Evaluation of Dupilumab's Effects on Airway Inflammation in Patients with Asthma
- Conditions
- AsthmaMedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-001572-22-GB
- Lead Sponsor
- SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 42
• Male and female adults with a physician diagnosis of persistent asthma for =12 months.
• Existing treatment with medium to high dose inhaled corticosteroids in combination with a long acting beta agonist for at least 3 months with a stable dose =1 month prior to Visit 1 (Screening Visit).
• Treatment with a third asthma controller for at least 3 months with a stable dose =1 month prior to Visit 1 is allowed.
• Pre-bronchodilator forced expiratory volume (FEV1) 55 to 85% of predicted normal.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Patients <18 years or >65 years.
• Fractional exhaled nitric oxide (FeNO) <26 ppb at Visit 1 (Screening Visit).
• Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, eosinophilic granulomatosis with polyangiitis [Churg-Strauss Syndrome]) which may impair lung function.
• A patient who experiences an asthma exacerbation that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to Visit 1.
• A patient who has experienced an upper or lower respiratory tract infection within the 4 weeks prior to Visit 1.
• Evidence of lung disease(s) other than asthma.
• Previous smoker (smoking history >10 pack-years) or current smoker (within 6 months prior to Visit 1).
• Comorbid disease that might interfere with the evaluation of investigational medicinal product or conduct of study procedures (eg, bronchoscopy).
• Anti-immunoglobulin E (IgE) therapy (omalizumab) or any other biologic therapy within 6 months of Visit 1.
• Exposure to another investigative study medication within a time period prior to Visit 1 that is less than 5 half-lives of the study medication.
• Treatment with systemic (oral or injectable) corticosteroids within 28 days of Visit 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in patients with persistent asthma;Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo;Timepoint(s) of evaluation of this end point: Baseline, 12 weeks;<br> Primary end point(s): 1 - Change from baseline in number of inflammatory cells in the bronchial submucosa per square millimeter<br> 2 - Change from baseline in mucin-stained area in the bronchial submucosa per square millimeter<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1 -Absolute change from baseline in exhaled nitric oxide<br> 2 - Proportion of patients with antidrug antibodies<br> 3 - Proportion of patients with adverse events<br> ;<br> Timepoint(s) of evaluation of this end point: 1 - Baseline, 12 weeks <br> 2 & 3 - Up to 24 weeks<br>