Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00529529

Run by

Novartis Pharmaceuticals

People needed

805

Starts

2007-09-01

Expected to finish

2008-08-01

Last updated by the study team

2011-08-29

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigator Site — Phoenix, Arizona, United States
• Novartis Investigator Site — Encinitas, California, United States
• Novartis Investigator Site — Huntington Beach, California, United States
• Novartis Investigator Site — Long Beach, California, United States
• Novartis Investigator Site — Long Beach, California, United States
• Novartis Investigator Site — Los Angeles, California, United States
• Novartis Investigator Site x 2 sites — Oakland, California, United States
• Novartis Investigator Site — Orange, California, United States
• Novartis Investigator Site — Palmdale, California, United States
• Novartis Investigator Site — San Diego, California, United States
• Novartis Investigator Site — San Diego, California, United States
• Novartis Investigator Site — Walnut Creek, California, United States
• Novartis Investigator Site — Denver, Colorado, United States
• Novartis Investigator Site — Denver, Colorado, United States
• Novartis Investigator Site — Englewood, Colorado, United States
• Novartis Investigator Site — Lakewood, Colorado, United States
• Novartis Investigator Site — Brandon, Florida, United States
• Novartis Investigator Site — Largo, Florida, United States
• Novartis Investigator Site — Miami, Florida, United States
• Novartis Investigator Site — Panama City, Florida, United States
• Novartis Investigator Site — Pensacola, Florida, United States
• Novartis Investigator Site x 2 sites — Pensacola, Florida, United States
• Novartis Investigator Site — Tamarac, Florida, United States
• Novartis Investigator Site — Albany, Georgia, United States
• Novartis Investigator Site — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.