Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma

Novartis

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: QMF149 Twisthaler®; Drug: Mometasone Twisthaler®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00941798

EudraCT number 2009-011539-10

CQMF149A2210

Details and patient eligibility

About

Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.

Enrollment: 2,283 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a documented diagnosis of persistent asthma and who were currently treated with or qualified for treatment with both ICS and long-acting beta2-agonist (LABA) combination
• Patients demonstrating an increase in forced expiration volume in 1 second (FEV1) of ≥ 12% or ≥ 200 mLs within 30 minutes after administration of short-acting beta2-agonist (SABA)
• Patients with an FEV1 ≥ 50% of predicted normal

Exclusion criteria

• Patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD)
• Patients who had an asthma attack/exacerbation requiring hospitalization/emergency room visit or respiratory tract infection within 1 month prior to randomization
• Patients who had ever required ventilator support for respiratory failure
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Patients with concomitant pulmonary disease
• Patients with certain cardiovascular co-morbid conditions
• Patients with any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,283 participants in 2 patient groups

QMF149 Twisthaler® 500/400

Experimental group

Description:

QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)

Treatment:

Drug: QMF149 Twisthaler®

Mometasone Twisthaler®

Active Comparator group

Description:

Mometasone Twisthaler®, 400 µg QD

Treatment:

Drug: Mometasone Twisthaler®