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Dupilumab for Aspirin-exacerbated Respiratory Disease

Sponsor
Rochester General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03595488
Collaborator
(none)
11
Enrollment
1
Location
1
Arm
15.2
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dupilumab as add-on Therapy for Aspirin-exacerbated Respiratory Disease (AERD)
Actual Study Start Date :
Sep 5, 2018
Actual Primary Completion Date :
Dec 11, 2019
Actual Study Completion Date :
Dec 11, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. SNOT 22 Score [From baseline to completion of study(7 months total)]

      This is a patient-reported outcome score for chronic rhinosinusitis with or without nasal polyposis

    Secondary Outcome Measures

    1. UPSIT [From baseline to completion of study( 7 months total)]

      Univ. of Pennsylvania smell identification test

    2. Lund Mackay score [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.

    3. ACT score [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.

    4. Asthma Mini-AQLQ, 15 questions to assess quality of life. This assessment takes approximately 4-5 minutes to complete the questions. [From baseline to completion of study( 7 months total)]

      Validated asthma quality of life score

    5. Change in FEV1 [From baseline to completion of study( 7 months total)]

      Forced expiratory volume in first second from spirometry

    6. Change in FeNO [From baseline to completion of study( 7 months total)]

      Exhaled nitric oxide

    7. Eosinophil count [From baseline to completion of study( 7 months total)]

      Absolute eosinophil count

    8. Total serum IgE [From baseline to completion of study( 7 months total)]

      Total IgE

    9. Serum tryptase [From baseline to completion of study( 7 months total)]

      Biomarker

    10. Serum TARC (thymus and activation regulated cytokine) [From baseline to completion of study( 7 months total)]

      Biomarker

    11. Serum prostaglandin D2 [From baseline to completion of study( 7 months total)]

      Biomarker

    12. 24 hour urinary leukotriene E4 [From baseline to completion of study( 7 months total)]

      Biomarker

    13. To assess the safety and tolerability of dupilumab [From baseline to completion of study( 7 months total)]

      Adverse events

    14. To assess cumulative dose of systemic steroids [From baseline to completion of study( 7 months total)]

      Impact on systemic steroids

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rochester Regional Health - Allergy/Immunology Rochester New York United States 14607

    Sponsors and Collaborators

    • Rochester General Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    S. Shahzad Mustafa, Principle Investigator, Rochester General Hospital
    ClinicalTrials.gov Identifier:
    NCT03595488
    Other Study ID Numbers:
    • 1828-A-18
    First Posted:
    Jul 23, 2018
    Last Update Posted:
    Aug 26, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiration Disorders
    Respiratory Tract Diseases

    Study Results

    No Results Posted as of Aug 26, 2020