Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Indacaterol 300 μg; Salmeterol 50 μg; Placebo to indacaterol; Placebo to salmeterol
Intervention description: Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).; Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.; Placebo to indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI).; Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 805.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: asthma; QAB149; indacaterol

Summary:

      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.
    

Eligibility criteria:

        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.