Subjects With Persistent Asthma
Conditions
Interventions
Trade Name: Glycopyrronium Metered Dose Inhaler
Product Name: Glycopyrronium Inhalation Aerosol
Product Code: GP MDI
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Glycopyrronium
CAS Nu
Sponsors
Pearl Therapeutics Inc.
Pearl Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Give their signed written informed consent (and assent as appropriate) to participate 2. Are at least 12 years of age and no older than 80 years 3. Have a documented history of physician-diagnosed asthma 4. Require inhaled asthma maintenance therapy: has been regularly using an ICS/LABA on a stable regimen, with the ICS doses allowed in Table 5 1, for at least 4 weeks prior. Subjects may be included if also receiving tiotropium 2.5 µg QD for at least 4 weeks prior. 5. ACQ-5 total score =1.5 at Visit 2 6. Based on the average of 2 assessments, pre-bronchodilator FEV1 >40% and 40% and =65 years) yes F.1.3.1 Number of subjects for this age range 275
Exclusion criteria
Exclusion criteria: 1. Oral corticosteroid use (any dose) within 4 weeks 2. Received any marketed (eg, omalizumab) or investigational biologic within 3 months or 5 half-lives, whichever is longer, or any other medication specifically prohibited by the protocol within the indicated exclusionary time periods (Table 5 4 and Table 5 5) 3. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months previously (including all forms of tobacco, e-cigarettes, and marijuana) 4. Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) 5. Completed treatment for lower respiratory infection or asthma exacerbation within 4 weeks 6. Upper respiratory infection not resolved within 7 days 7. Hospitalizations for asthma within 3 months 8. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal, hematological, neurological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, Cushing’s syndrome), gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease), or pulmonary (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or that could affect the efficacy or safety analysis if the disease/condition exacerbated during the study 9. Pacemaker or implantable cardioverter-defibrillator/cardiac resynchronization therapy/cardiac resynchronization therapy-defibrillator devices 10. Narrow angle glaucoma not adequately treated. All medications approved for control of intraocular pressures are allowed, including topical ophthalmic non-selective ß-blockers 11. Symptomatic prostatic hypertrophy that in the opinion of the Investigator is clinically significant and not adequately controlled with appropriate therapy Note: Subjects with a trans-urethral resection of prostate or full resection of the prostate within 6 months prior to Visit 1 are excluded from the study. 12. Bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator 13. Calculated creatinine clearance =30 mL/minute using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula for subjects 19 to 80 years of age or the Schwartz formula for subjects 12 to <19 years of age and on repeat testing prior to Visit 4 14. Abnormal liver function tests, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin (TBL) =1.5 times the upper limit of normal (ULN) at Visit 1 and on repeat testing prior to Visit 2 (Note: Chronic stable hepatitis B or C is acceptable) 15. Cancer not in complete remission for at least 5 years Note: Subjects with squamous cell carcinoma of the skin, basal cell carcinoma of the skin, in situ carcinoma of the cervix, or localized prostate cancer are eligible if, in the opinion of the Investigator, the condition has been adequately worked up and clinically controlled and the subject’s participation in the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of 3 doses of GP MDI compared to Placebo MDI and Spiriva® Respimat® on lung function over 24 weeks in subjects with persistent asthma.;Secondary Objective: To assess the effect of 3 doses of GP MDI compared to Placebo MDI and Spiriva Respimat on exacerbations, quality of life, and symptoms over 24 weeks in subjects with persistent asthma.;Primary end point(s): •Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) at Week 24;Timepoint(s) of evaluation of this end point: •Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline in morning pre-dose trough FEV1 at Week 24 • Time to first moderate/severe asthma exacerbation • Change from baseline in Asthma Control Questionnaire (ACQ)–7 at Week 24 • Change from baseline in ACQ-5 at Week 24 • Change from baseline in Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) at Week 24;Timepoint(s) of evaluation of this end point: • Change from baseline in morning pre-dose trough FEV1 at Week 24 • Time to first moderate/severe asthma exacerbation • Change from baseline in Asthma Control Questionnaire (ACQ)–7 at Week 24 • Change from baseline in ACQ-5 at Week 24 • Change from baseline in Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) at Week 24 | — |
Countries
United States
Contacts
Public ContactColin Reisner
AstraZeneca
Outcome results
None listed