| Eligibility |
Inclusion Criteria:
1. Participant must sign an ICF and is willing to participate in the study
2. Male or female participant must be of = 40 years of age
3. Be medically stable on the basis of physical examination, medical history, and vital
signs, chest X-ray and 12-lead ECG performed at screening. Any abnormalities, must be
consistent with the underlying illness in the study population and recorded
4. Be medically stable on the basis of clinical laboratory tests performed at screening
as defined.
5. Participants with documented Diagnosis of COPD, as defined by American Thoracic
Society (ATS) [GOLD criteria] at screening.
6. Pre-bronchodilator FEV1 = 35% and = 80% of predicted at screening and visits 3-5 as
defined.
7. Demonstrate at screening, post-bronchodilator FEV1=80% of predicted.
8. Must demonstrate at screening, post-bronchodilator FEV1/FVC ratio =0.70
9. Demonstrate = 15 % reversibility of FEV1 within 45 minutes following 4 inhalations of
bronchodilator inhalation aerosol (84 mcg).
10. Must administer at least 70% doses of placebo during the run-in period.
11. Current or former cigarette smokers with a history of cigarette smoking of =10
pack-years at Screening (visit 1)
12. Not pregnant , breastfeeding, not a woman of childbearing potential (WOCBP) or WOCBP
using an acceptable contraceptive
13. Participants willing and able to adhere to the protocol lifestyle restrictions
14. Participants able to understand and comply with the study procedures.
Exclusion Criteria:
1. Participants with history of liver or defined renal insufficiency; significant
cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic,
rheumatologic, psychiatric, or metabolic disturbances.
2. Known respiratory disorder other than COPD, including but not limited to the
following: active tuberculosis, lung cancer, alpha-1-antitrypsin deficiency, cystic
fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis,
pulmonary hypertension, pulmonary edema or interstitial lung disease
3. Participants with a1-antitrypsin deficiency as the underlying cause of COPD at
screening.
4. Participants with history of paradoxical bronchospasm, narrow-angle glaucoma,
prostatic hypertrophy, or bladder neck obstruction, which would contraindicate the use
of an anticholinergic agent.
5. Participants with history of allergy or hypersensitivity to anticholinergic/muscarinic
receptor antagonist agent, beta-2 adrenergic agonists, lactose/milk proteins or
specific intolerance to aerosolized tiotropium or ipratropium bromide-containing
products or known hypersensitivity to any of the proposed ingredients or components of
the delivery system.
6. Participants with abnormal and clinically significant electrocardiogram (ECG) finding
prior to the study screening and randomization as per investigator discretion.
7. Participants with use of oral/parenteral corticosteroids or antibiotics for COPD
within 6 weeks or depot corticosteroids within 3 months prior to screening.
8. Participants with hospitalization for COPD or pneumonia within 12 weeks prior to study
screening and randomization.
9. Participants with treatment for COPD exacerbation within 12 weeks prior to study
screening and randomization.
10. Participants with acute (viral or bacterial) upper or lower respiratory tract
infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within
6 weeks prior to screening.
11. Patients with sign and/or symptoms suggestive of COVID 19 infection at the time of
screening.
12. Participants with lung volume reduction surgery within the previous 12 months of
randomization.
13. Participants with chronic oxygen uses for >12 hours/day.
14. Participants with evidence or history of other clinically significant disease or
abnormal (such as congestive heart failure, uncontrolled hypertension, uncontrolled
coronary artery disease, myocardial infarction, stroke, glaucoma or cardiac
dysrhythmia) condition for which participation would not be in the best interest of
the participant or that could prevent, limit, or confound the protocol-specified
assessments.
15. Participants had major surgery, (e.g., requiring general anesthesia) within 8 weeks
before screening, or will not have fully recovered from surgery, or has surgery
planned during the time of the study.
16. Participants with history of hepatitis B surface antigen (HBsAg) or hepatitis C
antibody (anti-HCV) positive, or other clinically active liver disease, or tests
positive for HBsAg or anti-HCV at Screening.
17. Participants with history of human immunodeficiency virus (HIV) antibody positive, or
tests positive for HIV at Screening.
18. Participant is unable to stop the medications at the defined times prior to screening
19. Participants with history of drug or alcohol abuse within 1 years before screening or
positive test result(s) for alcohol or drugs of abuse at Screening.
20. Intended use of over the counter or prescription medication including herbal
medications within 14 days prior to dosing.
21. Participants received an investigational intervention (including investigational
vaccines) or used an invasive investigational medical device within 30 days or 5
half-lives prior to baseline, whichever is longer, or is currently enrolled in an
investigational study.
22. Participants who are medically unable to withhold participant's salbutamol for the at
least 4-hour period required prior to spirometry testing at each study visit.
23. Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this
study or within 2 weeks after the last dose of study intervention.
24. Plans to father a child while enrolled in this study or within 2 weeks after the last
dose of study intervention.
25. Participants that experiences a moderate or a severe COPD exacerbation or pneumonia
during the run-in period will be excluded.
26. Participants requires nocturnal oxygen or continuous supplemental oxygen therapy.
27. Participant that requires a change in COPD medication from rescue medication or
participants required rescue medications more than acceptable frequency during the
screening or run-in period will be excluded.
28. Employee of the investigator or study site
29. Participants unable to perform maneuver (correct inhalation technique) according to
study requirement despite device training
30. Participants unable to perform acceptable or repeatable spirometry or comply with
other study procedures
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