Phase 3
Completed N=805
Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma
Source: ClinicalTrials.gov NCT00529529 ↗Enrolled (actual)
805
Serious AEs
3.0%
Results posted
Aug 2011
Primary outcomePrimary: Percentage of Patients With at Least 1 Adverse Event During the 26 Weeks of the Study — 54.9; 66.4; 67.3 Percentage of patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With at Least 1 Adverse Event During the 26 Weeks of the Study |
54.9; 66.4; 67.3 | — |
| PRIMARY Systolic Blood Pressure 1 Hour Post-dose at Day 1 |
122.79; 122.60; 122.56 | — |
| PRIMARY Systolic Blood Pressure 1 Hour Post-dose at Week 12 |
120.29; 121.98; 122.02 | — |
| PRIMARY Diastolic Blood Pressure 1 Hour Post-dose at Day 1 |
76.67; 76.55; 77.08 | — |
| PRIMARY Diastolic Blood Pressure 1 Hour Post-dose at Week 12 |
75.38; 76.11; 76.96 | — |
| PRIMARY Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Day 1 |
404.46; 404.97; 405.05 | — |
| PRIMARY Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 12 |
404.93; 407.78; 406.98 | — |
| PRIMARY Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 21 |
406.41; 407.49; 407.23 | — |
| PRIMARY 24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 12 |
81.0; 81.7; 80.4 | — |
| PRIMARY 24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 26 |
79.4; 81.0; 79.2 | — |
| PRIMARY Serum Potassium 1 Hour Post-dose at Day 1 |
4.30; 4.24; 4.32 | — |
| PRIMARY Serum Potassium 1 Hour Post-dose at Week 12 |
4.31; 4.29; 4.33 | — |
| PRIMARY Blood Glucose 1 Hour Post-dose at Day 1 |
5.24; 5.45; 5.21 | — |
| PRIMARY Blood Glucose 1 Hour Post-dose at Week 12 |
5.27; 5.38; 5.23 | — |
| PRIMARY Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study |
92.9; 89.9; 90.0; 5.6; 9.3; 8.6 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at Week 12 + 1 Day, Day 85 |
2.61; 2.62; 2.54 | — |
| SECONDARY Number of Asthma Exacerbations Per Patient (Without Imputation) During the 26 Weeks of the Study |
0.17; 0.19; 0.19 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- 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
- 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.
- 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.
- Patients who suffer from chronic obstructive pulmonary disease (COPD) as diagnosed by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2006).
- 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.
- 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.
- 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.
- 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).
- 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.
Data sourced from ClinicalTrials.gov (NCT00529529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.