Phase 3
N=877
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02563067 ↗Enrolled (actual)
877
Serious AEs
6.6%
Results posted
May 2021
Primary outcome: Primary: Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation — 0.73; 0.76; 1.06 Events/year — p=0.059
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- QAW039 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation |
0.73; 0.76; 1.06 | 0.059 |
| PRIMARY Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population |
0.76; 0.70; 0.93 | 0.369 |
| SECONDARY Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation |
0.73; 0.71; 0.58 | 0.369 |
| SECONDARY Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in High Eosinophils Subpopulation |
-0.92; -0.84; -0.75 | 0.369 |
| SECONDARY Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation |
0.192; 0.162; 0.124 | 0.369 |
| SECONDARY Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population |
0.62; 0.67; 0.55 | 0.824 |
| SECONDARY Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in Overall Population |
-0.83; -0.77; -0.70 | 0.824 |
| SECONDARY Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population |
0.153; 0.164; 0.103 | 0.369 |
Summary
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)
Eligibility Criteria
Inclusion Criteria
- 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 20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.
Data sourced from ClinicalTrials.gov (NCT02563067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.