Phase I Study of Alpha-1 Proteinase Inhibitor in Cystic Fibrosis
Research type
Research Study
Full title
A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Phase I Study of the Safety and Tolerability of Alpha-1-Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects with Cystic Fibrosis
IRAS ID
71062
Contact name
Thomas Daniels
Sponsor organisation
CSL Behring GmbH
Eudract number
2010-022671-60
ISRCTN Number
finished
Research summary
This clinical trial aims to investigate a product, A1-PI (H)inhalation solution (also called CR002), that's being developed by the company CSL Behring. The active ingredient is a protein extracted from the plasma of human blood. A1-PI (H) is being developed for the purposes of treating the lung damage associated with excessive inflammation that's seen in cystic fibrosis (CF) (also known as mucoviscidosis). This is the first study designed to assess the safety and tolerability of A1 PI(H) inhalation solution in people with cystic fibrosis (CF). Additionally, this study will assess the ability for people to correctly operate the I-neb© drug delivery device in either the Target Inhalation Mode (TIM) or the Tidal Breathing Mode (TBM).This study that will take place at approximately 10 centers in Europe. Approximately 24 people with cystic fibrosis will be in the study, with each participant involved for up to 44 days.Participants will be required to meet eligibility criteria in order to participate in the study, and will be required to undergo study procedures that include physical examination, breath analysis for nitric oxide, 12 lead electrocardiogram, pulmonary function test and blood draws for laboratory tests. Eligible subjects will be randomly assigned to receive a single dose of A1 PI(H) inhalation solution at 77 mg, 175 mg or 350 mg, or a single dose of placebo.
REC name
East of England - Essex Research Ethics Committee
REC reference
11/EE/0088
Date of REC Opinion
6 May 2011
REC opinion
Further Information Favourable Opinion