NEW TREATMENT

1 . A method of treating moderate chronic obstructive pulmonary disease (COPD) in a human subject in need thereof, the method comprising administering to the human subject via inhalation two or more doses of a composition comprising a therapeutically effective amount of ensifentrine or a pharmaceutically acceptable salt thereof, wherein moderate COPD comprises a FEV 1 /FVC<0.7 and 50%≤FEV 1 <80% predicted FEV 1 value, wherein FEV 1 is forced expiratory volume in one second, and wherein FVC is forced vital capacity each as measured from 15 to 30 minutes following administration of a bronchodilator to the human subject, and wherein the method increases average FEV1 of the human subject by at least 90 mL 12 weeks following the administering to the human subject.

2 . The method of claim 1 , wherein the method increases average FEV 1 of the human subject by at least 100 mL 12 weeks following the administering to the human subject.

3 . The method of claim 1 , wherein the administering to the human subject is twice per day in a first dose and a second dose.

4 . The method of claim 3 , wherein the first dose and the second dose are administered to the human subject in equal amounts.

5 . The method of claim 3 , wherein the first dose is administered to the human subject in the morning and the second dose is administered to the human subject in the evening.

6 . The method of claim 3 , wherein the first dose is administered within three hours after the human subject waking, and the second dose is administered within three hours before the human subject sleeps.

7 . The method of claim 3 , wherein the first dose and the second dose are administered from 10 to 14 hours apart.

8 . The method of claim 3 , wherein the therapeutically effective amount of the ensifentrine or the pharmaceutically acceptable salt thereof is 2 mg to 4 mg.

9 . The method of claim 8 , wherein the therapeutically effective amount of the ensifentrine or the pharmaceutically acceptable salt thereof is 3 mg.

10 . The method of claim 1 , wherein the composition is a suspension.

11 . The method of claim 10 , wherein the suspension comprises particles, wherein the particles comprise at least 90 weight percent ensifentrine relative to total weight of the particles.

12 . The method of claim 10 , wherein the suspension comprises particles, wherein the particles comprise at least 99 weight percent ensifentrine relative to total weight of the particles.

13 . The method of claim 10 , wherein the suspension comprises 3 mg ensifentrine free base.

14 . The method of claim 10 , wherein the suspension comprises particles, wherein the particles have a particle size distribution with a Dv50 of from 0.5 μm to 5 μm.

15 . The method of claim 10 , wherein the suspension comprises particles, wherein the particles have a particle size distribution with a Dv50 of from 1 μm to 2 μm.

16 . The method of claim 10 , wherein the suspension comprises:

a. ensifentrine particles at a concentration of from 1 to 1.4 mg/mL;

b. polysorbate 20 (Tween 20) at a concentration of from 0.3 to 0.7 mg/mL;

c. sorbitan monolaurate (Span 20) at a concentration of from 0 to 0.1 mg/mL;

d. sodium dihydrogen phosphate dihydrate at a concentration of from 0.5 to 1 mg/mL;

e. disodium hydrogen phosphate dihydrate at a concentration of from 0.5 to 1 mg/mL;

f. sodium chloride at a concentration of from 5 to 10 mg/mL; and

g. water.

17 . The method of claim 10 , wherein the suspension comprises:

a. 1.2 mg/ml ensifentrine;

b. 0.5 mg/ml polysorbate 20;

c. 0.05 mg/ml sorbitan monolaurate;

d. 0.744 mg/ml sodium dihydrogen phosphate dihydrate;

e. 0.853 mg/ml disodium hydrogen phosphate dihydrate;

f. 8.6 mg/ml sodium chloride; and

g. water.

18 . The method of claim 1 , wherein the method further comprises administering to the human subject a muscarinic receptor antagonist, a beta-adrenergic receptor agonist, an inhaled corticosteroid, or a combination thereof.

19 . The method of claim 18 , wherein the muscarinic receptor agonist is a long-acting muscarinic receptor antagonist (LAMA).

20 . The method of claim 18 , wherein the LAMA is aclidinium, darotropium, tiotropium, glycopyrrolate, or umeclidinium.

21 . The method of claim 18 , wherein the beta-adrenergic receptor agonist is a long-acting beta-adrenergic receptor agonist (LABA).

22 . The method of claim 21 , wherein the LABA is salmeterol, formoterol, indacaterol, vilanterol, olodaterol, abediterol or carmoterol.

23 . The method of claim 18 , wherein the inhaled corticosteroid is beclomethosone, budesonide, fluticasone propionate, ciclesonide, mometasone, or fluticasone furoate.

24 . The method of claim 1 , wherein the bronchodilator is salbutamol.

25 . The method of claim 1 , wherein the composition is administered via a nebulizer.

26 . The method of claim 1 , wherein the composition is administered via a dry powder inhaler (DPI).

27 . The method of claim 1 , wherein the composition is administered via a pressurized metered dose inhaler (pMDI).