Dupilumab for Aspirin-exacerbated Respiratory Disease

August 25, 2020 updated by: S. Shahzad Mustafa, Rochester General Hospital

Dupilumab as add-on Therapy for Aspirin-exacerbated Respiratory Disease (AERD)

Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score > 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single blind, placebo controlled trial to be conducted in adult patients with AERD to determine the efficacy and safety of dupilumab in treating symptoms of chronic rhinosinusitis.

All subjects will be treated with the FDA-approved and the commercially available dose for adult atopic dermatitis of 300 mg every 2 weeks administered subcutaneously, based on the observed efficacy and safety of this dose. In addition to atopic dermatitis, this dose has also been shown to be efficacious in adult asthma.15 Patients will not be treated with a loading dose since other studies of dupilumab in asthma and chronic rhinosinusitis with nasal polyposis have not used a loading dose.

There will be a one month screening period to determine the patient's eligibility and establish symptom control and baseline parameters.

Patients will continue their background medications for chronic rhinosinusitis with nasal polyposis and asthma. These medications may include nasal corticosteroids, nasal antihistamines, systemic antihistamines, leukotriene receptor antagonists, 5 lipo-oxygenase inhibitors, inhaled corticosteroids, long-acting beta agonists, and long acting muscarinic antagonists. These controller medications will not be dispensed or supplied by the sponsor.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14607
        • Rochester Regional Health - Allergy/Immunology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients 18 years and older with a physician diagnosis of aspirin-exacerbated respiratory disease, as defined by a physician diagnosis of asthma, chronic rhinosinusitis with nasal polyposis, and a convincing clinical history of NSAID sensitivity
  2. All subjects must have a SNOT 22 score ≥ 19 despite standard medical therapy. This minimal SNOT 22 was calculated by taking the range of SNOT 22 scores in studies of normal controls plus 8.9, which is the minimal clinically meaningful improvement in SNOT 22 score detected by patients.
  3. Able to understand and willingness to sign informed consent
  4. Able to comply with study procedures

Exclusion Criteria:

  1. Patient < 18 years of age
  2. Pregnancy or breast feeding
  3. Current tobacco use
  4. Significant, uncontrolled medical conditions
  5. Ongoing malignancy or history of malignancy in remission within the past 12 months
  6. Current treatment with immunosuppressive medications except chronic oral steroids
  7. Currently increasing dose of aeroallergen immunotherapy (patients on stable dose of aeroallergen immunotherapy will be allowed to participate)
  8. Treatment with omalizumab, reslizumab, mepolizumab within 4 months of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm

Single-blinded, Dupilumab or matching placebo will be administered to the patients at the study visits. At each study visit, a single dose of dupilumab or placebo will be dispensed to the patients to be administered at home.

300 mg/2 ml solution in a single-dose pre-filled syringe with needle shield given once every 2 weeks in a subcutaneous injection
Drug: Dupilumab
dupilumab 300 mg subcutaneous injection every 2 weeks
Other Names:
  • Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SNOT 22 Score
Time Frame: From baseline to completion of study(7 months total)
This is a patient-reported outcome score for chronic rhinosinusitis with or without nasal polyposis
From baseline to completion of study(7 months total)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UPSIT
Time Frame: From baseline to completion of study( 7 months total)
Univ. of Pennsylvania smell identification test
From baseline to completion of study( 7 months total)
Lund Mackay score
Time Frame: From baseline to completion of study( 7 months total)
Objective score for CT sinus imaging, this is a widely used method for radiologic staging of chronic rhinosinusitis.
From baseline to completion of study( 7 months total)
ACT score
Time Frame: From baseline to completion of study( 7 months total)
Validated asthma control test, a series of 5 questions related to patient's asthma control over the previous 4 weeks.
From baseline to completion of study( 7 months total)
Asthma Mini-AQLQ, 15 questions to assess quality of life. This assessment takes approximately 4-5 minutes to complete the questions.
Time Frame: From baseline to completion of study( 7 months total)
Validated asthma quality of life score
From baseline to completion of study( 7 months total)
Change in FEV1
Time Frame: From baseline to completion of study( 7 months total)
Forced expiratory volume in first second from spirometry
From baseline to completion of study( 7 months total)
Change in FeNO
Time Frame: From baseline to completion of study( 7 months total)
Exhaled nitric oxide
From baseline to completion of study( 7 months total)
Eosinophil count
Time Frame: From baseline to completion of study( 7 months total)
Absolute eosinophil count
From baseline to completion of study( 7 months total)
Total serum IgE
Time Frame: From baseline to completion of study( 7 months total)
Total IgE
From baseline to completion of study( 7 months total)
Serum tryptase
Time Frame: From baseline to completion of study( 7 months total)
Biomarker
From baseline to completion of study( 7 months total)
Serum TARC (thymus and activation regulated cytokine)
Time Frame: From baseline to completion of study( 7 months total)
Biomarker
From baseline to completion of study( 7 months total)
Serum prostaglandin D2
Time Frame: From baseline to completion of study( 7 months total)
Biomarker
From baseline to completion of study( 7 months total)
24 hour urinary leukotriene E4
Time Frame: From baseline to completion of study( 7 months total)
Biomarker
From baseline to completion of study( 7 months total)
To assess the safety and tolerability of dupilumab
Time Frame: From baseline to completion of study( 7 months total)
Adverse events
From baseline to completion of study( 7 months total)
To assess cumulative dose of systemic steroids
Time Frame: From baseline to completion of study( 7 months total)
Impact on systemic steroids
From baseline to completion of study( 7 months total)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rochester General Hospital

Investigators

  • Principal Investigator: S Shahzad Mustafa, MD, Lead Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2018

Primary Completion (Actual)

December 11, 2019

Study Completion (Actual)

December 11, 2019

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1828-A-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aspirin-exacerbated Respiratory Disease

Clinical Trials on Dupilumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe