases
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Signs and Symptoms, Respiratory
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms