Ignite Creation Date:
2024-05-06 @ 1:57 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01939587
Status:
COMPLETED
Last Update Posted:
2016-03-08
First Post:
2013-08-08
Brief Title:
Study to Assess the Efficacy of a Single PBF-680 Oral Administration to Attenuate Adenosine 5-Monophosphate Challenge-induced Airway Hyperresponsiveness in Mild-to-moderate Asthmatics
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
A Single-centre Randomised Double-blind Placebo-controlled 3-way Multiple Dose Cross-over Proof-of-concept Study to Assess the Efficacy of a Single PBF-680 Oral Administration to Attenuate Adenosine 5-Monophosphate AMP Challenge-induced Airway Hyperresponsiveness in Mild-to-moderate Asthmatics
Status:
COMPLETED
Status Verified Date:
2016-03
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 single-center double-blind randomized trial utilizing a three-period balanced block design with each period comprising a unique study product administration The treatments studied are PBF-680 5 mg PBF-680 20 mg and placebo as an orally administered capsule The study includes a screening visit a selection visit three visits for the randomized treatment sequence and an end-of-study follow-up visit spanning through a 65-day maximum study duration The study will be conducted on 18 male or female adults aged ³18 years with a diagnosis of stable mild to moderate asthma as per GINA guidelines with no smoking or less than a 5 packs-years smoking history history responsive to AMP airway challenge as determined in the selection visit
The primary efficacy variable will be the PC20 yielded from AMP airway challenge testing at the three treatment visits FeNO sampled at three time points at each treatment period visit will be a exploratory variable Safety assessment will include monitoring of adverse events physical examination vital signs EKGs spirometry serum and urine pregnancy tests and laboratory determinations Blood sampling at a time-point series will provide pharmacokinetics data
The primary variable of the study is PC20 mgmL-1 The PC 20 distributions will be analyzed by treatment using ANOVA for repeated measurements followed by post hoc pairwise comparisons as appropriate Other analyses will comprise FeNO pharmacokinetics data sets generated from baseline characteristics and safety assessments and discretionary expiratory analyses to evaluate the influence of baseline and clinical covariates on the primary variable
The primary efficacy variable will be the PC20 yielded from AMP airway challenge testing at the three treatment visits FeNO sampled at three time points at each treatment period visit will be a exploratory variable Safety assessment will include monitoring of adverse events physical examination vital signs EKGs spirometry serum and urine pregnancy tests and laboratory determinations Blood sampling at a time-point series will provide pharmacokinetics data
The primary variable of the study is PC20 mgmL-1 The PC 20 distributions will be analyzed by treatment using ANOVA for repeated measurements followed by post hoc pairwise comparisons as appropriate Other analyses will comprise FeNO pharmacokinetics data sets generated from baseline characteristics and safety assessments and discretionary expiratory analyses to evaluate the influence of baseline and clinical covariates on the primary variable
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-002906-30 | EUDRACT_NUMBER | None | None |