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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT03104634
Eligibility Criteria:
Inclusion Criteria:
* Current and former smokers with ≥20 pack-years of smoking history
* Gas-trapping (residual volume \>110% predicted)
Exclusion Criteria:
Physician-diagnosis of chronic obstructive pulmonary disease in the past 1 year and regular use of long-acting antimuscarinic (LAMA) and/or long-acting beta-agonist (LABA) (i.e., at least 30 consecutive days)
* Physician-diagnosis of asthma in the past 5 years
* Regular inhaled corticosteroid (ICS) use in the past 5 years (i.e., at least 30 consecutive days)
* Physician-diagnosis of other lung diseases (sarcoidosis, tuberculosis, cystic fibrosis, pulmonary fibrosis, lung cancer), or long-term oxygen therapy
* Respiratory tract infection within 4-weeks
* Physician-diagnosis of arrhythmia, or significant valvular disease.
* Physician-diagnosis of myocardial infarction, unstable angina or heart failure requiring unscheduled outpatient or emergency department visit within 6-months.
* Arrhythmia or prolonged corrected QT (QTc) on electrocardiogram.
* Inability to use study inhaler
* Glaucoma
* Benign prostatic hypertrophy
* Pregnancy
* Allergy to the study treatment, salbutamol, lidocaine, or severe milk protein allergy (note: lactose intolerance is not an exclusion criteria)
* Contraindications to anti-cholinergic, beta-agonist, or cardiopulmonary exercise testing with manometry
* Inability to provide written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT03104634
Study Brief:
Protocol Section:
NCT03104634