Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Completed · Phase 3 · Has a placebo group
Conditions studied: Asthma
In brief
This study aimed to determine the efficacy and safety of QAW039 and QAW039 450 mg compared to 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 (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)
Key facts
- Study ID
- NCT02563067
- Run by
- Novartis Pharmaceuticals
- People needed
- 877
- Starts
- 2015-12-03
- Expected to finish
- 2019-08-02
- Last updated by the study team
- 2021-05-03
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Written informed consent.
- Male and female patients aged ≥12 years.
- A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
- Evidence of airway reversibility or airway hyper- reactivity.
- FEV1 ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to <18 years
- An ACQ score ≥1.5
- A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.
You may not qualify if…
- Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
- Subjects who have participated in another trial of QAW039.
- A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
- History of malignancy with the exception of local basal cell carcinoma of the skin.
- 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.
Where it is running
- Novartis Investigative Site — San Jose, California, United States
- Novartis Investigative Site — Stockton, California, United States
- Novartis Investigative Site — Colorado Springs, Colorado, United States
- Novartis Investigative Site — Denver, Colorado, United States
- Novartis Investigative Site — Winter Park, Florida, United States
- Novartis Investigative Site — Overland Park, Kansas, United States
- Novartis Investigative Site — Louisville, Kentucky, United States
- Novartis Investigative Site — New York, New York, United States
- Novartis Investigative Site — The Bronx, New York, United States
- Novartis Investigative Site — Edmond, Oklahoma, United States
- Novartis Investigative Site — Philadelphia, Pennsylvania, United States
- Novartis Investigative Site — Greenville, South Carolina, United States
- Novartis Investigative Site — Dallas, Texas, United States
- Novartis Investigative Site — Houston, Texas, United States
- Novartis Investigative Site — Plano, Texas, United States
- Novartis Investigative Site — Richmond, Virginia, United States
- Novartis Investigative Site — Richmond, Virginia, United States
- Novartis Investigative Site — Berazategui, Buenos Aires, Argentina
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — Lanus, Buenos Aires, Argentina
- Novartis Investigative Site — Mar del Plata, Buenos Aires, Argentina
- Novartis Investigative Site — Ranelagh, Partido de Berazate, Buenos Aires, Argentina
- Novartis Investigative Site — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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