Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma

ConditionAsthma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSally E. Wenzel MD

About this trial

Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.

Eligibility criteria

Qualifiers

Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) <90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller

Age > 18

Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)

Reversibility >/= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening

Disqualifiers

Pregnant, nursing, or unwilling to test for pregnancy

Current smoker or >10 pack year smoking history

Body Mass Index (BMI)>37

Respiratory infection in the last 30 days

Trial design

Treatments tested in this trial

  • Dupilumab
  • Placebo

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sally E. Wenzel MD

Lead sponsor

University of Pittsburgh

Sponsor institution