To investigate Indacterol (QAB149) and Glycopyrrolate(NVA237)

• Research type

  Research Study

• Full title

  An open-label, randomized, four-period crossover study to compare the systemic exposure of multiple inhaled doses of indacaterol (QAB149) and NVA237 when administered alone, in free, or in fixed combination (QVA149) in healthy subjects

• IRAS ID

  36164

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Novartis

• Eudract number

  2009-015706-20

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  This will not be the first time the drugs will be given to man. The combination drug (QVA149) has been studied in 4 previous trials (2 studies in healthy volunteers and 2 studies in patients with COPD). QAB149 has been studied in healthy patients and adults with COPD and Asthma. It has also been studied in paediatric patients with Asthma. A total of about 6,003 patients/healthy volunteers have been exposed to QAB149 in 42 completed clinical trials across indications. NVA237 (Glycopyrolate) has been studied in several trials previously. It is currently licensed in an injection form. The purpose of this study is to see how much of each drug component can be detected in a blood sample, when daily doses are inhaled for 14 days alone or in combination in healthy volunteers. The study will take place at Guy's Drug Research Unit at Guy's Hospital. Twenty-four healthy subjects (male and female) will be enrolled with the aim of approximately 20 subjects completing the study. Each subject will participate in a screening period, four baseline periods, four treatment periods consisting of 14 days dosing, with a washout period of at least seven days between two consecutive treatment periods, and a study completion evaluation (5 - 7 days after the last dosing). Subjects will receive all four treatments. The information gained in this study will help the sponsor of this study to determine whether QAB149 and NVA237 are suitable for further studies in humans.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  09/H0804/80

• Date of REC Opinion

  3 Nov 2009

• REC opinion

  Favourable Opinion