Investigation of the effects of 3 different dosing regimes of QAB149.

• Research type

  Research Study

• Full title

  A multi-center, randomized, double-blind, placebo-controlled, parallel group, repeated-dose study to evaluate the efficacy, safety, tolerability and pharmacokinetics of three different dosing regimens of inhaled indacaterol maleate in patients with persistent asthma.

• IRAS ID

  45860

• Contact name

  Dave Singh

• Sponsor organisation

  Novartis Horsham Research Center

• Eudract number

  2010-018481-22

• Research summary

  Indacaterol is a long acting bronchodilator, which, by opening up the airways (breathing tubes) helps to make it easier to breathe and control chronic obstructive pulmonary disease (COPD) symptoms. Indacaterol is licensed for the treatment of COPD, but is also in development for treatment of asthma. The data available to date suggest that indacaterol is an effective, once daily bronchodilator with a full 24-hour duration of action with fast onset. Indacaterol has been generally well tolerated and demonstrated a good safety profile at all tested doses. However the impact on safety, tolerability and efficacy of different dosing regimes has not been previously evaluated. This study is designed to give more information about indacaterol which will be given either once a day, twice a day, or once every other day to subjects with persistent asthma. Subjects will be assigned to one of 4 treatment groups: 1) Indacaterol 37.5 æg once daily in the morning and once daily in the evening 2) Indacaterol 75 æg once daily in the morning and placebo (an inhaler which looks the same as the indacaterol inhaler but containing dummy medication) once daily in the evening 3) Indacaterol 150 æg once on odd days in the morning and placebo once on even days in the morning and daily in the evening 4) Placebo once daily in the morning and once daily in the evening Each of these treatments will be taken using an inhaler (??indacaterol inhaler?). Subjects will be asked to take the medication for 16 days and the entire study from screening to follow-up will last approx 54 days. Approximately 192 asthma subjects will take part in this study in up to approx. 40 centers in up to approx. 6 different countries (US, UK, Germany, Netherlands, France and Jordan).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/19

• Date of REC Opinion

  29 Apr 2010

• REC opinion

  Further Information Favourable Opinion