Therapeutic Effect of PBF-680 in Patients With COPD

NCT05262218 | Completed Phase 2

• 1 other identifier: PBF680CT-06
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 7

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 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

COPD

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the blood eosinophil count

  Absolute and relative change from baseline (pre-dose ) will be computed. Mean difference will be provided.

  28 days

Secondary Outcomes (8)

• Effect of PBF-680 on trough forced expiratory volume in 1 second (FEV1)

  28 days

• Change from baseline in prebronchodilator FEV1 at 3h post administration

  28 days

• Change from baseline in postbronchodilator FEV1 at 3h post administration

  28 days

• Change from baseline in the StGeorge's Respiratory Questionnaire (SGRQ-C)

  28 days

• Change from baseline in the Baseline Dyspnea Index (BDI)/ Transition Dyspnea Index (TDI) (BDI/TDI)

  28 days

Study Arms (2)

PBF-680

EXPERIMENTAL

PBF-680 is an Adenosine A1 receptor antagonist formulated in oral gelatine capsules

Drug: PBF-680 10mg

Placebo

PLACEBO COMPARATOR

Placebo formulated in oral gelatine capsules

Drug: Placebo

Interventions

PBF-680 10mg DRUG

PBF-680 10mg administered orally once a day

PBF-680

Placebo DRUG

Placebo administered orally once a day

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Palobiofarma SL: lead
• Scope International AG: collaborator

Study Sites (7)

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Location

Hospital Bellvitge

Barcelona, Spain

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital German Trias i Pujol

Barcelona, Spain

Location

Hospital Sant Pau

Barcelona, Spain

Location

Hospital Vall d´hebron

Barcelona, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nahomi Castro Palomino, PhD

  Palobiofarma S.L

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 2, 2022
• Study Start: December 20, 2021
• Primary Completion: February 27, 2024
• Study Completion: April 9, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)