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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04821869
Eligibility Criteria:
Inclusion Criteria:
1. Documented history of COPD by ATS/GOLD criteria
2. Age \> 45 years
3. Patient willing and able to:
1. participate in the study, including all scheduled visits
2. demonstrate the ability to use the ProAir Digihaler, including transfer of Digihaler data via blue-tooth to a smart device
3. perform all required testing, including spirometry and walk tests
4. complete all home questionnaires and participate in all telephone contacts
5. switch current rescue inhaler/device to ProAir Digihaler
4. Baseline spirometry consistent with COPD (post bronchodilator FEV1 \< 80% predicted, FEV1/FVC \<70%)
5. Use of albuterol inhaler as primary device for administration of rescue therapy
6. Reported use of rescue inhaler at least twice (4 inhalations) a week in the previous 6 months
7. Access to smartphone with blue-tooth and cellular/internet access
Exclusion Criteria:
1. Allergy, contraindication or inability to use albuterol sulfate
2. Frequent use of a nebulizer as rescue therapy (\>1 time per day)
3. Current diagnosis of asthma
4. Unstable medical condition that could prevent the completion of the research trial
5. Pregnancy, planning to become pregnant or breast feeding
6. Failure to use rescue inhaler during Run-in period (minimum of at least 8 rescue inhaler inhalations over the 2 weeks)
7. Exacerbations that require discontinuation from study (during run-in period)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT04821869
Study Brief:
Protocol Section:
NCT04821869