Clinical trial NCT03215758: Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Official title: A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: QAW039, uncontrolled asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-07-12
Enrollment: 675
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
* Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
* FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to \<18 years.
* Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days of the placebo run- in period.
* Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.
* Demonstrated reversible airway obstruction.
* Asthma control questionnaire (ACQ) score ≥ 1.5.

Exclusion Criteria:

* Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
* A resting QTcF (Fridericia) ≥450 msec (male) or

  ≥460 msec (female).
* Pregnant or nursing (lactating) women.
* Serious co-morbidities.
* Patients on \>20 mg of simvastatin, \> 40 mg of atorvastatin, \>40 mg of pravastatin, or \>2 mg of pitavastatin.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Pre-dose FEV1 at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Daytime Asthma Symptom Score
timeFrame: 12 weeks
measure: Change From Baseline in Daily Use of SABA
timeFrame: 12 weeks
measure: Change From Baseline in Asthma Quality of Life (AQLQ+12) Score
timeFrame: Week 12
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Huntington Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Long Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Mission Viejo
country: United States
facility: Novartis Investigative Site
state: California
city: Mountain View
country: United States
facility: Novartis Investigative Site
state: California
city: Orange
country: United States
facility: Novartis Investigative Site
state: California
city: Roseville
country: United States
facility: Novartis Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigative Site
state: California
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Tamarac
country: United States
facility: Novartis Investigative Site
state: Florida
city: Winter Park
country: United States
facility: Novartis Investigative Site
state: Florida
city: Albany
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Dacula
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Honolulu
country: United States
facility: Novartis Investigative Site
state: Hawaii
city: Lihue
country: United States
facility: Novartis Investigative Site
state: Hawaii
city: Overland Park
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Columbia
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Rolla
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Missoula
country: United States
facility: Novartis Investigative Site
state: Montana
city: Bellevue
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: La Vista
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Skillman
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Asheville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Gastonia
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: High Point
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Edmond
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Eugene
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Rapid City
country: United States
facility: Novartis Investigative Site
state: South Dakota
city: Boerne
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: El Paso
country: United States
facility: Novartis Investigative Site
state: Texas
city: Fort Worth
country: United States
facility: Novartis Investigative Site
state: Texas
city: McKinney
country: United States
facility: Novartis Investigative Site
state: Texas
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Greenfield
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Berazategui
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Lanus
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Santa Rosa
country: Argentina
facility: Novartis Investigative Site
state: La Pampa
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
state: Nueve De Julio
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
state: Rosario
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Salta
country: Argentina
facility: Novartis Investigative Site
city: Peine
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Cottbus
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Furstenwalde
country: Germany
facility: Novartis Investigative Site
city: Gauting
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Lubeck
country: Germany
facility: Novartis Investigative Site
city: Prien A Chiemsee
country: Germany
facility: Novartis Investigative Site
city: Rudersdorf
country: Germany
facility: Novartis Investigative Site
city: Schleswig
country: Germany
facility: Novartis Investigative Site
city: Schwerin
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
city: Budaors
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Ajka
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Godollo
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Culiacan
country: Mexico
facility: Novartis Investigative Site
state: Sinaloa
city: Rio De Janeiro
country: Mexico
facility: Novartis Investigative Site
city: Lipa City
country: Philippines
facility: Novartis Investigative Site
state: Batangas
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
state: Manila
city: Iloilo City
country: Philippines
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
state: SAU
city: Jeddah
country: Saudi Arabia
facility: Novartis Investigative Site
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kezmarok
country: Slovakia
facility: Novartis Investigative Site
city: Michalovce
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Spisska Nova Ves
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
city: Tygerberg
country: South Africa
facility: Novartis Investigative Site
state: Cape Town
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Chatsworth
country: South Africa
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
state: TUR
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Talas / Kayseri
country: Turkey
facility: Novartis Investigative Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigative Site
Study officials:
References: