Therapeutic Effect of PBF-680 in Patients With COPD

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Palobiofarma SL
• Collaborator: SCOPE International AG

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.