Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Recruiting in Palo Alto (17 mi)
+16 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Pearl Therapeutics, Inc.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD
Research Team
CR
Colin Reisner, MD
Principal Investigator
Pearl Therapeutics, Inc.
Eligibility Criteria
Inclusion Criteria
Signed written informed consent
40 - 80 years of age
Clinical history of COPD with airflow limitation that is not fully reversible
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Treatment Details
Interventions
- Glycopyrrolate/Formoterol Fumarate MDI (Anticholinergic/Beta2-agonist Combination)
- Tiotropium inhalation powder (Anticholinergic)
Participant Groups
8Treatment groups
Experimental Treatment
Active Control
Group I: PT005Experimental Treatment1 Intervention
PT005 MDI
Group II: PT003 (Dose 5)Experimental Treatment1 Intervention
PT003 MDI Dose 5
Group III: PT003 (Dose 4)Experimental Treatment1 Intervention
PT003 MDI Dose 4
Group IV: PT003 (Dose 3)Experimental Treatment1 Intervention
PT003 MDI Dose 3
Group V: PT003 (Dose 2)Experimental Treatment1 Intervention
PT003 MDI Dose 2
Group VI: PT003 (Dose 1)Experimental Treatment1 Intervention
PT003 MDI Dose 1
Group VII: PT001Experimental Treatment1 Intervention
PT001 MDI
Group VIII: Spiriva® Handihaler®Active Control1 Intervention
Tiotropium Bromide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pearl Therapeutics, Inc.
Lead Sponsor
Trials
42
Recruited
25,700+
Founded
2006
Headquarters
Redwood City, USA
Known For
Respiratory therapies
Top Products
PT003, PT010