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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001273-16 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QAW039 | Active Comparator | QAW039 once daily |
|
| Placebo | Placebo Comparator | Placebo once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAW039 | Drug | QAW039 once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change From Baseline in Daily Use of SABA |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Flagstaff | Arizona | 86001 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
| A Pediatric Plain Language Trial Summary is available on www.novctrd.com | View source |
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Participants were recruited from centers in Argentina (20), Germany (12), Hungary (4), Mexico (2), Philippines (4), Slovakia (7), South Africa (5), Turkey (5), United States (29)
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| ID | Title | Description |
|---|---|---|
| FG000 | QAW039 | QAW039 once daily |
| FG001 | Placebo | Placebo once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2017 | Jan 30, 2020 |
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| Drug |
Placebo once daily |
|
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 |
| 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 |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Novartis Investigative Site | Huntington Beach | California | 92647 | United States |
| Novartis Investigative Site | Long Beach | California | 90808 | United States |
| Novartis Investigative Site | Los Angeles | California | 90025 | United States |
| Novartis Investigative Site | Mission Viejo | California | 92691 | United States |
| Novartis Investigative Site | Mountain View | California | 94040 | United States |
| Novartis Investigative Site | Orange | California | 92868 | United States |
| Novartis Investigative Site | Roseville | California | 95661 | United States |
| Novartis Investigative Site | Walnut Creek | California | 94598 | United States |
| Novartis Investigative Site | Denver | Colorado | 80206 | United States |
| Novartis Investigative Site | Tamarac | Florida | 33321 | United States |
| Novartis Investigative Site | Winter Park | Florida | 32789 | United States |
| Novartis Investigative Site | Albany | Georgia | 31707 | United States |
| Novartis Investigative Site | Dacula | Georgia | 30019 | United States |
| Novartis Investigative Site | Honolulu | Hawaii | 96814 | United States |
| Novartis Investigative Site | Lihue | Hawaii | 96766 | United States |
| Novartis Investigative Site | Overland Park | Kansas | 66210 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40215 | United States |
| Novartis Investigative Site | Columbia | Missouri | 65203 | United States |
| Novartis Investigative Site | Rolla | Missouri | 65401 | United States |
| Novartis Investigative Site | Missoula | Montana | 59808 | United States |
| Novartis Investigative Site | Bellevue | Nebraska | 68123 | United States |
| Novartis Investigative Site | La Vista | Nebraska | 68128 | United States |
| Novartis Investigative Site | Skillman | New Jersey | 08558 | United States |
| Novartis Investigative Site | Asheville | North Carolina | 28801 | United States |
| Novartis Investigative Site | Gastonia | North Carolina | 28054 | United States |
| Novartis Investigative Site | High Point | North Carolina | 27262 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45231 | United States |
| Novartis Investigative Site | Edmond | Oklahoma | 73034 | United States |
| Novartis Investigative Site | Eugene | Oregon | 97401-4043 | United States |
| Novartis Investigative Site | Medford | Oregon | 97504 | United States |
| Novartis Investigative Site | Portland | Oregon | 97213 | United States |
| Novartis Investigative Site | Portland | Oregon | 97220 | United States |
| Novartis Investigative Site | Rapid City | South Dakota | 57701 | United States |
| Novartis Investigative Site | Boerne | Texas | 78006 | United States |
| Novartis Investigative Site | Dallas | Texas | 75231 | United States |
| Novartis Investigative Site | El Paso | Texas | 79903 | United States |
| Novartis Investigative Site | Fort Worth | Texas | 76109 | United States |
| Novartis Investigative Site | McKinney | Texas | 75069 | United States |
| Novartis Investigative Site | Seattle | Washington | 98122-4379 | United States |
| Novartis Investigative Site | Greenfield | Wisconsin | 53228 | United States |
| Novartis Investigative Site | Berazategui | Buenos Aires | 1888 | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1056ABJ | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1122AAK | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1425BEN | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1426ABP | Argentina |
| Novartis Investigative Site | Lanus | Buenos Aires | B8000XAV | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Novartis Investigative Site | Santa Rosa | La Pampa Province | 6300 | Argentina |
| Novartis Investigative Site | Buenos Aires | Nueve De Julio | B6500BWQ | Argentina |
