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COMPLETEDPHASE2

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

A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma

NCT00941798•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - 70 years

Sex

ALL

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

Locations (146)

Novartis Investigator Site

Birmingham, Alabama, United States

Novartis Investigator Site

Buena Park, California, United States

Novartis Investigator Site

Encinitas, California, United States

Novartis Investigator Site

Fullerton, California, United States

Novartis Investigator Site

Long Beach, California, United States

Novartis Investigator Site

Los Angeles, California, United States

Novartis Investigator Site

Orange, California, United States

Novartis Investigator Site

Riverside, California, United States

Novartis Investigator Site

San Diego, California, United States

Novartis Investigator Site

San Jose, California, United States

Key Dates

Start Date

July 1, 2009

Primary Completion Date

May 1, 2011

Completion Date

May 1, 2011

Last Updated

August 31, 2012

Enrollment

2,283

ACTUAL participants

Conditions

Asthma

Interventions

QMF149 Twisthaler®

DRUG

Mometasone Twisthaler®

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma