Sublingual Immunotherapy Studies for Grass and Dust Mite Allergies

NCT01529437 | Completed Phase 1 DMC

• 1 other identifier: 8669
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergies; Allergic Rhinitis; Asthma

Keywords

allergy; immunology; immune tolerance; immunotherapy

Outcome Measures

Primary Outcomes (2)

• Primary Outcome is safety

  We will assess safety outcomes according to GCP/CFR and NIAID guidelines

  2008-2014 (6 years)

• The number of adverse events in the placebo vs the treatment arm will be compared

  Adverse events will be defined by GCP/CFR and by NIAID guidelines.

  2008-2016

Study Arms (2)

Sublingual immunotherapy

ACTIVE COMPARATOR

Subjects will take sublingual immunotherapy who have dust mite and timothy grass allergies

Drug: sublingual immunotherapy

placebo arm

PLACEBO COMPARATOR

The placebo arm will be double blinded and is an important control in SLIT therapies

Drug: sublingual immunotherapy; Drug: placebo sublingual immunotherapy

Interventions

sublingual immunotherapy DRUG

Sublingual immunotherapy is provided in an extract form under IND 13485 and dosed safely through a maintenance dose of 12 months.

Sublingual immunotherapy; placebo arm

placebo sublingual immunotherapy DRUG

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

placebo arm

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pediatric and adult timothy grass- and Dermatophagoides farinae-sensitive subjects with allergic rhinoconjunctivitis with or without asthma perennially or during grass pollen season.
• Subjects must be 5 years of age or older.
• Sensitivity to the relevant allergen will be documented by a positive skin prick test result (see Appendix E for details).
• 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.
• Subjects must be planning to remain in the study area during the trial.
• Subjects and/or their parents must be trained on the proper use of the Epi-Pen to be allowed to enroll in the study.
• Subjects and/or their parents must be mentally and physically capable of self-administering oral drug.

You may not qualify if:

• 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).
• 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.
• 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.
• Subject with an FEV1 or PEF less than 80% predicted (moderate persistent asthma) with or without controller medication.
• 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.
• Subjects who have received timothy grass or dust mite allergen immunotherapy within 3 years prior to admission in this study.
• Subjects who are current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or are taking a beta-blocker (oral or topical).
• Subjects routinely using medication that could induce adverse gastrointestinal reactions during the study.
• Subjects refusing to sign the EpiPen Training Form (see Appendix F).
• Pregnant or breast feeding females.
• Subjects who have any symptoms at dose levels 1 or 2 at the Preliminary Dosing Visit (see, below).
• Subjects with significant pet allergies who have significant exposure at home or at work.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Hypersensitivity; Rhinitis, Allergic; Asthma

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Immunologic; Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Kari Nadeau, MD, PhD

  Stanford University Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 8, 2012
• Study Start: January 1, 2005
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: November 26, 2015

Record last verified: 2015-11

Locations

US (1)