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

NCT ID: NCT00941798

Last Updated: 2012-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma LABA Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QMF149 Twisthaler® 500/400

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

Group Type EXPERIMENTAL

QMF149 Twisthaler®

Intervention Type DRUG

Once daily via multi-dose dry-powder inhaler

Mometasone Twisthaler®

Mometasone Twisthaler®, 400 µg QD

Group Type ACTIVE_COMPARATOR

Mometasone Twisthaler®

Intervention Type DRUG

Once daily via multi-dose dry-powder inhaler

Interventions

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QMF149 Twisthaler®

Once daily via multi-dose dry-powder inhaler

Intervention Type DRUG

Mometasone Twisthaler®

Once daily via multi-dose dry-powder inhaler

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigator Site

Birmingham, Alabama, United States

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Buena Park, California, United States

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Encinitas, California, United States

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Fullerton, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Jose, California, United States

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San Mateo, California, United States

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Vista, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Engelwood, Colorado, United States

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Lakewood, Colorado, United States

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Wheat Ridge, Colorado, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Port Charlotte, Florida, United States

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Sarasota, Florida, United States

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South Miami, Florida, United States

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Tampa, Florida, United States

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Albany, Georgia, United States

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Columbus, Georgia, United States

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Savannah, Georgia, United States

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Couer D'Alene, Idaho, United States

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Chicago, Illinois, United States

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Normal, Illinois, United States

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River Forest, Illinois, United States

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Skokie, Illinois, United States

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Springfield, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Topeka, Kansas, United States

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Owensboro, Kentucky, United States

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Metarie, Louisiana, United States

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Bangor, Maine, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Plymouth, Minnesota, United States

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Ozark, Missouri, United States

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Rolla, Missouri, United States

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St Louis, Missouri, United States

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Warrensburg, Missouri, United States

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Bellevue, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Brick, New Jersey, United States

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Cedar Knolls, New Jersey, United States

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Skillman, New Jersey, United States

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Albuquerque, New Mexico, United States

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Mineola, New York, United States

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Newburgh, New York, United States

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Rochester, New York, United States

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High Point, North Carolina, United States

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Raleigh, North Carolina, United States

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Canton, Ohio, United States

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Columbus, Ohio, United States

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Marion, Ohio, United States

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Sylvania, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Blue Bell, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Mt. Pleasant, South Carolina, United States

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Kingsport, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dickinson, Texas, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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New Braunfels, Texas, United States

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San Antonio, Texas, United States

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South Burlington, Vermont, United States

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Abingdon, Virginia, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Belo Horizonte, , Brazil

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Florianópolis, , Brazil

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Porto Alegre, , Brazil

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Rio de Janeiro, , Brazil

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Salvador, , Brazil

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São Paulo, , Brazil

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Boskovice, , Czechia

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Brno, , Czechia

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Brno - Bohunice, , Czechia

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Břeclav, , Czechia

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Hradec Králové, , Czechia

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Jablonec nad Nisou, , Czechia

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Kladno, , Czechia

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Kutná Hora, , Czechia

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Liberec, , Czechia

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Most, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Tábor, , Czechia

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Teplice, , Czechia

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Trutnov, , Czechia

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Balassagyarmat, , Hungary

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Debrecen, , Hungary

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Deszk, , Hungary

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Győr, , Hungary

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Mosonmagyaróvár, , Hungary

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Nyíregyháza, , Hungary

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Tatabánya, , Hungary

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Törökbálint, , Hungary

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Chennai, , India

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Coimbatore, , India

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Hyderabaad, , India

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Indore, , India

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Mangalore, , India

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Mumbai, , India

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Nagpur, , India

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Panjim, , India

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Lima, , Peru

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Bardejov, , Slovakia

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Bojnice, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Levice, , Slovakia

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Liptovský Hrádok, , Slovakia

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Michalovce, , Slovakia

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Nitra, , Slovakia

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Šurany, , Slovakia

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Trenčín, , Slovakia

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Vráble, , Slovakia

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Gwangju, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Countries

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United States Brazil Colombia Czechia Hungary India Peru Slovakia South Korea

References

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Beasley RW, Donohue JF, Mehta R, Nelson HS, Clay M, Moton A, Kim HJ, Hederer BM. Effect of once-daily indacaterol maleate/mometasone furoate on exacerbation risk in adolescent and adult asthma: a double-blind randomised controlled trial. BMJ Open. 2015 Feb 3;5(2):e006131. doi: 10.1136/bmjopen-2014-006131.

Reference Type DERIVED
PMID: 25649209 (View on PubMed)

Other Identifiers

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EudraCT number 2009-011539-10

Identifier Type: -

Identifier Source: secondary_id

CQMF149A2210

Identifier Type: -

Identifier Source: org_study_id