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Sublingual Immunotherapy Studies for Grass and Dust Mite Allergies (SLIT)

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. Identifier: NCT01529437
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : November 26, 2015
Information provided by (Responsible Party):
Kari Christine Nadeau, Stanford University

Brief Summary:
This is a study for children and adults who are interested in a new therapy for their allergies to dust mite and timothy grass. The new therapy is called sublingual immunotherapy and the investigators are testing if it is safe and well tolerated.

Condition or disease Intervention/treatment Phase
Allergies Allergic Rhinitis Asthma Drug: sublingual immunotherapy Drug: placebo sublingual immunotherapy Phase 1

Detailed Description:
This is a phase I, single-center, randomized, placebo-controlled study of sublingual immunotherapy (SLIT) in pediatric and adult subjects with both house dust mite (HDM) and timothy grass (TG) allergies. We will evaluate whether Dermatophagoides farinae (DF) and/or TG allergen SLIT is safe in children and adults. We will also determine whether treatment with DF and/or TG SLIT reduces the severity of allergic symptoms (allergic rhinitis, allergic conjunctivitis) and enhances their resolution. The study will also evaluate whether SLIT provides a robust durability of response once it is terminated. The dosing-phase of the study will last up to 12 months. In addition, a follow up period of 2 years will occur. Approximately 10 subjects will be on placebo, and 20 on active treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Single Center, Randomized, Controlled Study Using Sublingual Immunotherapy for Timothy Grass and Dust Mite Allergies
Study Start Date : January 2005
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Sublingual immunotherapy
Subjects will take sublingual immunotherapy who have dust mite and timothy grass allergies
Drug: sublingual immunotherapy
Sublingual immunotherapy is provided in an extract form under IND 13485 and dosed safely through a maintenance dose of 12 months.

Placebo Comparator: placebo arm
The placebo arm will be double blinded and is an important control in SLIT therapies
Drug: sublingual immunotherapy
Sublingual immunotherapy is provided in an extract form under IND 13485 and dosed safely through a maintenance dose of 12 months.

Drug: placebo sublingual immunotherapy
SLIT placebo will be the same color and consistency of the active drug arm to provide double blinding

Primary Outcome Measures :
  1. Primary Outcome is safety [ Time Frame: 2008-2014 (6 years) ]
    We will assess safety outcomes according to GCP/CFR and NIAID guidelines

  2. The number of adverse events in the placebo vs the treatment arm will be compared [ Time Frame: 2008-2016 ]
    Adverse events will be defined by GCP/CFR and by NIAID guidelines.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  1. Pediatric and adult timothy grass- and Dermatophagoides farinae-sensitive subjects with allergic rhinoconjunctivitis with or without asthma perennially or during grass pollen season.
  2. Subjects must be 5 years of age or older.
  3. Sensitivity to the relevant allergen will be documented by a positive skin prick test result (see Appendix E for details).
  4. All female subjects of child-bearing potential will be required to provide a urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.
  5. Subjects must be planning to remain in the study area during the trial.
  6. Subjects and/or their parents must be trained on the proper use of the Epi-Pen to be allowed to enroll in the study.
  7. Subjects and/or their parents must be mentally and physically capable of self-administering oral drug.


No absolute contraindications to allergen skin testing and/or sublingual immunotherapy are known. However, the risk of serious systemic anaphylactic reactions to pollen or any potent allergenic extract suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).

  1. Subjects having a history of unexplained anaphylaxis within 2 years or a history of multiple (≥2) episodes of anaphylaxis in the past year, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma. Anaphylaxis must be medically diagnosed.
  2. Subjects with unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that in the mind of the investigator might interfere with the evaluation or administration of the test drug or pose additional risk to the subject e.g. gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease.
  3. Subject with an FEV1 or PEF less than 80% predicted (moderate persistent asthma) with or without controller medication.
  4. Subjects who have received an experimental drug in the last 30 days prior to admission into this study or who plan to use an experimental drug during the study.
  5. Subjects who have received timothy grass or dust mite allergen immunotherapy within 3 years prior to admission in this study.
  6. Subjects who are current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or are taking a beta-blocker (oral or topical).
  7. Subjects routinely using medication that could induce adverse gastrointestinal reactions during the study.
  8. Subjects refusing to sign the EpiPen Training Form (see Appendix F).
  9. Pregnant or breast feeding females.
  10. Subjects who have any symptoms at dose levels 1 or 2 at the Preliminary Dosing Visit (see, below).
  11. Subjects with significant pet allergies who have significant exposure at home or at work.

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 identifier (NCT number): NCT01529437

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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: Kari Nadeau, MD, PhD Stanford University Faculty

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Responsible Party: Kari Christine Nadeau, Principle Investigator, Stanford University Identifier: NCT01529437     History of Changes
Other Study ID Numbers: 8669
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015
Keywords provided by Kari Christine Nadeau, Stanford University:
immune tolerance
Additional relevant MeSH terms:
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Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Immune System Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs