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Label indication OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. OHTUVAYRE is a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. ( 1 ) FDA label
Ensifentrine · 1 trial · 1 indication
Change from baseline of Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)0-12h
| Arm | Type | Description |
|---|---|---|
| Ensifentrine | EXPERIMENTAL | Eligible subjects will be randomly assigned in a 5:3 ratio to receive either Ensifentrine or placebo. Doses and methods of administration are as follows: Ensifentrine (RPL554) 3 mg BID or placebo BID will be administered by aerosol inhalation for 24 weeks; each nebulization time wil be approximately 5 minutes. |
| Placebo | PLACEBO_COMPARATOR | Eligible subjects will be randomly assigned in a 5:3 ratio to receive either Ensifentrine or placebo. Doses and methods of administration are as follows: Ensifentrine (RPL554) 3 mg BID or placebo BID will be administered by aerosol inhalation for 24 weeks; each nebulization time wil be approximately 5 minutes. |
| Name | Type | Description |
|---|---|---|
| Ensifentrine | DRUG | A dual PDE3/PDE 4 inhibitor |
| Placebo | DRUG | Placebo solution |
Inclusion Criteria: 1. Patient must be 40 to 80 years of age inclusive, at the time of Screening, male or female; 2. Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack-years; 3. Patients with a clear clinical history of COPD and related symptoms prior to screening; 4....