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Dupilumab for Aspirin-exacerbated Respiratory Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595488
Recruitment Status : Completed
First Posted : July 23, 2018
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
S. Shahzad Mustafa, Rochester General Hospital

Study Description
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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
Aspirin-exacerbated Respiratory Disease Drug: Dupilumab 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
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Study Type : Interventional  (Clinical Trial)
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 : September 5, 2018
Actual Primary Completion Date : December 11, 2019
Actual Study Completion Date : December 11, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dupilumab

Arms and Interventions
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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 Name: Matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. UPSIT [ Time Frame: From baseline to completion of study( 7 months total) ]
    Univ. of Pennsylvania smell identification test

  2. 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.

  3. 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.

  4. 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

  5. Change in FEV1 [ Time Frame: From baseline to completion of study( 7 months total) ]
    Forced expiratory volume in first second from spirometry

  6. Change in FeNO [ Time Frame: From baseline to completion of study( 7 months total) ]
    Exhaled nitric oxide

  7. Eosinophil count [ Time Frame: From baseline to completion of study( 7 months total) ]
    Absolute eosinophil count

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

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

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

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

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

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

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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595488


Locations
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United States, New York
Rochester Regional Health - Allergy/Immunology
Rochester, New York, United States, 14607
Sponsors and Collaborators
Rochester General Hospital
Investigators
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Principal Investigator: S Shahzad Mustafa, MD Lead Physician
More Information
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Publications:

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Responsible Party: S. Shahzad Mustafa, Principle Investigator, Rochester General Hospital
ClinicalTrials.gov Identifier: NCT03595488    
Other Study ID Numbers: 1828-A-18
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases