Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226392
• Other study ID #: CQAW039A2317
• Secondary ID: 2017-001272-40
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: October 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: August 1, 2019
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• QAW039
QAW039 once daily
• Placebo
Placebo once daily

Locations

Country	Name	City	State
Brazil	Novartis Investigative Site	Blumenau	Santa Catarina
Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Porto Alegre	Porto Alegre RS
Brazil	Novartis Investigative Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Sao Bernardo do Campo	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Brazil	Novartis Investigative Site	Sorocaba	SP
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Ruse
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Stara Zagora
Canada	Novartis Investigative Site	Kingston	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Windsor	Ontario
Colombia	Novartis Investigative Site	Bogota
Colombia	Novartis Investigative Site	Bogota DC
Colombia	Novartis Investigative Site	Bucaramanga
Colombia	Novartis Investigative Site	Ibague	Tolima
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lubeck
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Hajdunanas	HUN
Hungary	Novartis Investigative Site	Kapuvár	HUN
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Puspokladany	HUN
Hungary	Novartis Investigative Site	Siofok
Hungary	Novartis Investigative Site	Szigetszentmiklos
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Bikaner	Rajasthan
India	Novartis Investigative Site	Coimbatore	Tamil Nadu
India	Novartis Investigative Site	DehraDun	Uttarakhand
India	Novartis Investigative Site	Nashik	Maharastra
India	Novartis Investigative Site	Vadodara	Gujarat
Israel	Novartis Investigative Site	Ashkelon
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Rehovot
Italy	Novartis Investigative Site	Brescia	BS
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Milano
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Rozzano	MI
Korea, Republic of	Novartis Investigative Site	Bucheon-Si	Gyeonggi-Do
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Hwaseong si	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Korea, Republic of	Novartis Investigative Site	Suwon si	Gyeonggi Do
Korea, Republic of	Novartis Investigative Site	Wonju	Gangwon-do
Peru	Novartis Investigative Site	Cercado De Lima	Lima
Peru	Novartis Investigative Site	Cusco
Peru	Novartis Investigative Site	Lima
Peru	Novartis Investigative Site	Piura
Peru	Novartis Investigative Site	San Isidro	Lima
Peru	Novartis Investigative Site	San Martin de Porres	Lima
Puerto Rico	Novartis Investigative Site	San Juan
Russian Federation	Novartis Investigative Site	Barnaul
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	N.Novgorod
Russian Federation	Novartis Investigative Site	Penza
Russian Federation	Novartis Investigative Site	Perm
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	Stavropol
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yekaterinburg
Spain	Novartis Investigative Site	Barcelona	Vic
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Girona
Spain	Novartis Investigative Site	Laredo	Cantabria
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Marbella	Andalucia
Spain	Novartis Investigative Site	Pozuelo de Alarcon	Madrid
Spain	Novartis Investigative Site	Santiago de Compostela
Spain	Novartis Investigative Site	Zaragoza
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Umea
Sweden	Novartis Investigative Site	Visby
Tunisia	Novartis Investigative Site	Bab saadoun
United States	Novartis Investigative Site	Altoona	Pennsylvania
United States	Novartis Investigative Site	Andalusia	Alabama
United States	Novartis Investigative Site	Ann Arbor	Michigan
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Brooklyn	New York
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Colorado Springs	Colorado
United States	Novartis Investigative Site	Columbia	Maryland
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Lafayette	Colorado
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Marion	Ohio
United States	Novartis Investigative Site	Mayfield Heights	Ohio
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Miami Gardens	Florida
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Mount Pleasant	South Carolina
United States	Novartis Investigative Site	Murray	Utah
United States	Novartis Investigative Site	New Braunfels	Texas
United States	Novartis Investigative Site	Newport Beach	California
United States	Novartis Investigative Site	Newport News	Virginia
United States	Novartis Investigative Site	North Dartmouth	Massachusetts
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Paducah	Kentucky
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Rochester	Minnesota
United States	Novartis Investigative Site	Rolling Hills Estates	California
United States	Novartis Investigative Site	Saint Charles	Missouri
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	San Jose	California
United States	Novartis Investigative Site	Spokane	Washington
United States	Novartis Investigative Site	Stockton	California
United States	Novartis Investigative Site	Tallahassee	Florida
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Tulsa	Oklahoma
United States	Novartis Investigative Site	Warrensburg	Missouri
United States	Novartis Investigative Site	White Marsh	Maryland
United States	Novartis Investigative Site	Winter Park	Florida
Vietnam	Novartis Investigative Site	Hai Phong
Vietnam	Novartis Investigative Site	Hanoi
Vietnam	Novartis Investigative Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Brazil,  Bulgaria,  Canada,  Colombia,  Germany,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Peru,  Puerto Rico,  Russian Federation,  Spain,  Sweden,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Pre-dose FEV1	Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.	Baseline and Week 12
Secondary	Change From Baseline in Daytime Asthma Symptom Score	Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score is calculated for the responses to 4 questions.	Baseline and Week 12
Secondary	Change From Baseline in Number of Puffs of SABA Taken Per Day	Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily - at the same time each morning and each evening, approximately 12 hours apart.	Baseline (daily mean for up to three weeks prior to baseline visit) and Week 12 (daily mean post baseline up to Week 12)
Secondary	Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score	AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.	Baseline and Week 12

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com