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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Sally E. Wenzel MD
Study ID
NCT04743791
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    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.
  • Placebo — OTHER
    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).

Study Details

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

Key Dates

Start date
Oct 17, 2022
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dupilumab
    Two injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose.
  • Placebo Comparator: Placebo
    Two injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day.

Primary Outcome Measure

Change in mucociliary clearance (MCC) rate [ Time Frame: Measured at 12 weeks after the start of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Pittsburgh Asthma Institute at UPMCPittsburghPennsylvania15213
Sally Wenzel, MD
[email protected]
412-647-9955
John Moore
[email protected]
412-648-6726

Find similar trials in Pittsburgh, PA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
The University of Pittsburgh Asthma Institute at UPMC· Pittsburgh, PA

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