Subcutaneous Immunotherapy for Mouse in Adults

Completed · Phase 1/Phase 2

Conditions studied: Asthma, Perennial Allergic Rhinitis

In brief

This is an open label trial of mouse allergenic extract administered by subcutaneous injection in adults with asthma and mouse sensitivity. The study is designed to evaluate: * the safety of this therapy when given by injection * biomarkers of the immune response and * whether the therapy would be effective in treating allergic asthma.

Key facts

Study ID

NCT02532179

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

12

Starts

2015-10-01

Expected to finish

2016-10-01

Last updated by the study team

2018-03-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who meet any of the following criteria are not eligible for enrollment but may be reassessed. Participants are ineligible if they:
• Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception);
• Cannot perform spirometry at Screening;
• Have an asthma severity classification at Recruitment of severe persistent, using the NAEPP classification, as evidenced by at least one of the following:
• Requires a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid;
• Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months;
• Have been treated with depot steroids within the last 12 months;
• Have been hospitalized for asthma within the 6 months prior to recruitment;
• Have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment.
• Do not have access to a phone (needed for scheduling appointments);
• Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study;
• Have previously been treated with anti-IgE therapy within 1 year of recruitment;
• Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study;
• Refuses to sign the Epinephrine Auto-injector Training Form.

You may not qualify if…

• Participants who meet any of the following criteria are not eligible for enrollment and may not be reassessed. Participants are ineligible if they:
• Do not primarily speak English;
• Plan to move from the area during the study period;
• Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher as defined per protocol;
• Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the investigational agent or pose additional risk to the participant;
• Are using tricyclic antidepressants or beta-adrenergic blocker drugs (both oral and topical);
• Have not received the seasonal Flu (Influenza) Vaccine if enrolling December through March.

Where it is running

• Children's National Health System — Washington D.C., District of Columbia, United States
• Ann and Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Johns Hopkins Children's Center: Department of Allergy & Immunology — Baltimore, Maryland, United States
• Henry Ford Health System: Division of Allergy and Immunology — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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