Status:
COMPLETED
Therapeutic Effect of PBF-680 in Patients With COPD
Lead Sponsor:
Palobiofarma SL
Collaborating Sponsors:
Scope International AG
Conditions:
COPD
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief 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 admin...
Detailed Description
This is a Phase IIa, randomized, double-blind, placebo-controlled, parallel-group study to investigate the effect of the oral adenosine A1 receptor antagonist PBF-680 in patients with moderate to seve...
Eligibility Criteria
Inclusion
- Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Male or female aged between 40 and 80 years inclusive, at the time of informed consent.
- Have a 12-lead ECG recording at screening (Visit 1) showing the following (and no changes at Visit 2 deemed clinically significant by the Investigator):
- Heart rate between 50 and 90 beats per minute QT interval corrected for heart rate using Fridericia's formula (QTcF) interval ≤ 450 msec for males and ≤ 470 msec for females. QRS complex ≤ 120 msec PR interval ≤ 200 msec
- No clinically significant abnormality including morphology (e.g. left bundle branch block, atrioventricular nodal dysfunction, ST segment abnormality consistent with ischemia).
- Capable of complying with all study restrictions and procedures.
- Body mass index (BMI) between 20 and 35 kg/m2 (inclusive)
- COPD diagnosis: Patients with a clinical diagnosis of COPD as defined by Global Initiative for Chronic Obstructive Lung Disease - GOLD 20201 with symptoms compatible with COPD for at least 1 year prior to screening (Visit 1).
- Background triple therapy (ICS + LABA + LAMA) or double therapy (ICS + LABA or ICS + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to Visit 1.
- Patient with blood eosinophils \>100 cells/µL
- Ability to perform acceptable and reproducible spirometry. Post- bronchodilator (albuterol/salbutamol four puffs) spirometry at screening (Visit 1) must demonstrate a:
- Post-bronchodilator FEV1/FVC ratio ≤ 0.70 Post-bronchodilator FEV1 ≥ 30 % and: ≤ 75 % of predicted normal.
- Clinically stable COPD in the 4 weeks prior to screening (Visit 1) and randomization (Visit 2).
- Meet the concomitant medication restrictions and be expected to do so for the rest of the study.
- Current and former smokers with a smoking history of ≥ 10 pack years.
Exclusion
- Participants who have not been Vaccinated against SARS-CoV-2 and after performing a diagnostic nucleic acid test at screening visit, this would produce a positive result
- Participants with a significant COVID-19 illness ≥ OMS-4 within 6 months of enrolment
- A history of life-threatening COPD including Intensive Care Unit admission and requiring intubation.
- COPD exacerbation requiring oral steroids in the 3 months prior to randomization (Visit 2).
- A history of one or more hospitalizations for COPD in the 3 months prior to screening (Visit 1).
- Lower respiratory tract infection treated with antibiotics within 1 months of randomization (Visit 2).
- Increased pre-BD FEV1 at randomization visit (V2) compared to Screening (V1) of ≥ 400 mL or ≥ 20% of V1 FEV1.
- Evidence of cor pulmonale or clinically significant pulmonary hypertension.
- Other respiratory disorders: Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, known alpha-1 antitrypsin deficiency or other active pulmonary diseases.
- Previous lung resection or lung reduction surgery.
- Oral therapies for COPD (e.g., theophylline, and roflumilast) in 1 month prior to screening (Visit 1) and throughout the study.
- Pulmonary rehabilitation, unless such treatment has been stable for 4 weeks prior to Visit 1) and remains stable during the trial.
- A history of, or reason to believe a subject has, drug or alcohol abuse within the past 3 years.
- Received an experimental drug within 30 days or five half-lives of Visit 2, whichever is longer.
- Women who are pregnant or breast-feeding.
- Patients with a history of chronic uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant.
- Documented cardiovascular disease: arrhythmias, unstable angina, recent or suspected myocardial infarction within 6 months prior to screening, congestive heart failure, a history of unstable or uncontrolled hypertension, or has been diagnosed with hypertension in last 3 months.
Key Trial Info
Start Date :
December 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2024
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT05262218
Start Date
December 20 2021
End Date
April 9 2024
Last Update
April 19 2024
Active Locations (7)
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1
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
2
Hospital Bellvitge
Barcelona, Spain
3
Hospital Clinic
Barcelona, Spain
4
Hospital del Mar
Barcelona, Spain