Asthma Clinical Trial
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
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, mg×mL-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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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