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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04743791
• Other study ID #: STUDY20020131
• Status: Recruiting
• Phase: Phase 4
• Start date: October 17, 2022
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: John Moore
• Phone: 412-648-6726
• Email: mooreja6[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Dupilumab
Dupilumab is supplied as a sterile aqueous solution for SC injection at the concentration of 175 mg/mL in glass pre-filled syringe to deliver 200 mg in 1.14mL.

Other:
• Placebo
Sterile placebo for dupilumab will be provided in identically matched glass pre-filled syringe to deliver 200 mg in 1.14mL, which will match dupilumab 200 mg (1.14mL).

Locations

Country	Name	City	State
United States	The University of Pittsburgh Asthma Institute at UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sally E. Wenzel MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mucociliary clearance (MCC) rate	MCC is measured using an aerosol-based nuclear imaging technique	Measured at 12 weeks after the start of treatment
Secondary	Change in FEV1% predicted	Assessed using spirometry after bronchodilator administration.	Measured from baseline to 12 weeks after start of treatment
Secondary	Change in ACT score	Measured via the Asthma Control Test questionnaire. Scores range from 5 (poor control of asthma) to 25 (complete control of asthma).	Measured from baseline to 12 weeks after start of treatment
Secondary	Change in sputum eosinophils and T2 gene mean	Measured via sputum induction to obtain airway cells and fluid from patients.	Measured from baseline to 12 weeks after start of treatment
Secondary	Change in mucus plugging score by CT	Radiologists will visually assess the presence or absence of mucus plugging in segmental airways and will provide a mucus plugging score	Measured from baseline to 12 weeks after start of treatment
Secondary	Whole lung MCC90, AAC90	Measured via mucociliary clearance imaging	Measured from baseline to 12 weeks after start of treatment
Secondary	Peripheral and central lung MCC90, MCC240, AAC90	Measured via mucociliary clearance imaging	Measured from baseline to 12 weeks after start of treatment