Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT05262218
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2022-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Effect of PBF-680 in Patients With COPD
Sponsor:
Palobiofarma SL
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Respire
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: