Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.

This is a randomized, double-blind, placebo-controlled, three-period cross-over study in
asthma patients. The study will consist of a screening epoch, followed by a treatment epoch
which consists of three treatment periods, and will conclude with an end of study epoch.

Each subject will be assigned to 1 of 6 treatment sequences and will sequentially receive the
investigational products and placebo during the trial.

Key Inclusion Criteria:

- Male and female patients aged ≥ 18 and above

- Patients with a documented physician diagnosis of asthma for a period of at least 1
year prior to screening and who additionally meet the following criteria:

Patients receiving daily treatment with an inhaled corticosteroid up to the maximum dose
per day (as indicated in the package leaflet), on a stable regimen for at least 4 weeks
prior to screening.

- Pre-bronchodilator FEV1 ≥ 50 % and ≤ 90% of the predicted normal value for the patient
during screening.

- Patients who demonstrate an increase in FEV1 of ≥ 12% and ≥ 200 mL after
administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at
screening.

- Subjects must weigh at least 50 kg at screening to participate in the study, and must
have a body mass index (BMI) within the range of 18 to 40 kg/m2.

Key Exclusion Criteria:

-Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to
any of the following inhaled drugs, drugs of a similar class, or any component thereof:
Sympathomimetic amines / adrenoceptor agonist agents Lactose or any of the other excipients
of the study drug (including patients with history of galactose intolerance, Lapp lactase
deficiency or glucose-galactose malabsorption)

- Patients who have had an asthma attack/exacerbation requiring systemic steroids or
hospitalization or emergency room visit within 6 weeks of screening.

- Patients who have had a respiratory tract infection or asthma worsening within 4 weeks
prior to screening.

- Patients with a history of chronic lung diseases other than asthma

- Patients who have a decline in PEF from the reference PEF (taken at screening) of ≥30%
for 5 of 6 consecutive scheduled PEF readings (readings taken at morning and evening)
during at least 3 days of screening epoch prior to randomization.

- Patients who require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours
(over two consecutive days) during screening prior to randomization.

- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test.

- Patients with Type I diabetes or uncontrolled Type II diabetes (HbA1c > 9%) at
screening.

- Current smokers (urine cotinine > than the laboratory's lowest level of quantification
(LoQ of 500 ng/mL or lower)) and patients who have smoked or inhaled tobacco products
within the 6 month period prior to screening, or who have a smoking history of greater
than 10 pack years (Note: 1 pack is equivalent to 20 cigarettes. 10 pack years = 1
pack /day x 10 yrs., or ½ pack/day x 20 yrs.).