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

  dsingh@meu.org.uk

• Sponsor organisation

  Novartis Pharmaceuticals UK Limited

• Eudract number

  2012-005615-92

• Clinicaltrials.gov Identifier

  NCT01972776

• 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