The effects of multiple doses of QBM076 in COPD patients
Research type
Research Study
Full title
A two part, double blind, placebo controlled, study to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of multiple doses of QBM076 in patients with COPD.
IRAS ID
137290
Contact name
Dave Singh
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Eudract number
2012-005615-92
Clinicaltrials.gov Identifier
Research summary
This is a two part study. Part 1 is a first in patient study to assess the safety and tolerability of multiple ascending doses of QBM076 for 14 consecutive days in Gold Class I-III chronic bronchitis COPD patients. Safety, tolerability pharmacokinetic and pharmacodynamic data will be used to determine the dose for Part 2.\nIn Part 2, evidence of efficacy of QBM076 for 56 consecutive days in Gold Class I-III chronic bronchitis COPD patients will be evaluated on the basis of a pharmacodynamic response in lung function by demonstrating significant improvement in three of five primary endpoints.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0674
Date of REC Opinion
24 Oct 2013
REC opinion
Favourable Opinion