COPDPhase 2RespireNCT05262218
Therapeutic Effect of PBF-680 in Patients With COPD
A Phase 2 study testing PBF-680 10mg in people with COPD, run by Palobiofarma SL at 7 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- PBF-680 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 7 sitesSpain
- Study dates
- 20 Dec 2021to 9 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Bellvitge
Barcelona
Hospital Clinic
Barcelona
Hospital del Mar
Barcelona
Hospital German Trias i Pujol
Barcelona
Hospital Sant Pau
Barcelona
Hospital Vall d´hebron
Barcelona
Complejo Hospitalario de Navarra
Pamplona, Navarre
About this study
Official title: A Phase IIa, Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of PBF-680 in Patients With Moderate to Severe COPD on Top of the Standard Medication
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.
Read the 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 severe COPD over 4 weeks on top of the standard medication. It is planned to enroll approximately 114 patients at 8 sites with a target of 102 participants completing 4 weeks of treatment and key study assessments. The study comprises 5 visits: screening (Visit 1), randomization (Visit 2), 15 days-treatment visit (Visit 3), end of study visit (Visit 4) and follow up visit (visit 5).
Patients will be screened for eligibility (Visit 1). After the screening visit, patients will be instructed to continue at the same COPD standard medication (long-acting bronchodilators (long acting beta2-agonists [LABA] and/or long-acting muscarinic antagonists [LAMA]) and inhaled corticosteroids. Albuterol/salbutamol may be used as needed but must be held for at least 8 hours before a study visit.
Eligible patients will then return for Visit 2. The pre-dose FEV1 must be within 20% and 400ml of the predose FEV1 at the screening visit. Patients will be assessed for inclusion into the study, and if appropriate will be randomized to one of the two treatment arms. They will receive the first dose of study medication (PBF-680 or placebo) in the clinic (morning on fasting conditions) and have 3 spirometry performed in a timeframe of 3 hours. Patients will be discharged from the clinic, having been instructed to use the study medication on a once-a-day basis and in fasting conditions. The subject must record in a diary the daily self-administration of the study medication. The patient's diary will be provided together with the medication package dispensed on visit V2. The subject must be instructed to bring the medication package with all blisters to the site on visits V3 and V4.
Patients will return for 1 interim visit (Visit 3). At this visit, patients will bring the study medication pack containing the empty blisters and unused study medication. The dose of the study medication will be administered in the clinic. Spirometries will be performed at predose and 3h hour post dose.
At the final study visit (Visit 4), patients will be resident at the study center from the morning until at least 3 hours after dosing to allow for monitoring of lung function and study closeout procedures.
A follow-up visit (Visit 5) will occur 2 weeks after the final study visit as a safety follow-up.
- Conditions
- COPD
- Being tested
- PBF-680 10mg, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBF-680 10mgDrug
PBF-680 10mg administered orally once a day
PlaceboDrug
Placebo administered orally once a day
| Study group | Role | What they receive |
|---|---|---|
| PBF-680 | Experimental | PBF-680 is an Adenosine A1 receptor antagonist formulated in oral gelatine capsules Receives: Drug: PBF-680 10mg |
| Placebo | Placebo comparator | Placebo formulated in oral gelatine capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the blood eosinophil count
Absolute and relative change from baseline (pre-dose ) will be computed. Mean difference will be provided.
Measured: 28 days
Secondary outcomes (8)
Effect of PBF-680 on trough forced expiratory volume in 1 second (FEV1)
Measured: 28 days
Change from baseline in prebronchodilator FEV1 at 3h post administration
Measured: 28 days
Change from baseline in postbronchodilator FEV1 at 3h post administration
Measured: 28 days
Change from baseline in the StGeorge's Respiratory Questionnaire (SGRQ-C)
St George's Respiratory Questionnaire Questionnaire is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. it is of 50 items questionnaire divided in two parts Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 28 days
Change from baseline in the Baseline Dyspnea Index (BDI)/ Transition Dyspnea Index (TDI) (BDI/TDI)
The Baseline Dyspnea Index is scored from 0 to 12 and is only assessed at baseline. The lower the score the worse the dyspnea severity. The Transition Dyspnea Index measures the change in dyspnea severity from the baseline as measured by the Baseline Dyspnea Index. It is rated by seven grades ranging from -3 (major deterioration) to +3 (major improvement).
Measured: 28 days
Change from baseline in the COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) is questionnaire assessing globally the impact of COPD (cough, sputum, dysnea, chest tighteness) on health status. Number of items: 8 (one question assessing impact on sleep). Scaling of items:1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. No target score represents the best achievable outcome.
