Recruiting
Phase 1
Phase 2

Allergen Immunotherapy

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT01878929

Conditions

Allergic Rhinitis

Asthma

Allergic Conjunctivitis

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Interventions

Allergen(Tree, Grass, Weeds)

Study Details

Brief summary:

Subcutaneous allergen immunotherapy (SCIT) is a widely used and effective treatment modality for allergic rhinoconjunctivitis and asthma. SCIT starts with a build-up phase during which a patient receives frequent, escalating doses of the allergens they are allergic to until they reach a predetermined maintenance dose. This is followed by a maintenance phase during which the allergen dose is kept constant and administered at greater intervals. Maximum clinical improvement is generally not seen until a patient is in the maintenance phase. Anecdotal evidence of possible reactions to SCIT administered during a patient's pollen season has led to dosage freezes during a patient's pollen season which extends the length of the build-up phase by many months. Prolonging the buildup phase increases the time required to obtain maximal benefit from SCIT, and at the same time, can decrease patient compliance with therapy due to the prolonged period of time when frequent injections are required.

The aims of this study are to determine if adverse reactions to pollen SCIT are increased if doses are increased during pollen season.

Conditions

Allergic Rhinitis

Asthma

Allergic Conjunctivitis

Study ID

NCT01878929

Start date

Apr, 2013

Status verified date

Jun, 2013

Completion date

Apr, 2014

Anticipated

Primary completion date

Apr, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • include individuals ages 5 and greater at Allergy/Immunology Associates, Inc., who are receiving build-up SCIT to tree, grass, and/or weed pollens for allergic rhinitis, allergic conjunctivitis, and/or asthma

Exclusion Criteria:

1. are in maintenance phase of SCIT
2. are on beta-blockers
3. have a forced expiratory volume in 1 second (FEV1) of less than 70% of predicted
4. have a history of anaphylaxis with previous SCIT to aeroallergens (as defined by the requirement of intramuscular or subcutaneous epinephrine for treatment of a SCIT-induced reaction)
5. have any uncontrolled cardiac or pulmonary disease as determined by their treating allergist/immunologist
6. are pregnant, due to risk of harm to fetus if anaphylaxis occurs.

Study Design

Enrollment

245 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Allergen(Tree, Grass, Weeds) -Held

Allergen(Tree, Grass, Weeds)-Held

Weekly administration of Greer manufactured allergen extract at same dose and concentration patient was on prior to allergen season for the duration of patients allergen season.

active comparator: Allergen(Tree, Grass, Weeds) -Build-up

Allergen(Tree, Grass, Weeds) -Build-up

Weekly administration of Greer manufactured allergen extract at escalating dose and concentration patient for the duration of patients allergen season.

Interventions

Allergen(Tree, Grass, Weeds)

Greer is manufacture of all allergen extract used in this study.

Primary outcome measure

  • Immediate Reaction Rate of Build-Up Phase in Pollen Season [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Devi K Jhaveri, D.O.

2163813333devi.jhaveri@uhhospitals.org

Haig Tcheurekdjian, M.D.

2163813333haig.tcheurekdjian@gmail.com

Locations

Allergy/Immunology Associates Inc.

Recruiting

South Euclid, Ohio, United States, 44121

Contacts

Haig Tcheurekdjian, M.D.

216-381-3333haig.tcheurekdjian@gmail.com

Devi Jhaveri, D.O.

2163813333devi.jhaveri@uhhospitals.org

Principal Investigator:

Haig Tcheurekdjian, M.D.

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jun 17, 2013

Last verified

Jun, 2013

Keywords

  • pollen
  • allergen immunotherapy
  • subcutaneous allergen immunotherapy
  • SCIT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2013-06-17.