This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication. The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA. The study is also looking at: • What side effects may happen from taking dupilumab
This study is a Phase 3b in Canada Minors will not be enrolled in Denmark
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
Administered by subcutaneous (SC) injection
Administered by SC injection
Administered at a blinded dose
Kern Research, Inc
Bakersfield, California, United States
RECRUITINGModena Allergy & Asthma, Inc.
La Jolla, California, United States
RECRUITINGAntelope Valley Clinical Trials
Lancaster, California, United States
RECRUITINGArk Clinical Research - Long Beach
Long Beach, California, United States
Annualized severe asthma exacerbation rate
Time frame: Baseline through Week 52
Change in pre-bronchodilator Forced expiratory volume in the first second (FEV1)
Time frame: Baseline to week 12
Annualized cumulative dose of systemic corticosteroid exposure to treat severe asthma exacerbations
Time frame: Baseline to week 52
Change in Asthma Control Questionnaire (ACQ-5)
The ACQ-5 has 5 items that assess the most common asthma symptoms: 1. Frequency in past week awoken by asthma during the night, 2. Severity of asthma symptoms in the morning, 3. Limitation of daily activities due to asthma, 4. Shortness of breath due to asthma and 5. Wheeze. Participants are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The ACQ-5 global score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.
Time frame: Baseline to week 12
Proportion of participants achieving ACQ-5 <1.5
Time frame: At week 12
Change in pre-bronchodilator FEV1
Time frame: Baseline up to week 52
Change in percent predicted FEV1
Time frame: Baseline up to week 52
Change in peak expiratory flow (PEF)
Time frame: Baseline up to week 52
Change in forced vital capacity (FVC)
Time frame: Baseline up to week 52
Change in forced expiratory flow (FEF) 25-75%
Time frame: Baseline up to week 52
Change in FEV1: FVC ratio
Time frame: Baseline up to week 52
Change in post-bronchodilator FEV1
Time frame: Baseline up to week 52
Time to first severe exacerbation event
Time frame: Up to week 52
Proportion of participants achieving a 0.5-point improvement minimal clinically important difference (MCID) in ACQ-5
Time frame: Up to week 52
Incidence of Treatment-emergent adverse event (TEAEs)
Time frame: Up to week 52
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Newport Native Md, Inc.
Newport Beach, California, United States
RECRUITINGChildrens Hospital of Orange County Main Campus
Orange, California, United States
RECRUITINGRiviera Allergy Medical Center
Redondo Beach, California, United States
WITHDRAWNRaffi Tachdjian MD, Inc.
Santa Monica, California, United States
COMPLETEDBensch Clinical Research
Stockton, California, United States
RECRUITINGIntegrated Research of Inland, Inc.
Upland, California, United States
RECRUITING...and 74 more locations