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Beta-2 Agonist
2 for Chronic Obstructive Pulmonary Disease
Phase 3
Waitlist Available
Research Sponsored by Sumitomo Pharma America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
Summary
The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD
Eligible Conditions
- Chronic Obstructive Pulmonary Disease
- CPFE Syndrome
- Bronchitis
- Emphysema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 3Experimental Treatment1 Intervention
Arformoterol 15 mcg BID and placebo MDI
Group II: 2Experimental Treatment1 Intervention
Arformoterol 25 mcg BID and Placebo MDI
Group III: 1Experimental Treatment1 Intervention
Arformoterol 50 mcg QD and placebo MDI
Group IV: 4Active Control1 Intervention
Salmeterol MDI 42 mcg BID and placebo inhalation solution
Group V: 5Placebo Group1 Intervention
Placebo MDI and placebo inhalation solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arformoterol
FDA approved
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Who is running the clinical trial?
Sumitomo Pharma America, Inc.Lead Sponsor
241 Previous Clinical Trials
51,133 Total Patients Enrolled
SunovionLead Sponsor
189 Previous Clinical Trials
48,621 Total Patients Enrolled
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