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: NCT03215758
• Other study ID #: CQAW039A2316
• Secondary ID: 2017-001273-16
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2017
• Est. completion date: July 30, 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: 675
• Est. completion date: July 30, 2019
• Est. primary completion date: July 2, 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
Argentina	Novartis Investigative Site	Berazategui	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires	Nueve De Julio
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Lanus	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Salta
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	Santa Fe	Rosario
Argentina	Novartis Investigative Site	Santa Rosa	La Pampa
Germany	Novartis Investigative Site	Aschaffenburg
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Cottbus	Sachsen
Germany	Novartis Investigative Site	Furstenwalde
Germany	Novartis Investigative Site	Gauting
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lubeck
Germany	Novartis Investigative Site	Peine	Niedersachsen
Germany	Novartis Investigative Site	Prien A Chiemsee
Germany	Novartis Investigative Site	Rudersdorf
Germany	Novartis Investigative Site	Schleswig
Germany	Novartis Investigative Site	Schwerin
Germany	Novartis Investigative Site	Witten
Hungary	Novartis Investigative Site	Ajka
Hungary	Novartis Investigative Site	Budaors	HUN
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Godollo
Hungary	Novartis Investigative Site	Szeged
Mexico	Novartis Investigative Site	Culiacan	Sinaloa
Mexico	Novartis Investigative Site	Rio De Janeiro
Philippines	Novartis Investigative Site	Iloilo City
Philippines	Novartis Investigative Site	Lipa City	Batangas
Philippines	Novartis Investigative Site	Manila
Philippines	Novartis Investigative Site	Quezon City	Manila
Saudi Arabia	Novartis Investigative Site	Jeddah
Saudi Arabia	Novartis Investigative Site	Riyadh	SAU
Slovakia	Novartis Investigative Site	Bardejov	Slovak Republic
Slovakia	Novartis Investigative Site	Kezmarok
Slovakia	Novartis Investigative Site	Michalovce
Slovakia	Novartis Investigative Site	Poprad
Slovakia	Novartis Investigative Site	Presov
Slovakia	Novartis Investigative Site	Spisska Nova Ves
Slovakia	Novartis Investigative Site	Zilina
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Chatsworth
South Africa	Novartis Investigative Site	Durban
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Tygerberg	Cape Town
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Istanbul	TUR
Turkey	Novartis Investigative Site	Mersin
Turkey	Novartis Investigative Site	Talas / Kayseri
Turkey	Novartis Investigative Site	Yenisehir/Izmir
United States	Novartis Investigative Site	Albany	Georgia
United States	Novartis Investigative Site	Asheville	North Carolina
United States	Novartis Investigative Site	Bellevue	Nebraska
United States	Novartis Investigative Site	Boerne	Texas
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Columbia	Missouri
United States	Novartis Investigative Site	Dacula	Georgia
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Edmond	Oklahoma
United States	Novartis Investigative Site	El Paso	Texas
United States	Novartis Investigative Site	Eugene	Oregon
United States	Novartis Investigative Site	Flagstaff	Arizona
United States	Novartis Investigative Site	Fort Worth	Texas
United States	Novartis Investigative Site	Gastonia	North Carolina
United States	Novartis Investigative Site	Greenfield	Wisconsin
United States	Novartis Investigative Site	High Point	North Carolina
United States	Novartis Investigative Site	Honolulu	Hawaii
United States	Novartis Investigative Site	Huntington Beach	California
United States	Novartis Investigative Site	La Vista	Nebraska
United States	Novartis Investigative Site	Lihue	Hawaii
United States	Novartis Investigative Site	Long Beach	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	McKinney	Texas
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Mission Viejo	California
United States	Novartis Investigative Site	Missoula	Montana
United States	Novartis Investigative Site	Mountain View	California
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Overland Park	Kansas
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Rapid City	South Dakota
United States	Novartis Investigative Site	Rolla	Missouri
United States	Novartis Investigative Site	Roseville	California
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Skillman	New Jersey
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigative Site	Walnut Creek	California
United States	Novartis Investigative Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Germany,  Hungary,  Mexico,  Philippines,  Saudi Arabia,  Slovakia,  South Africa,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Pre-dose FEV1 at Week 12	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.	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 will be calculated for the responses to 4 questions.	12 weeks
Secondary	Change From Baseline in Daily Use of SABA	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.	12 weeks
Secondary	Change From Baseline in Asthma Quality of Life (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.	Week 12

External Links

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