Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04535986 | A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD | PHASE3 | COMPLETED | 763 | — | — | Sep 29, 2020 | Dec 2, 2022 | Nov 13, 2023 | 122 | United States, Bulgaria +10 |
| NCT04542057 | A Phase 3 Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD | PHASE3 | COMPLETED | 790 | — | — | Sep 22, 2020 | Jul 6, 2022 | Oct 16, 2023 | 130 | United States, Belgium +8 |
| NCT07132983 | A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease | PHASE2 | COMPLETED | 33 | — | — | Oct 6, 2025 | Nov 28, 2025 | Jan 8, 2026 | 4 | United States |
| NCT07016412 | A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD | PHASE2 | RECRUITING | 480 | — | — | Jul 31, 2025 | Aug 5, 2026 | May 13, 2026 | 55 | United States |
Forced spirometry maneuvers including the FEV1 were used to assess pulmonary function. Average FEV1 AUC0-12h was defined as AUC over 12 hours of the FEV1, divided by 12 hours. Baseline FEV1 is the mean of the 2 measurements taken before study medication on the day of first dosing, that is, \<=40 minutes pre-dose on Day 1. Spirometry assessments were performed in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Ensifentrine Nebulized Suspension; 3 mg BID |
| Arm 2 | PLACEBO_COMPARATOR | Placebo Nebulized BID |
| Treatment A: Ensifentrine plus Glycopyrrolate | EXPERIMENTAL | (fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to |
| Treatment B: Ensifentrine monotherapy | EXPERIMENTAL | (fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to |
| Treatment C: Glycopyrrolate monotherapy | EXPERIMENTAL | (fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to |
| Treatment D: Ensifentrine monotherapy | EXPERIMENTAL | (fixed-dose combination formulation) Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to |
| Treatment E: Ensifentrine monotherapy (marketed formulation) | EXPERIMENTAL | Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to |
| Treatment Arm A: Ensifentrine plus Glycopyrrolate | EXPERIMENTAL | Ensifentrine 3 mg / Glycopyrrolate 42.5 mcg |
| Treatment Arm B: Ensifentrine plus Glycopyrrolate | EXPERIMENTAL | Ensifentrine 3 mg / Glycopyrrolate 21.25 mcg |
| Treatment Arm C: Glycopyrrolate | ACTIVE_COMPARATOR | Glycopyrrolate monotherapy 42.5 mcg |
| Treatment Arm D: Glycopyrrolate | ACTIVE_COMPARATOR | Glycopyrrolate monotherapy 21.25 mcg |
| Treatment Arm E: Ensifentrine | ACTIVE_COMPARATOR | Ensifentrine monotherapy 3 mg |
| Treatment Arm F: Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Ensifentrine | DRUG | Dosage Formulation: Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily for 24 weeks or 48 weeks |
| Placebo | DRUG | Dosage Formulation: Ensifentrine Placebo Nebulizer solution Frequency: Twice Daily for 24 weeks or 48 weeks |
| Ensifentrine 3 mg | DRUG | Single dose, administered by oral inhalation using a standard jet nebulizer |
| Glycopyrrolate 42.5 mcg | DRUG | Single dose, administered by oral inhalation using a standard jet nebulizer |
| Ensifentrine 1.5 mg | DRUG | Single dose, administered by oral inhalation using a standard jet nebulizer |
| Ensifentrine 3 mg (marketed formulation) | DRUG | Single dose, administered by oral inhalation using a standard jet nebulizer |
| Glycopyrrolate 21.25 mcg | DRUG | Administered by a standard jet nebulizer, twice daily for 28 consecutive days |
Inclusion Criteria: Informed Consent 1. Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form (ICF). Age and Sex 2. Age: Patient must be 40 ...