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Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma
Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

NCT02573233

CompletedPhase 2

Sponsor: Sanofi

Conditions: Asthma

Interventions: Placebo, Dupilumab SAR231893/REGN668, fluticasone propionate and salmeterol, budesonide and formoterol, mometasone furoate and formoterol

Countries: United States, Canada, Denmark, Germany, Sweden, United Kingdom

Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

* 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 was allowed.
* Pre-bronchodilator forced expiratory volume (FEV1) 55 to 85% of predicted normal.

Exclusion criteria:

* Participants \<18 years or \>65 years.
* Fractional exhaled nitric oxide (FeNO) \<26 parts per billion (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 could impair lung function.
* A participant who experienced an asthma exacerbation that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to Visit 1.
* A participant who had 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 (e.g., 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.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Locations (16)
  • Tucson, Arizona, United States
  • Denver, Colorado, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • Winston-Salem, North Carolina, United States
  • Pittsburgh, Pennsylvania, United States
  • Montreal, Canada
  • Sainte-Foy, Canada
  • Hvidovre, Denmark
  • København NV, Denmark
  • Frankfurt am Main, Germany
  • Großhansdorf, Germany
  • Hanover, Germany
  • Lund, Sweden
  • London, United Kingdom
  • Oxford, United Kingdom