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NCT03383601Completed

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

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

Source: ClinicalTrials.gov · Last updated 15 Dec 2023

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
1200 (actual)
First submitted
7 Dec 2017
Start date
16 Dec 2017
Primary completion date
30 Nov 2023
Lead sponsor
Kazakhstan Academy of Preventive Medicine
Diseases
COPD
NCT number
NCT03383601

What you commit to

  • Study type: Observational
  • Participants enrolled: 1200
  • From 16 Dec 2017 to the primary completion date, 30 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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);
  • 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;
  • 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;

Other illness

  • Patients with history of:
  • active cancer of any localization under treatment;
  • suspected cancer of any localization;
  • 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;

Other

  • Pregnant women; Legally incapable individuals;
  • metallic articles in the chest;
  • contraindications to salbutamol or refusal to inhale salbutamol;
  • elevated blood pressure (systolic) is ≥160 mmHg at the moment of visit. PMI employees and first degree relatives

Who the study is looking for

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

Age in the registry: 40 years to 59 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kazakhstan Academy of Preventive Medicine
Coordinator of this site? Confirm its status
AlmatyKazakhstanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.