Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-24 @ 12:57 PM
NCT ID:
NCT04081961
Eligibility Criteria:
Inclusion Criteria:
* Current smokers who are currently smoking conventional cigarettes with a minimum of 10 pack-year smoking history
* Able to use and willing to be trained to use mHealth devices
Exclusion Criteria:
* COPD exacerbation that has not resolved at least 28 days prior to screening
* COPD exacerbation occurring after screening but before the first study visit
* Pneumonia or other respiratory tract infections that have not resolved at least 14 days prior to screening
* Pneumonia occurring after screening but before the first study visit
* Active respiratory disorders: tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, bronchial asthma, lung fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases
* Any co-morbid medical condition that in the opinion of the investigator would make participation in the study unsafe or unfeasible, including conditions that prohibit completion of exercise testing
* Use of supplemental oxygen therapy
* Inability to abstain from smoking during the period in which the participant is admitted to the Kazakhstan Academy of Preventive Medicine (KAPM) COPD Center
* A history of allergy or hypersensitivity to metal, particularly stainless steel
* Any vital sign indicator, for example, hypertension or tachycardia at rest that, at the discretion of the investigator, would make participation in the study unsafe or unfeasible
* Women who test positive for pregnancy during screening, lactating women, or women planning on becoming pregnant during the study
* Participants using assistive devices like walking aids, as these are likely to interfere with physical activity
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
59 Years
Study:
NCT04081961
Study Brief:
Protocol Section:
NCT04081961