Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759807
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2021-02-01
Brief Title:
A Phase 1b Study of PUR1800 in Patients With COPD
Sponsor:
Pulmatrix Inc
Organization:
Pulmatrix Inc
Study Overview
Official Title:
A Phase 1b 3-way Crossover Study to Assess the Safety Tolerability and Pharmacokinetics of Repeated Once Daily Doses of PUR1800 in Adult Patients With Stable Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2022-06
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:
None
Brief Summary:
This is a randomised placebo-controlled double-blind 3-way crossover study in which PUR1800 or placebo is dosed daily for 14 consecutive days in adult subjects with stable COPD over three discrete TPs Subjects will be randomised to one of the following 3 treatment sequences
Sequence Period 1 Period 2 Period 3
1 Placebo PUR1800 250 μg PUR1800 500 μg
2 PUR1800 250 μg Placebo PUR1800 500 μg
3 PUR1800 250 μg PUR1800 500 μg Placebo
Since this is the first study in humans in which the iSPERSE formulation is being administered the 3 treatment sequences are designed in order to ensure that the lower dose of PUR1800 250 μg is administered prior to the administration of the higher dose of PUR1800 500 μg
Sequence Period 1 Period 2 Period 3
1 Placebo PUR1800 250 μg PUR1800 500 μg
2 PUR1800 250 μg Placebo PUR1800 500 μg
3 PUR1800 250 μg PUR1800 500 μg Placebo
Since this is the first study in humans in which the iSPERSE formulation is being administered the 3 treatment sequences are designed in order to ensure that the lower dose of PUR1800 250 μg is administered prior to the administration of the higher dose of PUR1800 500 μg
Detailed Description:
The study design is as follows
Informed Consent Before any study specific procedures are conducted or study requirements are expected of a patient the patient must review and sign an IEC-approved informed consent form
Screening Subjects will be screened for eligibility to participate in the study within 28 days before randomisation ie TP1 Day 1
Treatment Periods
Period 1 On Day 1 all subjects who are eligible for entry into the study will be randomised to 1 of 3 treatment sequences and receive either placebo or the lowest nominal dose of PUR1800 PUR1800 250 μg for 14 consecutive days
Period 2 Following a washout period of at least 28 days after the completion of Period 1 dosing subjects will receive a treatment other than what the subject received during Period 1 for 14 consecutive days
Period 3 Following a washout period of at least 28 days after the completion of Period 2 dosing subjects will receive the treatment that the subject had not received during Periods 1 or 2 either placebo or PUR1800 500 μg for 14 consecutive days
End of Study EOS Subjects will return to the study site 28 days after the last dose of the last TP or in the event of early withdrawal after the last dose received if possible for an EOS visit Unscheduled visits are permitted at the discretion of the investigator
Informed Consent Before any study specific procedures are conducted or study requirements are expected of a patient the patient must review and sign an IEC-approved informed consent form
Screening Subjects will be screened for eligibility to participate in the study within 28 days before randomisation ie TP1 Day 1
Treatment Periods
Period 1 On Day 1 all subjects who are eligible for entry into the study will be randomised to 1 of 3 treatment sequences and receive either placebo or the lowest nominal dose of PUR1800 PUR1800 250 μg for 14 consecutive days
Period 2 Following a washout period of at least 28 days after the completion of Period 1 dosing subjects will receive a treatment other than what the subject received during Period 1 for 14 consecutive days
Period 3 Following a washout period of at least 28 days after the completion of Period 2 dosing subjects will receive the treatment that the subject had not received during Periods 1 or 2 either placebo or PUR1800 500 μg for 14 consecutive days
End of Study EOS Subjects will return to the study site 28 days after the last dose of the last TP or in the event of early withdrawal after the last dose received if possible for an EOS visit Unscheduled visits are permitted at the discretion of the investigator
Study Oversight
Has Oversight DMC:
None
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?:
None