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
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|ClinicalTrials.gov Identifier: NCT01939587|
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : March 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: PBF-680 5 mg Drug: PBF-680 20 mg Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: PBF-680 5 mg
5 mg of PBF-680
Drug: PBF-680 5 mg
Experimental: PBF-680 20 mg
20 mg of PBF-680
Drug: PBF-680 20 mg
Placebo Comparator: Placebo
- Change in PC20 yielded from AMP airway challenge testing [ Time Frame: 2.25, 3.5, 8 hours post dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939587
|Palobiofarma S.L. (molecule owner)|
|Mataró, Barcelona, Spain, 08302|
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|