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

Novartis

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: placebo to indacaterol maleate/mometasone furoate; Drug: indacaterol maleate / mometasone furoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605306

CQMF149A2203

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

indacaterol maleate/mometasone furoate

Experimental group

Description:

Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.

Treatment:

Drug: indacaterol maleate / mometasone furoate

Placebo

Placebo Comparator group

Description:

Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.

Treatment:

Drug: placebo to indacaterol maleate/mometasone furoate