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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003995-38 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QAW039 450 mg qd Non-atopic | Experimental | QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1. |
|
| Placebo Non-atopic | Placebo Comparator | Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Non-atopic randomized in ratio of approximately 1:1. |
|
| QAW039 450 mg qd Atopic | Experimental | QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Atopic patients randomized in a ratio of approximate 1:1:1 |
|
| Fluticasone 150 mcg bid Atopic | Active Comparator | Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with 150 μg ICS and with background ICS (100 μg fluticasone, bid). As a consequence total ICS was 250 μg fluticasone bid. Atopic patients randomized in ratio of approximately 1:1:1 |
|
| Placebo Atopic | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAW039 | Drug | QAW039 supplied as hard gelatin capsule in unit dose strength of 150 mg. Patient took 450 mg once daily (3 capsules taken with food in the morning) for the approximate period of the study (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set | 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. Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF). Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug. | baseline,12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set | 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 FEV1 measurement taken prior to the first dose of randomized study drug. Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF). Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Kay | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Encinitas | California | 92024 | United States | ||
| Novartis Investigative Site |
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Total of 939 subjects were screened, 679 entered the inhaled corticosteroid (ICS) tapering run-in, 345 subjects were randomized; eleven randomized subjects discontinued the study prior to start of study drug. Patient disposition and baseline characteristics were presented for 334 subjects (received study drug)
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| ID | Title | Description |
|---|---|---|
| FG000 | QAW039 450 mg qd Non-atopic | QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo. |
| FG001 | Placebo Non-atopic |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Atopic patients andomized in ratio of approximately 1:1:1 |
|
| Placebo QAW039 | Drug | Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks) |
|
| Fluticasone 250 mcg | Drug | Fluticasone was supplied in inhalers with dose strength of 250 mcg. Patients took 250 mcg bid (morning and evening approximately 12 hours between doses) for a total dose of 500 mcg daily for the approximate period of the study (12 weeks). |
|
| Fluticasone 100 mcg | Drug | Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks). |
|
| baseline,12 weeks |
| Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set | 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 FEV1 measurement taken prior to the first dose of randomized study drug. Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF). Estimates are from a mixed effects model with treatment, subject population, treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug. | baseline,12 weeks |
| Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set | ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects. | baseline,12 weeks |
| Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set | ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects. | baseline,12 weeks |
| Huntington Beach |
| California |
| 92647 |
| United States |
| Novartis Investigative Site | Los Angeles | California | 90025 | United States |
| Novartis Investigative Site | Los Angeles | California | 90048 | United States |
| Novartis Investigative Site | Mission Viejo | California | 92691 | United States |
| Novartis Investigative Site | Orange | California | 92868 | United States |
| Novartis Investigative Site | Palmdale | California | 93551 | United States |
| Novartis Investigative Site | Riverside | California | 92506 | United States |
| Novartis Investigative Site | Rolling Hills Estates | California | 90274 | United States |
| Novartis Investigative Site | San Diego | California | 92123 | 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 | 80206 | United States |
| Novartis Investigative Site | Denver | Colorado | 80230 | United States |
| Novartis Investigative Site | Sarasota | Florida | 34233 | United States |
| Novartis Investigative Site | Owensboro | Kentucky | 42301 | United States |
| Novartis Investigative Site | North Dartmouth | Massachusetts | 02747 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55402 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63128 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63141 | United States |
| Novartis Investigative Site | Papillion | Nebraska | 68046 | United States |
| Novartis Investigative Site | Skillman | New Jersey | 08558 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28207 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45231 | United States |
| Novartis Investigative Site | Medford | Oregon | 97504-8741 | United States |
| Novartis Investigative Site | Portland | Oregon | 97213 | United States |
| Novartis Investigative Site | Lincoln | Rhode Island | 02865 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29407 | United States |
| Novartis Investigative Site | Seattle | Washington | 98104 | United States |
| Novartis Investigative Site | Erpent | 5100 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Barranquilla | Atlántico | Colombia |
| Novartis Investigative Site | Bogotá | Cundinamarca | Colombia |
| Novartis Investigative Site | Barranquilla | Colombia |
| Novartis Investigative Site | Medellín | Colombia |
| Novartis Investigative Site | Trutnov | Czech Republic | 541 01 | Czechia |
| Novartis Investigative Site | Hradec Králové | CZE | 500 05 | Czechia |
| Novartis Investigative Site | Karlovy Vary-Stara Rokle | CZE | 360 17 | Czechia |
| Novartis Investigative Site | Teplice | CZE | 415 01 | Czechia |
| Novartis Investigative Site | Marburg | Germany | D-35037 | Germany |
| Novartis Investigative Site | Wiesbaden | Germany | 65187 | Germany |
| Novartis Investigative Site | Berlin | 10717 | Germany |
| Novartis Investigative Site | Frankfurt | 60596 | Germany |
| Novartis Investigative Site | Leipzig | 04357 | Germany |
| Novartis Investigative Site | Lübeck | 23552 | Germany |
| Novartis Investigative Site | Witten | 58452 | Germany |
| Novartis Investigative Site | Hyderabad | Andhra Pradesh | 500 068 | India |
