New inhaler for COPD shows promise in early trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able and willing to provide written informed consent and to comply with the study protocol; 2. Subjects 40 years of age or older (inclusive), Male or female subjects; 3. Subjects with an established clinical history of COPD; 4. A post-bronchodilator FEV1/FVC ratio must be \<0.7 at Screening and FEV1 must be \<80% and ≥30% predicted normal at pre-randomization; 5. a documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbation in the previous 12 months; 6. Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking; 7. A score of ≥10 on the COPD Assessment Test (CAT) at pre-randomization. Exclusion Criteria: 1. Subjects who required systemic corticosteroids or antibiotics or hospitalized due to poorly controlled COPD or who had lower respiratory tract infections that required antibiotics within 4 weeks prior to Screening to pre-randomization; 2. Subjects who had respiratory tract infections that required antibiotics within 2 weeks prior to Screening to pre-randomization; 3. Subjects with other respiratory or respiratory related diseases, including but not limited to asthma, active tuberculosis, lung cancer, interstitial pulmonary disease, α1-antitrypsin deficiency, pulmonary heart disease, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary disease; 4. Subjects with lung volume reduction surgery within the 12 months prior to Screening; 5. Subjects who have Other known serious medical conditions； 6. Subjects receiving oxygen therapy required for greater than 15 hours a day; 7. Clinically significant electrocardiogram abnormality； 8. Subjects with significant laboratory abnormality at screening； 9. Suspected allergy to any ingredient in the study drug; 10. Participation in clinical trials of any drug or medical device (except for screening failures) within 4 weeks before screening, or within 5 half-lives of the drug at screening (whichever is longer); 11. Pregnant or lactating females; 12. History of drug abuse within one year before screening 13. Other conditions judged by the investigator to be not suitable to participate in the trial.