Clinical trial NCT00941798: Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
LABA
Safety
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-07-20
Enrollment: 2283
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to First Serious Asthma Exacerbation
timeFrame: Up to 21 months
Secondary outcomes:
measure: Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.
timeFrame: up to 21 months
measure: Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids
timeFrame: Up to 21 months
measure: Number of Patients With at Least One Asthma Worsening Post-baseline
timeFrame: Up to 21 months
measure: Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit
timeFrame: Baseline to the end of treatment (varying durations, up to 21 months)
measure: Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit
timeFrame: 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
measure: Change From Baseline in Forced Vital Capacity (FVC) at Final Visit
timeFrame: 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
measure: Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period
timeFrame: Baseline to the end of treatment (varying durations, up to 21 months)
measure: Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime
timeFrame: Baseline to the end of treatment (varying durations, up to 21 months)
measure: Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime
timeFrame: Baseline to the end of treatment (varying durations, up to 21 months)
measure: Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime
timeFrame: Baseline to the end of treatment (varying durations, up to 21 months)
measure: Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit
timeFrame: Baseline to the end of treatment (varying durations, up to 21 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigator Site
state: Alabama
city: Buena Park
country: United States
facility: Novartis Investigator Site
state: California
city: Encinitas
country: United States
facility: Novartis Investigator Site
state: California
city: Fullerton
country: United States
facility: Novartis Investigator Site
state: California
city: Long Beach
country: United States
facility: Novartis Investigator Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigator Site
state: California
city: Orange
country: United States
facility: Novartis Investigator Site
state: California
city: Riverside
country: United States
facility: Novartis Investigator Site
state: California
city: San Diego
country: United States
facility: Novartis Investigator Site
state: California
city: San Jose
country: United States
facility: Novartis Investigator Site
state: California
city: San Mateo
country: United States
facility: Novartis Investigator Site
state: California
city: Vista
country: United States
facility: Novartis Investigator Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigator Site
state: California
city: Denver
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Engelwood
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Lakewood
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facility: Novartis Investigator Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Novartis Investigator Site
state: Colorado
city: Clearwater
country: United States
facility: Novartis Investigator Site
state: Florida
city: Clearwater
country: United States
facility: Novartis Investigator Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Port Charlotte
country: United States
facility: Novartis Investigator Site
state: Florida
city: Sarasota
country: United States
facility: Novartis Investigator Site
state: Florida
city: South Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigator Site
state: Florida
city: Albany
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Savannah
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Couer D'Alene
country: United States
facility: Novartis Investigator Site
state: Idaho
city: Chicago
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Normal
country: United States
facility: Novartis Investigator Site
state: Illinois
city: River Forest
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Skokie
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Springfield
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Evansville
country: United States
facility: Novartis Investigator Site
state: Indiana
city: Indianapolis
country: United States
facility: Novartis Investigator Site
state: Indiana
city: Iowa City
country: United States
facility: Novartis Investigator Site
state: Iowa
city: Topeka
country: United States
facility: Novartis Investigator Site
state: Kansas
city: Owensboro
country: United States
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state: Kentucky
city: Metarie
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facility: Novartis Investigator Site
state: Louisiana
city: Bangor
country: United States
facility: Novartis Investigative Site
state: Maine
city: Baltimore
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facility: Novartis Investigative Site
state: Maryland
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: North Dartmouth
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Plymouth
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Ozark
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Rolla
country: United States
facility: Novartis Investigator Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Warrensburg
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Bellevue
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Brick
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Cedar Knolls
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Skillman
