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:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT04296318
Eligibility Criteria:
Inclusion Criteria:
1. Aged 40 years or over.
2. Diagnosis of COPD Stage 2-4 (GOLD I-IV) by spirometry.
3. Be a frequent exacerbator ie. ≥2 moderate exacerbations in the past 12 months.
4. Current or ex-smokers with a smoking history of at least 10 pack-years.
5. Be willing and able to comply with study procedures and be available for study visits
6. Be able to use a 'smart phone'.
7. Be able to give written consent.
8. Able to understand written and spoken English. -
Exclusion Criteria:
1. Inability to give written informed consent
2. Known respiratory disorders other than COPD which, in the opinion of the investigator, is the main contributor to patient's symptoms (e.g. asthma, lung cancer, sarcoidosis and other interstitial lung disease (ILDs), tuberculosis, lung fibrosis, cystic fibrosis, and non-COPD related bronchiectasis).
3. Known history of significant systemic and other organ-related disease, other than COPD, which in the opinion of investigator, is likely to interfere with the study or impact on subject safety (e.g. severe rheumatoid arthritis and Lupus, kidney, liver, endocrine, psychological disorders).
4. Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ).
5. Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months.
6. Have cancer, or other terminal condition, which, in the opinion of investigator, has a mortality of 12 months or less.
7. Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
8. Taking high dose oral corticosteroid medication (equivalent to daily dose of ≥10mg of prednisolone) for more than 3 consecutive months.
9. Pregnancy
10. Participation in an interventional clinical study within 3 months of Visit 1 or participation in a study using an investigational medicinal product (IMP) either in the previous 3 months or in the interval from last using the IMP to 5 times its half-life.
11. Patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the IVD device, or complete the questionnaires), or at the Clinician's discretion for other more significant medical/social reasons.
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Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04296318
Study Brief:
Protocol Section:
NCT04296318