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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01529437
First received: January 30, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Allergies
Allergic Rhinitis
Asthma
Drug: sublingual immunotherapy
Drug: placebo sublingual immunotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

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

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


Enrollment: 31
Study Start Date: January 2005
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

SUBJECT INCLUSION CRITERIA:

  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.

SUBJECT EXCLUSION CRITERIA:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529437

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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01529437     History of Changes
Other Study ID Numbers: 8669
Study First Received: January 30, 2012
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
allergy
immunology
immune tolerance
immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Asthma
Rhinitis
Rhinitis, Allergic, Perennial
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 25, 2014