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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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indacaterol maleate/mometasone furoate

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.

Group Type EXPERIMENTAL

indacaterol maleate / mometasone furoate

Intervention Type DRUG

Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo to indacaterol maleate/mometasone furoate

Intervention Type DRUG

Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.

Interventions

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indacaterol maleate / mometasone furoate

Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.

Intervention Type DRUG

placebo to indacaterol maleate/mometasone furoate

Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.

Intervention Type DRUG

Other Intervention Names

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QMF149

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No