BI443651 methacholine challenge in asthmatic patients
Research type
Research Study
Full title
A two part phase I, multiple-dose, single- and double-blind randomised, double-dummy, placebo-controlled, four-way crossover study to assess safety and tolerability of BI 443651 via Respimat® versus placebo via Respimat® in subjects with mild asthma following methacholine challenge.
IRAS ID
225472
Contact name
Jill Paterson
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2016-001506-42
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
This trial compares the effects of BI443651 with placebo. BI443651 is a medication designed to treat COPD and Cystic Fibrosis. This is the third time that BI 443651 will be given to males and the second time that BI 443651 will be given to females. In this trial, BI443651 will be tested in subjects with asthma to gain a deeper understanding of how it effects respiratory conditions.\n\nThe study will involve methacholine challenges which are a test used to measure a persons airway sensitivity and are a useful tool to learn more about the lungs. In this study, BI443651 will only be tested in subjects with asthma. Women of child bearing potential will not be enrolled.\n\nThe trial is split into two parts; Part 1 (Pilot) and Part 2 (Main). Subjects will complete either part 1 or 2, not both.\n\nPart 1- This part will only take place after sufficient data from another study (protocol 1363.2) is available. Four participants will enter Part 1. Participants in Part 1 will receive 4 different doses of medication, Placebo, 100μg, 400μg and 1200μg.\n\n\nPart 2- This part will involve 32 subjects and will only take place after Part 1 has been completed. Part 2 involves the same dose levels as Part 1 however the doses may be given in a random order.\n\nThe study will involve procedures such as blood/urine samples, spirometry tests as well as medical examinations. \n\nParticipation in the trial will last a maximum of 134 days, including 4 overnight stays during each of the treatment periods. The treatments periods for both parts are identical.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0216
Date of REC Opinion
16 May 2017
REC opinion
Further Information Favourable Opinion