Measured: 28 Days
Change from baseline in the Modified Medical Research Council (MRC) breathlessness scales.
The Modified Medical Research Council(MRC) uses a simple grading system to assess a patient's level of breathlessness. It is rated by 4 grades ranging from 0 (best condition) to 4 (worse condition)
Measured: 28 days
Number of subjects with treatment-related adverse events as assessed by CTCAE v4
Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start20 Dec 2021
- Primary completion27 Feb 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palobiofarma SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scope International AG
- Responsible party
- Sponsor
- Investigators
- Nahomi Castro Palomino, PhD, Study chair, Palobiofarma S.L
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262218
- Sponsor's protocol ID
- PBF680CT-06
- Acronym
- Respire
- Status last verified
- Apr 2024
- First submitted
- 17 Feb 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double Blind, Placebo Controlled Study to Assess the Effect of PBF-680 in Patients With Moderate to Severe COPD on Top of the Standard Medication
- ClinicalTrials.gov ID
- NCT05262218
- Acronym / sponsor ID
- Respire / PBF680CT-06
- Conditions
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Palobiofarma SLIndustry (pharma, biotech, devices)
- Collaborators
- Scope International AG
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 severe COPD over 4 weeks on top of the standard medication. It is planned to enroll approximately 114 patients at 8 sites with a target of 102 participants completing 4 weeks of treatment and key study assessments. The study comprises 5 visits: screening (Visit 1), randomization (Visit 2), 15 days-treatment visit (Visit 3), end of study visit (Visit 4) and follow up visit (visit 5).
Patients will be screened for eligibility (Visit 1). After the screening visit, patients will be instructed to continue at the same COPD standard medication (long-acting bronchodilators (long acting beta2-agonists [LABA] and/or long-acting muscarinic antagonists [LAMA]) and inhaled corticosteroids. Albuterol/salbutamol may be used as needed but must be held for at least 8 hours before a study visit.
Eligible patients will then return for Visit 2. The pre-dose FEV1 must be within 20% and 400ml of the predose FEV1 at the screening visit. Patients will be assessed for inclusion into the study, and if appropriate will be randomized to one of the two treatment arms. They will receive the first dose of study medication (PBF-680 or placebo) in the clinic (morning on fasting conditions) and have 3 spirometry performed in a timeframe of 3 hours. Patients will be discharged from the clinic, having been instructed to use the study medication on a once-a-day basis and in fasting conditions. The subject must record in a diary the daily self-administration of the study medication. The patient's diary will be provided together with the medication package dispensed on visit V2. The subject must be instructed to bring the medication package with all blisters to the site on visits V3 and V4.
Patients will return for 1 interim visit (Visit 3). At this visit, patients will bring the study medication pack containing the empty blisters and unused study medication. The dose of the study medication will be administered in the clinic. Spirometries will be performed at predose and 3h hour post dose.
At the final study visit (Visit 4), patients will be resident at the study center from the morning until at least 3 hours after dosing to allow for monitoring of lung function and study closeout procedures.
A follow-up visit (Visit 5) will occur 2 weeks after the final study visit as a safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBF-680 | Experimental | Drug: PBF-680 10mgPBF-680 is an Adenosine A1 receptor antagonist formulated in oral gelatine capsules |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo formulated in oral gelatine capsules |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBF-680 10mgPBF-680 10mg administered orally once a day | Drug | PBF-680 |
| PlaceboPlacebo administered orally once a day | Drug | Placebo |
Primary outcome
Change from baseline in the blood eosinophil count
Time frame: 28 days
Absolute and relative change from baseline (pre-dose ) will be computed. Mean difference will be provided.
8 secondary outcomes
Effect of PBF-680 on trough forced expiratory volume in 1 second (FEV1)
Time frame: 28 days
Change from baseline in prebronchodilator FEV1 at 3h post administration
Time frame: 28 days
Change from baseline in postbronchodilator FEV1 at 3h post administration
Time frame: 28 days
Change from baseline in the StGeorge's Respiratory Questionnaire (SGRQ-C)
Time frame: 28 days
Change from baseline in the Baseline Dyspnea Index (BDI)/ Transition Dyspnea Index (TDI) (BDI/TDI)
Time frame: 28 days
Change from baseline in the COPD Assessment Test (CAT)
Time frame: 28 Days
Change from baseline in the Modified Medical Research Council (MRC) breathlessness scales.
Time frame: 28 days
Number of subjects with treatment-related adverse events as assessed by CTCAE v4
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nahomi Castro Palomino, PhD study chair
Palobiofarma S.L
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PBF-680 10mg in people with COPD, run by Palobiofarma SL at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the blood eosinophil count (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.