drugset / Trial / NCT05262218

Therapeutic Effect of PBF-680 in Patients With COPD

NCT05262218 ↗

Phase 2 Completed 174 enrolled Palobiofarma SL Scope International AG · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2021-12-20
Primary completion
2024-02-27
Completion
2024-04-09

Outcome

Met primary endpoint

release “The clinical study met its primary endpoint, with PBF-680 10 mg once daily demonstrating a statistically significant reduction in blood eosinophil count” palobiofarma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject PBF-680 Unknown 10 mg Oral