| Novartis Investigative Site | Panjim | Goa | 403 002 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 400 012 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 440010 | India |
| Novartis Investigative Site | Coimbatore | Tamil Nadu | 641 045 | India |
| Novartis Investigative Site | Bialystok | 15-010 | Poland |
| Novartis Investigative Site | Bialystok | 15-044 | Poland |
| Novartis Investigative Site | Lodz | 90-153 | Poland |
| Novartis Investigative Site | Wroclaw | 50-349 | Poland |
| Novartis Investigative Site | Bucharest | District 1 | 10457 | Romania |
| Novartis Investigative Site | Bucharest | District 3 | 030303 | Romania |
| Novartis Investigative Site | Bucharest | District 3 | 030317 | Romania |
| Novartis Investigative Site | Craiova | Dolj | 200515 | Romania |
| Novartis Investigative Site | Timișoara | Romania | 300736 | Romania |
| Novartis Investigative Site | Arad | 310013 | Romania |
| Novartis Investigative Site | Craiova | 200515 | Romania |
| Novartis Investigative Site | Deva | 330162 | Romania |
| Novartis Investigative Site | Durban | South Africa | 4001 | South Africa |
| Novartis Investigative Site | Cape Town | 7500 | South Africa |
| Novartis Investigative Site | Cape Town | 7531 | South Africa |
| Novartis Investigative Site | Cape Town | 7925 | South Africa |
| Novartis Investigative Site | Cape Town | 8001 | South Africa |
| Novartis Investigative Site | Gatesville | 7764 | South Africa |
| Novartis Investigative Site | Pretoria | 0181 | South Africa |
| Novartis Investigative Site | Gwangju | Gwangju | 501-757 | South Korea |
| Novartis Investigative Site | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
| Novartis Investigative Site | Suwon | Gyeonggi-do | 443-721 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 06591 | South Korea |
| Novartis Investigative Site | Cheongju-si | North Chungcheong | 28644 | South Korea |
Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
| FG002 | QAW039 450 mg qd Atopic | QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| FG003 | Fluticasone 150 µg Bid Atopic | Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| FG004 | Placebo Atopic | Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QAW039 450 mg qd Non-atopic | QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo. |
| BG001 | Placebo Non-atopic | Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo. |
| BG002 | QAW039 450 mg qd Atopic | QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| BG003 | Fluticasone 150 µg Bid Atopic | Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| BG004 | Placebo Atopic | Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| BG005 | 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 |
| ||||||||||||||||
| Duration of asthma | Mean | Standard Deviation | years |
| |||||||||||||||
| Subject population | Non-atopic defined as history of perennial symptoms with no clear inhaled allergic trigger AND a negative skin prick test (< 3mm diameter above background) or a negative specific IgE (<0.35 IU eq./ml). Atopic/allergic defined as skin prick test (≥ 3mm diameter above background) or a positive specific IgE (e.g.,RAST/CAP) test (≥0.35 IU eq/ml) | Number | Participants |
| |||||||||||||||
| Percentage of predicted FEV1 (%) pre-bronchodilator | Mean | Standard Deviation | Percentage |
| |||||||||||||||
| ACQ-6 score | Number of participants (n=92,94,51,42,54) | Mean | Standard Deviation | points |
|
| 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 Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set | 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. Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF). Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | liter | baseline,12 weeks |
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| Secondary | Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set | 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 FEV1 measurement taken prior to the first dose of randomized study drug. Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF). Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | liter | baseline,12 weeks |
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| Secondary | Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set | 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 FEV1 measurement taken prior to the first dose of randomized study drug. Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF). Estimates are from a mixed effects model with treatment, subject population, treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | liter | baseline,12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set | ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects. | Posted | Least Squares Mean | Standard Error | score | baseline,12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set | ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects. | Posted | Least Squares Mean | Standard Error | score | baseline,12 weeks |
|
Timeframe for AE
AE additional description
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 450 mg qd | QAW039 450 mg qd | 2 | 145 | 36 | 145 | ||
| EG001 | Fluticasone 150 mcg Bid | Fluticasone 150 mcg bid | 0 | 42 | 19 | 42 | ||
| EG002 | Placebo | Placebo | 3 | 147 | 35 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DENTAL CARIES | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ACUTE SINUSITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| CONJUNCTIVITIS VIRAL | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| SINUSITIS BACTERIAL | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| WOUND | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| SYNOVIAL CYST | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DYSMENORRHOEA | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (18.1) | 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 (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novaratis Pharmaceuticals | 862-778-8300 |
| 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 |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other |
|
| Atopic |
|
Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
|
|
|
QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| OG003 | Fluticasone 150 µg Bid Atopic | Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| OG004 | Placebo Atopic | Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
|
|
|
| OG002 | QAW039 450 mg qd Atopic | QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| OG003 | Fluticasone 150 µg Bid Atopic | Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| OG004 | Placebo Atopic | Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
|
|
|
| OG002 | QAW039 450 mg qd Atopic | QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| OG003 | Fluticasone 150 µg Bid Atopic | Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
| OG004 | Placebo Atopic | Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. |
|
|
|