Clinical trial NCT01836471: A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
Official title: A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-04-22
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.

Detailed description: This was a multi-centre, randomised, placebo-controlled, double blind, 3-arm study designed to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic and atopic asthmatics both inadequately controlled despite receiving a low dose ICS background therapy, over a 12 week treatment period. Efficacy and safety of a once daily dose of QAW039 was also compared with an increased dose of ICS in atopic asthmatics taking low dose ICS as background therapy.

Eligibility criteria: Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed
* Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
* Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
* An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
* Demonstration of reversible airway obstruction

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Acute illness other than asthma at the start of the study
* Patients with clinically significant laboratory abnormalities at screening
* Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
* Use of other investigational drugs at the time of enrollment

Primary outcomes:
measure: Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set
timeFrame: baseline,12 weeks
Secondary outcomes:
measure: Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set
timeFrame: baseline,12 weeks
measure: Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
timeFrame: baseline,12 weeks
measure: Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set
timeFrame: baseline,12 weeks
measure: Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
timeFrame: baseline,12 weeks
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Novartis Investigative Site
state: California
city: Huntington Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
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: Orange
country: United States
facility: Novartis Investigative Site
state: California
city: Palmdale
country: United States
facility: Novartis Investigative Site
state: California
city: Riverside
country: United States
facility: Novartis Investigative Site
state: California
city: Rolling Hills Estates
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: San Jose
country: United States
facility: Novartis Investigative Site
state: California
city: Stockton
country: United States
facility: Novartis Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Sarasota
country: United States
facility: Novartis Investigative Site
state: Florida
city: Owensboro
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: North Dartmouth
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Papillion
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Skillman
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Erpent
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
state: Atlantico
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
city: Medellín
country: Colombia
facility: Novartis Investigative Site
city: Hradec Kralove
country: Czech Republic
facility: Novartis Investigative Site
state: CZE
city: Karlovy Vary-Stara Rokle
country: Czech Republic
facility: Novartis Investigative Site
state: CZE
city: Teplice
country: Czech Republic
facility: Novartis Investigative Site
state: CZE
city: Trutnov
country: Czech Republic
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Andhra Pradesh
city: Panjim
country: India
facility: Novartis Investigative Site
state: Goa
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Coimbatore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Cheongju-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Chungcheongbuk-do
city: Bucheon-Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-Do
city: Suwon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Gwangju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 3
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 3
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: Dolj
city: Arad
country: Romania
facility: Novartis Investigative Site
city: Craiova
country: Romania
facility: Novartis Investigative Site
city: Deva
country: Romania
facility: Novartis Investigative Site
city: Timisoara
country: Romania
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
city: Gatesville
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Richard Kay
role: STUDY_DIRECTOR
References: