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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001272-40 | 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 | 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 |
| 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 is calculated for the responses to 4 questions. | Baseline and Week 12 |
Not provided
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 | Andalusia | Alabama | 36420 | United States | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
| A Pediatric Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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Participants were recruited from centers in Brazil (8), Bulgaria (4), Canada (3), Colombia (4), Germany (5), Hungary (7), India (5), Israel (5), Italy (4), Peru (6), Republic of Korea (5), Russian Federation (14), Spain (8), United States (36), Vietnam (3).
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| ID | Title | Description |
|---|---|---|
| FG000 | QAW039 | QAW039 150mg once daily |
| FG001 | Placebo | Placebo once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 |
|
| 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) |
| 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 |
| Birmingham |
| Alabama |
| 35209 |
| United States |
| Novartis Investigative Site | Tucson | Arizona | 85745 | United States |
| Novartis Investigative Site | Los Angeles | California | 90048 | United States |
| Novartis Investigative Site | Newport Beach | California | 92663 | United States |
| Novartis Investigative Site | Rolling Hills Estates | California | 90274 | United States |
| Novartis Investigative Site | San Diego | California | 92117 | United States |
| Novartis Investigative Site | San Diego | California | 92120 | United States |
| Novartis Investigative Site | San Jose | California | 95117 | United States |
| Novartis Investigative Site | Stockton | California | 95207 | United States |
| Novartis Investigative Site | Colorado Springs | Colorado | 80907 | United States |
| Novartis Investigative Site | Denver | Colorado | 80230 | United States |
| Novartis Investigative Site | Lafayette | Colorado | 80026 | United States |
| Novartis Investigative Site | Miami | Florida | 33176 | United States |
| Novartis Investigative Site | Miami Gardens | Florida | 33169 | United States |
| Novartis Investigative Site | Tallahassee | Florida | 32308 | United States |
| Novartis Investigative Site | Winter Park | Florida | 32789 | United States |
| Novartis Investigative Site | Paducah | Kentucky | 42001 | United States |
| Novartis Investigative Site | Columbia | Maryland | 21044 | United States |
| Novartis Investigative Site | White Marsh | Maryland | 21162 | United States |
| Novartis Investigative Site | North Dartmouth | Massachusetts | 02747-3322 | United States |
| Novartis Investigative Site | Ann Arbor | Michigan | 48106 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55402 | United States |
| Novartis Investigative Site | Rochester | Minnesota | 55905 | United States |
| Novartis Investigative Site | Saint Charles | Missouri | 63301 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63110 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63141 | United States |
| Novartis Investigative Site | Warrensburg | Missouri | 64093 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68134 | United States |
| Novartis Investigative Site | Brooklyn | New York | 11235 | United States |
| Novartis Investigative Site | Raleigh | North Carolina | 27607 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45245 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43215 | United States |
| Novartis Investigative Site | Marion | Ohio | 43302 | United States |
| Novartis Investigative Site | Mayfield Heights | Ohio | 44124 | United States |
| Novartis Investigative Site | Tulsa | Oklahoma | 74136 | United States |
| Novartis Investigative Site | Altoona | Pennsylvania | 16602 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Novartis Investigative Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Novartis Investigative Site | Dallas | Texas | 75231 | United States |
| Novartis Investigative Site | New Braunfels | Texas | 78130 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78205 | United States |
| Novartis Investigative Site | Murray | Utah | 84107 | United States |
| Novartis Investigative Site | Newport News | Virginia | 23606 | United States |
| Novartis Investigative Site | Spokane | Washington | 99204 | United States |
| Novartis Investigative Site | Goiânia | Goiás | 74110-030 | Brazil |
| Novartis Investigative Site | Porto Alegre | Porto Alegre RS | 90610 000 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Novartis Investigative Site | Blumenau | Santa Catarina | 89030101 | Brazil |
| Novartis Investigative Site | São Bernardo do Campo | São Paulo | 09715 090 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 05437 010 | Brazil |
| Novartis Investigative Site | Sorocaba | São Paulo | Brazil |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Rousse | 7002 | Bulgaria |
| Novartis Investigative Site | Sofia | 1000 | Bulgaria |
| Novartis Investigative Site | Stara Zagora | 6000 | Bulgaria |
| Novartis Investigative Site | Kingston | Ontario | K7L 2V7 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M6H 3M2 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M9V 4B4 | Canada |
| Novartis Investigative Site | Windsor | Ontario | N8X 5A6 | Canada |
| Novartis Investigative Site | Ibague | Tolima Department | 730006 | Colombia |
| Novartis Investigative Site | Bogota DC | 110221 | Colombia |
| Novartis Investigative Site | Bogotá | 110111 | Colombia |
| Novartis Investigative Site | Bucaramanga | Colombia |
| Novartis Investigative Site | Berlin | 10367 | Germany |
| Novartis Investigative Site | Erlangen | 91052 | Germany |
| Novartis Investigative Site | Frankfurt | 60389 | Germany |
| Novartis Investigative Site | Halle | 06108 | Germany |
| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Hanover | 30167 | Germany |
| Novartis Investigative Site | Leipzig | 04357 | Germany |
| Novartis Investigative Site | Lübeck | 23552 | Germany |
| Novartis Investigative Site | Hajdúnánás | HUN | 4080 | Hungary |
| Novartis Investigative Site | Kapuvár | HUN | 9330 | Hungary |
| Novartis Investigative Site | Püspökladány | HUN | 4150 | Hungary |
| Novartis Investigative Site | Budapest | 1106 | Hungary |
| Novartis Investigative Site | Pécs | 7635 | Hungary |
| Novartis Investigative Site | Siófok | 8600 | Hungary |
| Novartis Investigative Site | Szigetszentmiklós | H-2310 | Hungary |
