Oral BI 1026706 and placebo in patients with COPD.

• Research type

  Research Study

• Full title

  A Phase I randomized, double-blind, placebo-controlled, parallel-group trial of BI 1026706 administered orally as tablets twice daily for 4 weeks to patients with COPD in order to evaluate safety, tolerability, pharmacokinetics and effect on inflammation.

• IRAS ID

  190285

• Contact name

  Dave Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  Boehringer Ingelheim

• Eudract number

  2015-002123-25

• Duration of Study in the UK

  0 years, 6 months, 28 days

• Research summary

  This is a Phase I randomized, double-blind, placebo-controlled, parallel-group trial of BI 1026706 administered orally as tablets twice daily for 4 weeks to patients with COPD in order to evaluate safety, tolerability, pharmacokinetics and effect on inflammation. It is hoped to recruit 120 patients with COPD into this study. Patients will be treated with investigational drug BI 1026706 or Placebo worldwide in about 4 countries. Each patients participation in the trial will last approximately 66 days (maximum of 28 days screening period, 27 to 28 days of treatment period and 5 to 10 days follow-up period after last administration of trial medication). The trial will require approximately 8 visits to the trial clinic.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  16/NW/0011

• Date of REC Opinion

  24 Feb 2016

• REC opinion

  Further Information Favourable Opinion