RightFit
RecruitingPhase 4

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

A Randomized, Placebo-controlled, Parallel Group Study Designed to Assess the Change in Mucociliary Clearance After 12 Weeks of Treatment With Dupilumab in Patients With Moderate to Severe Asthma

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether dupilumab changes how well the lungs clear mucus in adults with moderate to severe asthma. People are assigned by chance to get dupilumab or a placebo, a treatment with no active medicine.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Older than 18.
  • Have moderate to severe Type 2 high asthma, a form linked to inflammation. The amount of air blown out in one second (FEV1) must be below 90% of the expected amount.
  • Use a medium to high dose of an inhaled steroid, with or without another asthma control medicine. The daily dose must equal at least 500 micrograms of fluticasone.
  • Have breathing improve by at least 12% after medicine at screening or in the past 2 years, or have a positive methacholine test during that time. This test checks how easily airways tighten.
  • Blow out less than 75% of the total air you can force out in the first second of a breathing test (FEV1/FVC).
  • Have more than 300 eosinophils, a type of white blood cell, per cubic millimeter of blood.
  • Have nitric oxide in your breath above 25 parts per billion, a sign of airway inflammation.
  • Have an Asthma Control Test score below 20.

Who can't join

  • Are pregnant, breastfeeding, or unwilling to take a pregnancy test.
  • Smoke now or have smoked more than 10 pack-years. One pack-year means smoking one pack a day for one year.
  • Have a body mass index (BMI) above 37. BMI is a measure based on height and weight.
  • Had a breathing infection or used antibiotics or oral prednisone, a steroid medicine, in the past 30 days.
  • Use or have ever used dupilumab, or currently or recently used anti-IL-5 medicines, which target a signal involved in inflammation.
  • Have another lung disease, including chronic obstructive pulmonary disease (COPD), which limits airflow.
  • Had cancer other than skin cancer, or drug or alcohol addiction, in the past 5 years.
  • Have another uncontrolled disease or any other condition that would make joining the study needlessly risky.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * FEV1/Forced Vital Capacity (FVC)\<75% * Blood Eosinophils (EOS) \>300 cells per mm3 * Exhaled Nitric Oxide (FeNO) \>25 parts per billion (ppb) * Asthma Control Test (ACT) score \<20 Exclusion Criteria: * 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 * Use of antibiotics or oral prednisone in the last 30 days * Current or previous use of dupilumab * Current or recent use of anti-IL-5 therapies * Any other criteria that place the subject at unnecessary risk * Diagnosis of other lung diseases including Chronic Obstructive Pulmonary Disease (COPD) * History of non-skin cell cancer in the last 5 years * Drug or alcohol addiction in the last 5 years * Any other uncontrolled disease

Study sites (1)

PA