| Novartis Investigative Site | Santa Fe | Rosario | S2000DBS | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000BRH | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000JKR | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | T4000IFL | Argentina |
| Novartis Investigative Site | Buenos Aires | C1012AAR | Argentina |
| Novartis Investigative Site | Buenos Aires | C1125ABE | Argentina |
| Novartis Investigative Site | Córdoba | X5003DCE | Argentina |
| Novartis Investigative Site | Mendoza | 5500 | Argentina |
| Novartis Investigative Site | Mendoza | M5500CBA | Argentina |
| Novartis Investigative Site | Salta | 4000 | Argentina |
| Novartis Investigative Site | Peine | Lower Saxony | 31224 | Germany |
| Novartis Investigative Site | Cottbus | Saxony | 03050 | Germany |
| Novartis Investigative Site | Aschaffenburg | 63739 | Germany |
| Novartis Investigative Site | Bamberg | 96049 | Germany |
| Novartis Investigative Site | Berlin | 12157 | Germany |
| Novartis Investigative Site | Berlin | 12203 | Germany |
| Novartis Investigative Site | Fürstenwalde | 15517 | Germany |
| Novartis Investigative Site | Gauting | 82131 | Germany |
| Novartis Investigative Site | Leipzig | 04275 | Germany |
| Novartis Investigative Site | Lübeck | 23552 | Germany |
| Novartis Investigative Site | Prien A Chiemsee | 83209 | Germany |
| Novartis Investigative Site | Rüdersdorf | 15562 | Germany |
| Novartis Investigative Site | Schleswig | 24837 | Germany |
| Novartis Investigative Site | Schwerin | 19055 | Germany |
| Novartis Investigative Site | Witten | 58452 | Germany |
| Novartis Investigative Site | Budaörs | HUN | 2040 | Hungary |
| Novartis Investigative Site | Ajka | 8400 | Hungary |
| Novartis Investigative Site | Budapest | 1125 | Hungary |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Gödöllő | 2100 | Hungary |
| Novartis Investigative Site | Szeged | 6722 | Hungary |
| Novartis Investigative Site | Culiacán | Sinaloa | 80230 | Mexico |
| Novartis Investigative Site | Río de Janeiro | 06700 | Mexico |
| Novartis Investigative Site | Lipa City | Batangas | 4217 | Philippines |
| Novartis Investigative Site | Quezon City | Manila | 1100 | Philippines |
| Novartis Investigative Site | Iloilo City | 5000 | Philippines |
| Novartis Investigative Site | Manila | 1000 | Philippines |
| Novartis Investigative Site | Riyadh | SAU | 11525 | Saudi Arabia |
| Novartis Investigative Site | Jeddah | 21423 | Saudi Arabia |
| Novartis Investigative Site | Bardejov | Slovak Republic | 085 01 | Slovakia |
| Novartis Investigative Site | Kežmarok | 060 01 | Slovakia |
| Novartis Investigative Site | Michalovce | 071 01 | Slovakia |
| Novartis Investigative Site | Poprad | 058 01 | Slovakia |
| Novartis Investigative Site | Prešov | 080 01 | Slovakia |
| Novartis Investigative Site | Spišská Nová Ves | 052 01 | Slovakia |
| Novartis Investigative Site | Žilina | 01207 | Slovakia |
| Novartis Investigative Site | Tygerberg | Cape Town | 7505 | South Africa |
| Novartis Investigative Site | Cape Town | 7500 | South Africa |
| Novartis Investigative Site | Chatsworth | 4092 | South Africa |
| Novartis Investigative Site | Durban | 4001 | South Africa |
| Novartis Investigative Site | Pretoria | 0183 | South Africa |
| Novartis Investigative Site | Istanbul | TUR | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Adana | 01330 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34020 | Turkey (Türkiye) |
| Novartis Investigative Site | Mersin | 33343 | Turkey (Türkiye) |
| Novartis Investigative Site | Talas / Kayseri | 38039 | Turkey (Türkiye) |
| Novartis Investigative Site | Yenisehir/Izmir | 35110 | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QAW039 | QAW039 once daily |
| BG001 | Placebo | Placebo once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization. | Posted | Least Squares Mean | Standard Error | Liters | Week 12 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization. | Posted | Least Squares Mean | Standard Error | Score | 12 weeks |
|
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| 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. | Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization. | Posted | Least Squares Mean | Standard Error | Number of puffs | 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. | Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 12 |
|
|
After signing informed consent to 30 days after last dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QAW039 150 mg | QAW039 150 mg | 0 | 339 | 1 | 339 | 94 | 339 |
| EG001 | Placebo | Placebo | 1 | 336 | 5 | 336 | 102 | 336 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceutical | 862-778-8300 | Novartis.email@novartis.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2019 | Jan 30, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000604875 | fevipiprant |
Not provided
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Not provided
| Male |
|
| Black |
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| Asian |
|
| Native American |
|
| Pacific Islander |
|
| Unknown |
|
| Other |
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