Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma
Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma
This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg
 capsules) once daily [od]), compared with salmeterol (50 μg twice a day [b.i.d.]), over 26
 weeks, in patients with moderate to severe persistent asthma.
Inclusion Criteria:

 1. Male and female patients aged ≥ 12 years (or ≥ 18 years depending upon regulatory
 and/or Institutional Review Board/Independent Ethics Committee/Research Ethics Board
 [IRB/IEC/REB] approval) who have signed an informed consent form.

 2. Patients with moderate to severe persistent asthma, diagnosed according to the Global
 Initiative for Asthma (GINA) guidelines (Updated 2006) and who additionally meet the
 following criteria:

 -  Patients who have used treatment with a bronchodilator, either regularly or
 on-demand, and who had used a daily dose of at least 100 μg beclomethasone
 dipropionate (or equivalent) for at least 1 month prior to screening.

 -  Patients whose forced expiratory volume in 1 second (FEV1) is ≥ 50% of the
 predicted normal value.

 -  Patients with documented (in the previous 6 months) or who demonstrate (prior to
 randomization) a ≥ 12% and at least 200 ml increase in FEV1, after inhaling 200
 μg salbutamol.

 Exclusion Criteria:

 1. Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they
 meet pre-specified definitions of post-menopausal or are using pre-specified
 acceptable methods of contraception.

 2. Patients who have used tobacco products within the 12 month period prior to screening,
 or who have a smoking history of greater than 10 pack years.

 3. Patients who suffer from chronic obstructive pulmonary disease (COPD) as diagnosed by
 the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2006).

 4. Patients who have had emergency room treatment for an acute asthma attack in the 6
 weeks prior to screening or who have been hospitalized for an acute asthma attack in
 the 6 months prior to screening, or at any time between screening and Week 1.

 5. Patients with diabetes Type I or those with uncontrolled diabetes Type II including
 patients with a history of blood glucose levels consistently outside the normal range
 or glycosylated hemoglobin (HbA1C) > 8.0% measured at screening.

 6. Patients who, in the judgment of the investigator or the responsible Novartis
 personnel, have a clinically significant condition or a clinically relevant laboratory
 abnormality that might compromise patient safety or compliance, interfere with
 evaluation, or preclude completion of the study.

 7. Patients with a history of long QT syndrome, or whose QTc interval (Bazett's formula)
 is prolonged to > 450 ms (males) or > 470 ms (females).

 8. Certain medications for asthma and allied conditions such as long-acting
 bronchodilators must not be used prior to screening and for a pre-specified minimum
 washout period.

 Other protocol-defined inclusion/exclusion criteria applied to the study.