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

Indacaterol is a new form of an existing type of medicine, known as long acting
bronchodilators, control asthma and chronic obstructive pulmonary disease
(COPD) symptoms (similar to for example Serevent® or Foradil®).

Indacaterol has been approved in the European Union (EU) by the European
Medicines Agency (EMEA) for the treatment of patients with COPD, but not for
patients with asthma.

The purpose of this study is to give more information about indacaterol in
similar doses but given either once a day, twice a day, or once every other day
to patients with persistent asthma.

A multi-center, randomized, double-blind, placebo-controlled, parallel group,
repeated-dose study

The patients will be treated in one of the following 4 treatment groups:
1) Indacaterol 37.5 µg once daily in the morning and once daily in the evening
2) Indacaterol 75 µg 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 µg 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

Possible side effects for beta-agonists like indacaterol can include:
• tremor (shaking),
• headache,
• post-inhalation cough (cough after taking an inhalation of the drug),
• palpitations (increased awareness of the heart beating),
• muscle cramps,
• nausea (feeling like you are going to vomit),
• nervousness,
• possible changes in potassium (a salt in the body), and possible changes in
blood sugar (especially important in diabetics).