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
2 other identifiers
interventional
2,283
9 countries
146
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Jul 2009
Typical duration for phase_2 asthma
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
June 5, 2012
CompletedAugust 31, 2012
August 1, 2012
1.8 years
July 14, 2009
May 3, 2012
August 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to First Serious Asthma Exacerbation
Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.
Up to 21 months
Secondary Outcomes (11)
Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.
up to 21 months
Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids
Up to 21 months
Number of Patients With at Least One Asthma Worsening Post-baseline
Up to 21 months
Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit
Baseline to the end of treatment (varying durations, up to 21 months)
Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit
Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose
- +6 more secondary outcomes
Study Arms (2)
QMF149 Twisthaler® 500/400
EXPERIMENTALQMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
Mometasone Twisthaler®
ACTIVE COMPARATORMometasone Twisthaler®, 400 µg QD
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (146)
Novartis Investigator Site
Birmingham, Alabama, 35209, United States
Novartis Investigator Site
Buena Park, California, 90620, United States
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Encinitas, California, 92024, United States
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Fullerton, California, 92835, United States
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Long Beach, California, 90808, United States
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Los Angeles, California, 90025, United States
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Orange, California, 92868, United States
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Riverside, California, 92506, United States
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San Diego, California, 92123, United States
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San Jose, California, 95117, United States
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San Mateo, California, 94401, United States
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Vista, California, 92083, United States
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Walnut Creek, California, 94598, United States
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Denver, Colorado, 80230, United States
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Engelwood, Colorado, 80112, United States
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Lakewood, Colorado, 80401, United States
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Wheat Ridge, Colorado, 80033, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33765, United States
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Miami, Florida, 33136, United States
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Miami, Florida, 33157, United States
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Port Charlotte, Florida, 33952, United States
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Sarasota, Florida, 34233, United States
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South Miami, Florida, 33143, United States
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Tampa, Florida, 33603, United States
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Albany, Georgia, 31707, United States
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Columbus, Georgia, 31904, United States
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Savannah, Georgia, 31406, United States
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Couer D'Alene, Idaho, 83814, United States
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Chicago, Illinois, 60612, United States
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Normal, Illinois, 61761, United States
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River Forest, Illinois, 60305, United States
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Skokie, Illinois, 60076, United States
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Springfield, Illinois, 62703, United States
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Evansville, Indiana, 47713, United States
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Indianapolis, Indiana, 46208, United States
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Iowa City, Iowa, 52240, United States
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Topeka, Kansas, 66606, United States
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Owensboro, Kentucky, 42301, United States
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Metarie, Louisiana, 70002, United States
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Bangor, Maine, 04401, United States
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Baltimore, Maryland, 21236, United States
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Baltimore, Maryland, 21237, United States
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North Dartmouth, Massachusetts, 02747, United States
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Minneapolis, Minnesota, 55402, United States
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Plymouth, Minnesota, 55441, United States
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Ozark, Missouri, 65721, United States
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Rolla, Missouri, 65401, United States
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St Louis, Missouri, 63141, United States
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Warrensburg, Missouri, 64093, United States
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Bellevue, Nebraska, 68123, United States
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Omaha, Nebraska, 68130, United States
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Omaha, Nebraska, 68131, United States
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Brick, New Jersey, 08724, United States
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Cedar Knolls, New Jersey, 07927, United States
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Skillman, New Jersey, 08558, United States
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Albuquerque, New Mexico, 87108, United States
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Mineola, New York, 11501, United States
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Newburgh, New York, 12550, United States
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Rochester, New York, 14618-2638, United States
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High Point, North Carolina, 27262, United States
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Raleigh, North Carolina, 27607, United States
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Canton, Ohio, 44718, United States
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Columbus, Ohio, 43213, United States
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Marion, Ohio, 43302, United States
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Sylvania, Ohio, 43560, United States
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Oklahoma City, Oklahoma, 73104, United States
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Oklahoma City, Oklahoma, 73112, United States
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Oklahoma City, Oklahoma, 73120, United States
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Portland, Oregon, 97213, United States
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Blue Bell, Pennsylvania, 19422, United States
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Philadelphia, Pennsylvania, 19115, United States
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Philadelphia, Pennsylvania, 19140, United States
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Pittsburgh, Pennsylvania, 15221, United States
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Lincoln, Rhode Island, 02865, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Kingsport, Tennessee, 37660, United States
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Dallas, Texas, 75230, United States
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Dallas, Texas, 75231, United States
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Dickinson, Texas, 77539, United States
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El Paso, Texas, 79925, United States
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Fort Worth, Texas, 76132, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77054, United States
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New Braunfels, Texas, 78130, United States
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San Antonio, Texas, 78229, United States
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South Burlington, Vermont, 05403, United States
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Abingdon, Virginia, 24210, United States
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Kirkland, Washington, 98034, United States
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Seattle, Washington, 98105, United States
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Tacoma, Washington, 98405, United States
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Milwaukee, Wisconsin, 53209, 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
Related Publications (1)
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.
PMID: 25649209DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2009
First Posted
July 20, 2009
Study Start
July 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
August 31, 2012
Results First Posted
June 5, 2012
Record last verified: 2012-08