| Novartis Investigative Site | Ahmedabad | Gujarat | 380 060 | India |
| Novartis Investigative Site | Vadodara | Gujarat | 390022 | India |
| Novartis Investigative Site | Nashik | Maharashtra | 422007 | India |
| Novartis Investigative Site | Bikaner | Rajasthan | 334 001 | India |
| Novartis Investigative Site | Coimbatore | Tamil Nadu | 641 045 | India |
| Novartis Investigative Site | Dehradun | Uttarakhand | 248001 | India |
| Novartis Investigative Site | Ashkelon | 78278 | Israel |
| Novartis Investigative Site | Haifa | 3436212 | Israel |
| Novartis Investigative Site | Jerusalem | Israel |
| Novartis Investigative Site | Rehovot | 76100 | Israel |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Pisa | PI | 56124 | Italy |
| Novartis Investigative Site | Milan | 20157 | Italy |
| Novartis Investigative Site | Lima Cercado | Lima region | 01 | Peru |
| Novartis Investigative Site | San Isidro | Lima region | 27 | Peru |
| Novartis Investigative Site | San Martín de Porres | Lima region | 31 | Peru |
| Novartis Investigative Site | Cusco | 84 | Peru |
| Novartis Investigative Site | Lima | 1 | Peru |
| Novartis Investigative Site | Piura | 2000 | Peru |
| Novartis Investigative Site | San Juan | 00909 | Puerto Rico |
| Novartis Investigative Site | Barnaul | 656024 | Russia |
| Novartis Investigative Site | Chelyabinsk | 454021 | Russia |
| Novartis Investigative Site | Moscow | 109544 | Russia |
| Novartis Investigative Site | Moscow | 115478 | Russia |
| Novartis Investigative Site | N.Novgorod | 603126 | Russia |
| Novartis Investigative Site | Penza | 440067 | Russia |
| Novartis Investigative Site | Perm | 614068 | Russia |
| Novartis Investigative Site | Ryazan | 390039 | Russia |
| Novartis Investigative Site | Saint Petersburg | 191186 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194354 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Stavropol | 355000 | Russia |
| Novartis Investigative Site | Yaroslavl | 150054 | Russia |
| Novartis Investigative Site | Yekaterinburg | 620109 | Russia |
| Novartis Investigative Site | Wŏnju | Gangwon-do | 26427 | South Korea |
| Novartis Investigative Site | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
| Novartis Investigative Site | Hwaseong-si | Gyeonggi-do | 18450 | South Korea |
| Novartis Investigative Site | Suwon | Gyeonggi-do | 16499 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 03312 | South Korea |
| Novartis Investigative Site | Seoul | Seocho Gu | 06591 | South Korea |
| Novartis Investigative Site | Daegu | 705703 | South Korea |
| Novartis Investigative Site | Incheon | 21431 | South Korea |
| Novartis Investigative Site | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Marbella | Andalusia | 29603 | Spain |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Laredo | Cantabria | 39770 | Spain |
| Novartis Investigative Site | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Novartis Investigative Site | Barcelona | Vic | 08500 | Spain |
| Novartis Investigative Site | Barcelona | 08006 | Spain |
| Novartis Investigative Site | Barcelona | 08540 | Spain |
| Novartis Investigative Site | Girona | 17005 | Spain |
| Novartis Investigative Site | Santiago de Compostela | 1506 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Lund | SE-221 85 | Sweden |
| Novartis Investigative Site | Umeå | 907 40 | Sweden |
| Novartis Investigative Site | Visby | 621 50 | Sweden |
| Novartis Investigative Site | Bab Saadoun | 1007 | Tunisia |
| Novartis Investigative Site | Haiphong | 180000 | Vietnam |
| Novartis Investigative Site | Hanoi | 100000 | Vietnam |
| Novartis Investigative Site | Ho Chi Minh City | 700000 | Vietnam |
| FAS |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Two patients were randomized in error (mis-randomized) and did not receive any study drug; for these patients the reason for discontinuation is given as "technical problems"
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QAW039 | QAW039 150mg 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 | Two patients in the placebo group were randomized in error and did not receive any study drug; for these patients the reason for discontinuation is given as "technical problems" | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Two patients in the placebo group were randomized in error and did not receive any study drug; for these patients the reason for discontinuation is given as "technical problems" | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Two patients in the placebo group were randomized in error and did not receive any study drug; for these patients the reason for discontinuation is given as "technical problems" | 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 | 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 | Baseline and 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 is 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 | Baseline and Week 12 |
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| 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. | 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 | Puffs per day | Baseline (daily mean for up to three weeks prior to baseline visit) and Week 12 (daily mean post baseline up to Week 12) |
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| 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. | 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 | Baseline and Week 12 |
|
|
After signing informed consent to 30 days after last dose, assessed up to 16 weeks.
Not provided
Not provided
| 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 | 352 | 7 | 352 | 94 | 352 |
| EG001 | Placebo | Placebo | 0 | 350 | 3 | 350 | 116 | 350 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Prostate cancer | 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 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Respiratory tract infection viral | 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 |
| |
| Contusion | Injury, poisoning and procedural complications | 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 |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal 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 |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604875 | fevipiprant |
Not provided
Not provided
Not provided
| Male |
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| Asian |
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| Native American |
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| Pacific Islander |
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| Other |
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| Caucasian |
|
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