A clinical trial to assess the effect of PBF-680 in patients with moderate to severe Chronic Obstructive Pulmonar Disease on top of standard medication.
- Conditions
- Patients with moderate to severe Chronic Obstructive Pulmonar Disease (COPD)MedDRA version: 21.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-001732-25-ES
- Lead Sponsor
- Palobiofarma, S.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 102
1.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.
2.Male or female aged between 40 and 80 years inclusive, at the time of informed consent.
3.If male: unless surgically sterile, must agree to meet the following from the first dose up to the Follow-up, 2 weeks after the last dose of study medication:
•Not donate sperm
•Either: be sexually abstinent in accordance with a patient's usual and preferred lifestyle (but agree to abide by the contraception requirements below should their circumstances change)
Or: use a condom with all sexual partners. If the partner is a female of childbearing potential the condom must be used with spermicide and a second reliable form of contraception must also be used (e.g. diaphragm/cap with spermicide, established hormonal contraception, intra-uterine device)
If female: be of non-childbearing potential, or use a highly effective form of contraception as defined in Appendix I. Female patients of childbearing potential must use this contraceptive from first dose until the Follow-up (2 weeks after final dose) and have a negative pregnancy test at Visit 1 and Visit 2 prior to randomization.
4.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).
5.Capable of complying with all study restrictions and procedures.
6.Body mass index (BMI) between 20 and 35 kg/m2 (inclusive)
7.COPD diagnosis: Patients with a clinical diagnosis of COPD as defined by Global Initiative for Chronic Obstructive Lung Disease – GOLD 2020 with symptoms compatible with COPD for at least 1 year prior to screening (Visit 1).
8.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.
9.Patient with blood eosinophils >100 cells/µL
10.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.
11.Clinically stable COPD in the 4 weeks prior to screening (Visit 1) and randomization (Visit 2).
12.Meet the concomitant medication restrictions and be expected to do so for the rest of the study.
13.Current and former smokers with a smoking history of = 10 pack years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 102
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.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.
2.Participants with a significant COVID-19 illness = OMS-4 within 6 months of enrolment
3.A history of life-threatening COPD including Intensive Care Unit admission and requiring intubation.
4.COPD exacerbation requiring oral steroids in the 3 months prior to randomization (Visit 2).
5.A history of one or more hospitalizations for COPD in the 3 months prior to screening (Visit 1).
6.Lower respiratory tract infection treated with antibiotics within 1 month of randomization (Visit 2).
7.Increased pre-BD FEV1 at randomization visit (V2) compared to Screening (V1) of = 400 mL or = 20% of V1 FEV1.
8.Evidence of cor pulmonale or clinically significant pulmonary hypertension.
9.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.
10.Previous lung resection or lung reduction surgery.
11.Oral therapies for COPD (e.g., theophylline, and roflumilast) in 1 month prior to screening (Visit 1) and throughout the study.
12.Pulmonary rehabilitation, unless such treatment has been stable for 4 weeks prior to Visit 1) and remains stable during the trial.
13.A history of, or reason to believe a subject has, drug or alcohol abuse within the past 3 years.
14.Received an experimental drug within 30 days or five half-lives of Visit 2, whichever is longer.
15.Women who are pregnant or breast-feeding.
16.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.
17.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.
18.Major surgery (requiring general anesthesia) in the 6 weeks prior to screening (Visit 1), lack of full recovery from surgery at screening (Visit 1), or planned surgery through the end of the study.
19.History of malignancy of any organ system within 5 years, with the exception of localized skin cancers (basal or squamous cell).
20.Clinically significant abnormal values for safety laboratory tests (hematology, biochemistry, or urinalysis) at screening, as determined by the Investigator.
21.Treatment with oxygen of more than 12 hours per day.
22.Any other reason that the Investigator considers makes the subject unsuitable to participate.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method