Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
Public ClinicalTrials.gov record NCT03052517. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma. The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients: 1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and 2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039. By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.
Study identification
- NCT ID
- NCT03052517
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,538 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 21, 2017 (Actual)
- Primary completion
- Feb 19, 2020 (Actual)
- Completion
- Mar 16, 2020 (Actual)
- Last update posted
- Oct 12, 2020
2017 – 2020
United States locations
- U.S. sites
- 46
- U.S. states
- 23
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35209 | — |
| Novartis Investigative Site | Encinitas | California | 92024 | — |
| Novartis Investigative Site | Newport Beach | California | 92663 | — |
| Novartis Investigative Site | Orange | California | 92868 | — |
| Novartis Investigative Site | San Diego | California | 92117 | — |
| Novartis Investigative Site | Stockton | California | 95207 | — |
| Novartis Investigative Site | Walnut Creek | California | 94598 | — |
| Novartis Investigative Site | Westminster | California | 92683 | — |
| Novartis Investigative Site | Colorado Springs | Colorado | 80907 | — |
| Novartis Investigative Site | Denver | Colorado | 80230 | — |
| Novartis Investigative Site | Lafayette | Colorado | 80026 | — |
| Novartis Investigative Site | Miami | Florida | 33176 | — |
| Novartis Investigative Site | Tamarac | Florida | 33321 | — |
| Novartis Investigative Site | Winter Park | Florida | 32789 | — |
| Novartis Investigative Site | Marietta | Georgia | 30060 | — |
| Novartis Investigative Site | Overland Park | Kansas | 66210 | — |
| Novartis Investigative Site | Louisville | Kentucky | 40215 | — |
| Novartis Investigative Site | Zachary | Louisiana | 70791 | — |
| Novartis Investigative Site | Bangor | Maine | 04401 | — |
| Novartis Investigative Site | Columbia | Maryland | 21044 | — |
| Novartis Investigative Site | Waldorf | Maryland | 20602 | — |
| Novartis Investigative Site | Ypsilanti | Michigan | 48197 | — |
| Novartis Investigative Site | Missoula | Montana | 59804 | — |
| Novartis Investigative Site | Bellevue | Nebraska | 68123 | — |
| Novartis Investigative Site | La Vista | Nebraska | 68128 | — |
| Novartis Investigative Site | Omaha | Nebraska | 68131 | — |
| Novartis Investigative Site | Omaha | Nebraska | 68134 | — |
| Novartis Investigative Site | The Bronx | New York | 10459 | — |
| Novartis Investigative Site | Asheville | North Carolina | 28801 | — |
| Novartis Investigative Site | Gastonia | North Carolina | 28054 | — |
| Novartis Investigative Site | Columbus | Ohio | 43215 | — |
| Novartis Investigative Site | Edmond | Oklahoma | 73034 | — |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73120 | — |
| Novartis Investigative Site | Medford | Oregon | 97504 | — |
| Novartis Investigative Site | Altoona | Pennsylvania | 16602 | — |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15221 | — |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15241 | — |
| Novartis Investigative Site | East Providence | Rhode Island | 02941 | — |
| Novartis Investigative Site | Boerne | Texas | 78006 | — |
| Novartis Investigative Site | Fort Worth | Texas | 76244 | — |
| Novartis Investigative Site | McKinney | Texas | 75069 | — |
| Novartis Investigative Site | Plano | Texas | 75093 | — |
| Novartis Investigative Site | San Antonio | Texas | 78205 | — |
| Novartis Investigative Site | Richmond | Virginia | 23225 | — |
| Novartis Investigative Site | Bellingham | Washington | 98225 | — |
| Novartis Investigative Site | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 301 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03052517, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 12, 2020 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03052517 live on ClinicalTrials.gov.