An investigation of QMF149 in healthy volunteers

• Research type

  Research Study

• Full title

  A randomized, open label, four way complete crossover study to evaluate the potential for pharmacokinetic interaction following multiple inhaled doses of indacaterol acetate and mometasone furoate delivered in free or in a fixed combination (QMF149) via the concept 1 device in healthy subjects.

• IRAS ID

  106258

• Contact name

  SALVATORE FEBBRARO

• Sponsor organisation

  Novartis Pharmaceuticals UK Limited

• Eudract number

  2012-001146-18

• ISRCTN Number

  1

• Research summary

  The purpose of this study is to investigate a new drug called QMF149. QMF149 is being developed to treat two diseases which affect the lungs, asthma and chronic obstructive pulmonary disease (COPD). QMF149 is a treatment which must be inhaled. It works by widening the airways to the lungs and can therefore be helpful in the treatment of patients with asthma and COPD. QMF149 is not yet available on the market.QMF149 is made of the drugs, indacaterol acetate and mometasone furoate (MF). A form of indcaterol (Indacterol maleate) is available on prescription from the GP for the treatment of COPD, MF is available on prescription for the treatment of asthma. This study will look at the effects seen when QMF149 (indacaterol and MF combined into one capsule) is given to the subjects, compared to when indacaterol is given in a capsule on its own and when MF is given in a capsule on its own. Subject's will receive the following treatments over 4 different treatment periods, each treatment will be in the form of a capsule (containing the drug in powder form) which is placed into the Concept 1 device and inhaled: ?½Treatment A: 1 capsule containing indacaterol acetate ?½Treatment B: 1 capsule containing mometasone furoate (MF) ?½Treatment C: 2 capsules, 1 containing MF and 1 containing indacaterol acetate. MF inhaled first. ?½Treatment D: 1 capsule containing QMF149 (a combination of indacaterol acetate and MF) Safety parameters will be measured at pre-determined time-points during the study. Adverse events will also be continuously monitored. Blood samples will be taken to measure the levels of drug, potassium and glucose in the blood.

• REC name

  Wales REC 1

• REC reference

  12/WA/0167

• Date of REC Opinion

  20 Jun 2012

• REC opinion

  Further Information Favourable Opinion