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Novartis Investigator Site
state: New Mexico
city: Mineola
country: United States
facility: Novartis Investigative Site
state: New York
city: Newburgh
country: United States
facility: Novartis Investigative Site
state: New York
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: High Point
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Novartis Investigative site
state: North Carolina
city: Canton
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Marion
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Sylvania
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novartis Investigator Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novartis Investigator Site
state: Oklahoma
city: Portland
country: United States
facility: Novartis Investigator Site
state: Oregon
city: Blue Bell
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Lincoln
country: United States
facility: Novartis Investigator Site
state: Rhode Island
city: Mt. Pleasant
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Kingsport
country: United States
facility: Novartis Investigator Site
state: Tennessee
city: Dallas
country: United States
facility: Novartis Investigator Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigator Site
state: Texas
city: Dickinson
country: United States
facility: Novartis Investigator Site
state: Texas
city: El Paso
country: United States
facility: Novartis Investigator Site
state: Texas
city: Fort Worth
country: United States
facility: Novartis Investigator Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigator Site
state: Texas
city: New Braunfels
country: United States
facility: Novartis Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigator Site
state: Texas
city: South Burlington
country: United States
facility: Novartis Investigative Site
state: Vermont
city: Abingdon
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Kirkland
country: United States
facility: Novartis Investigator Site
state: Washington
city: Seattle
country: United States
facility: Novartis Investigator Site
state: Washington
city: Tacoma
country: United States
facility: Novartis Investigator Site
state: Washington
city: Milwaukee
country: United States
facility: Novartis Investigator Site
state: Wisconsin
city: Belo Horizonte
country: Brazil
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city: Florianopolis
country: Brazil
facility: Novartis Investigative Site
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
city: Salvador
country: Brazil
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Boskovice
country: Czech Republic
facility: Novartis Investigator Site
city: Breclav
country: Czech Republic
facility: Novartis Investigator Site
city: Brno - Bohunice
country: Czech Republic
facility: Novartis Investigator Site
city: Brno
country: Czech Republic
facility: Novartis Investigator Site
city: Hradec Kralove
country: Czech Republic
facility: Novartis Investigator Site
city: Jablonec nad Nisou
country: Czech Republic
facility: Novartis Investigator Site
city: Kladno
country: Czech Republic
facility: Novartis Investigator Site
city: Kutna Hora
country: Czech Republic
facility: Novartis Investigator Site
city: Liberec
country: Czech Republic
facility: Novartis Investigator Site
city: Most
country: Czech Republic
facility: Novartis Investigator Site
city: Plzen
country: Czech Republic
facility: Novartis Investigator Site
city: Praha
country: Czech Republic
facility: Novartis Investigator Site
city: Tabor
country: Czech Republic
facility: Novartis Investigator Site
city: Teplice
country: Czech Republic
facility: Novartis Investigator Site
city: Trutnov
country: Czech Republic
facility: Novartis Investigative Site
city: Balassagyarmat
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Deszk
country: Hungary
facility: Novartis Investigator Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
city: Mosonmagyarovar
country: Hungary
facility: Novartis Investigative Site
city: Nyiregyhaza
country: Hungary
facility: Novartis Investigative Site
city: Tatabanya
country: Hungary
facility: Novartis Investigative Site
city: Torokbalint
country: Hungary
facility: Novartis Investigative Site
city: Chennai
country: India
facility: Novartis Investigator Site
city: Coimbatore
country: India
facility: Novartis Investigator Site
city: Hyderabaad
country: India
facility: Novartis Investigator Site
city: Indore
country: India
facility: Novartis Investigator Site
city: Mangalore
country: India
facility: Novartis Investigator Site
city: Mumbai
country: India
facility: Novartis Investigator Site
city: Nagpur
country: India
facility: Novartis Investigator Site
city: Panjim
country: India
facility: Novartis Investigator Site
city: Gwangju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative SIte
city: Seoul
country: Korea, Republic of
facility: Novartis Investigator Site
city: Lima
country: Peru
facility: Novartis Investigator Site
city: Bardejov
country: Slovakia
facility: Novartis Investigator Site
city: Bojnice
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigator Site
city: Kosice
country: Slovakia
facility: Novartis Investigator Site
city: Levice
country: Slovakia
facility: Novartis Investigator Site
city: Liptovsky Hradok
country: Slovakia
facility: Novartis Investigator Site
city: Michalovce
country: Slovakia
facility: Novartis Investigator Site
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
city: Surany
country: Slovakia
facility: Novartis Investigative Site
city: Trencin
country: Slovakia
facility: Novartis Investigator Site
city: Vrable
country: Slovakia
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.