Therapeutic Effect of PBF-680 in Patients With COPD
NCT05262218 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174
Last updated 2024-04-19
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.
Conditions
Interventions
- DRUG
-
PBF-680 10mg
PBF-680 10mg administered orally once a day
- DRUG
-
Placebo administered orally once a day
Sponsors & Collaborators
-
Scope International AG
collaborator INDUSTRY -
Palobiofarma SL
lead INDUSTRY
Principal Investigators
-
Nahomi Castro Palomino, PhD · Palobiofarma S.L
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-20
- Primary Completion
- 2024-02-27
- Completion
- 2024-04-09
Countries
- Spain
Study Locations
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