A Phase IIa, Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of PBF-680 in Patients With Moderate to Severe COPD on Top of the Standard Medication
The purpose of the study is to investigate the effect of PBF-680 on the chronic inflammation and the lung function of patients with COPD on top of the standard medication. The effects of PBF-680 administration will also be examined with regards to symptom improvement and safety measures.One oral dose of PBF-680 or placebo will be administered daily for 4 weeks after randomization. The treatments will be administered double-blind with the Investigator and patient unaware of the treatment identity. A total of 102 COPD patients, either male or female, aged 40 to 80 years (inclusive) will be randomized.
A phase IIa, randomized, double blind, placebo-controlled study to assess the effect of PBF-680 in patients with moderate to severe COPD on top of standard medication.
开始日期2021-08-13
申办/合作机构-
NCT03774290
/ Completed临床2期
A Phase II, Double-blind, Randomized, Parallel-group, Placebo- Controlled Multi-center Study to Investigate the Effect of the Adenosine A1 Receptor Antagonist PBF-680 on Forced Expiratory Volume in 1 Second (FEV1) in Patients With Mild-to-moderate Persistent Atopic Asthma
The present trial is an exploratory study aiming at evaluating the safety, tolerability, and efficacy of a 15-day, once daily administration of 10 mg PBF-680 in subjects with persistent, mild-to-moderate atopic asthma.