Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Public ClinicalTrials.gov record NCT02555683. 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 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: * patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population) * patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).
Study identification
- NCT ID
- NCT02555683
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 894 participants
Conditions and interventions
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
- Dec 10, 2015
- Primary completion
- Oct 20, 2019
- Completion
- Nov 3, 2019
- Last update posted
- May 17, 2020
2015 – 2019
United States locations
- U.S. sites
- 55
- U.S. states
- 21
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35209 | — |
| Novartis Investigative Site | Birmingham | Alabama | 35249 | — |
| Novartis Investigative Site | Gilbert | Arizona | 85234 | — |
| Novartis Investigative Site | Litchfield Park | Arizona | 85340 | — |
| Novartis Investigative Site | Peoria | Arizona | 85381 | — |
| Novartis Investigative Site | Little Rock | Arkansas | 72209 | — |
| Novartis Investigative Site | Hawaiian Gardens | California | 90716 | — |
| Novartis Investigative Site | Newport Beach | California | 92663 | — |
| Novartis Investigative Site | Redondo Beach | California | 90277 | — |
| Novartis Investigative Site | Riverside | California | 92506 | — |
| Novartis Investigative Site | Torrance | California | 90503 | — |
| Novartis Investigative Site | Westminster | California | 92683 | — |
| Novartis Investigative Site | New Haven | Connecticut | 06520 | — |
| Novartis Investigative Site | Brandon | Florida | 33511 | — |
| Novartis Investigative Site | New Smyrna Beach | Florida | 32168 | — |
| Novartis Investigative Site | Orlando | Florida | 32803 | — |
| Novartis Investigative Site | Orlando | Florida | 32806 | — |
| Novartis Investigative Site | Ormond Beach | Florida | 32174 | — |
| Novartis Investigative Site | Sebring | Florida | 33870 | — |
| Novartis Investigative Site | Winter Park | Florida | 32789 | — |
| Novartis Investigative Site | Gainesville | Georgia | 30501 | — |
| Novartis Investigative Site | Marietta | Georgia | 30060 | — |
| Novartis Investigative Site | Crowley | Louisiana | 70526 | — |
| Novartis Investigative Site | Zachary | Louisiana | 70791 | — |
| Novartis Investigative Site | Bangor | Maine | 04401 | — |
| Novartis Investigative Site | Gaithersburg | Maryland | 20878 | — |
| Novartis Investigative Site | White Marsh | Maryland | 21162 | — |
| Novartis Investigative Site | Livonia | Michigan | 48152 | — |
| Novartis Investigative Site | Ypsilanti | Michigan | 48197 | — |
| Novartis Investigative Site | Picayune | Mississippi | 39466 | — |
| Novartis Investigative Site | Bellevue | Nebraska | 68123 | — |
| Novartis Investigative Site | Lincoln | Nebraska | 68510 | — |
| Novartis Investigative Site | Omaha | Nebraska | 68131 | — |
| Novartis Investigative Site | Corning | New York | 14830 | — |
| Novartis Investigative Site | New York | New York | 10016 | — |
| Novartis Investigative Site | Charlotte | North Carolina | 28277 | — |
| Novartis Investigative Site | Gastonia | North Carolina | 28054 | — |
| Novartis Investigative Site | Monroe | North Carolina | 28112 | — |
| Novartis Investigative Site | New Bern | North Carolina | 28562 | — |
| Novartis Investigative Site | Whiteville | North Carolina | 28472 | — |
| Novartis Investigative Site | Wilmington | North Carolina | 28401 | — |
| Novartis Investigative Site | Winston-Salem | North Carolina | 27103 | — |
| Novartis Investigative Site | Canton | Ohio | 44718 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45231 | — |
| Novartis Investigative Site | Maumee | Ohio | 43537 | — |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73120 | — |
| Novartis Investigative Site | Jefferson Hills | Pennsylvania | 15025 | — |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15213 | — |
| Novartis Investigative Site | East Providence | Rhode Island | 02941 | — |
| Novartis Investigative Site | Boerne | Texas | 78006 | — |
| Novartis Investigative Site | McKinney | Texas | 75069 | — |
| Novartis Investigative Site | Plano | Texas | 75093 | — |
| Novartis Investigative Site | San Antonio | Texas | 78229 | — |
| Novartis Investigative Site | San Antonio | Texas | 78251 | — |
| Novartis Investigative Site | Fairfax | Virginia | 22030 | — |
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 178 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02555683, 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 May 17, 2020 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02555683 live on ClinicalTrials.gov.