Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Maleic acid; Mometasone Furoate

Criteria

Inclusion Criteria:

• Male and female adult patients aged 18-65 years (inclusive)

• Patients with mild-moderate asthma

• Forced expiratory volume in one second (FEV1) at Visits 1 and 2 are ≥60% of the predicted normal value for the patient.

• Body mass index (BMI) must be within the range of 18-32 kg/m^2.

• Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less.

Exclusion Criteria:

• Patients who suffer from chronic obstructive pulmonary disease (COPD)

• Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start

• QTcF interval > 450 msec in men and >470 msec in women

• Pregnant women or nursing mothers

• Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).

• History of immunocompromise, including a positive human immunodeficiency virus (HIV)

• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

• History of drug or alcohol abuse within 12 months of dosing

Other protocol-defined inclusion/exclusion criteria may apply.