The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions (SCIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital Case Medical Center
Sponsor:
Information provided by (Responsible Party):
Devi Jhaveri, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01878929
First received: May 28, 2013
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Asthma
Allergic Conjunctivitis
Drug: Allergen(Tree, Grass, Weeds)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions: A Double Blind Randomized Control Trial.

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Immediate Reaction Rate of Build-Up Phase in Pollen Season [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    To determine if escalating pollen SCIT doses during the pollen season is associated with an increased rate of immediate reactions in comparison to holding SCIT doses constant.


Secondary Outcome Measures:
  • Delayed Reaction Rate of Build-Up Phase during Pollen Season [ Time Frame: 1 year. ] [ Designated as safety issue: Yes ]
    To determine if escalating pollen SCIT doses during the pollen season is associated with an increased rate of delayed reactions in comparison to holding SCIT doses constant.


Estimated Enrollment: 245
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: Allergen(Tree, Grass, Weeds)
Greer is manufacture of all allergen extract used in this study.
Other Names:
  • "Greer Grass Extract"
  • "Greer Tree Extract"
  • "Greer Ragweed Extract"
  • "Greer Weed Extract"
  • "Greer Tree and Ragweed Extract"
  • "Greer Grass and Ragweed Extract"
  • "Greer Weed and Ragweed Extract"
  • "Greer Tree and Grass Extract"
  • "Greer Weed and Grass Extract"
  • "Greer Weed and Tree Extract"
  • "Greer Tree and Grass and Ragweed Extract"
  • "Greer Grass and Ragweed and Weed Extract"
  • "Greer Tree and Ragweed and Weed Extract"
  • "Greer Tree and Grass and Weed Extract"
  • "Greer Tree and Grass and Ragweed and Weed Extract"
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.

Drug: Allergen(Tree, Grass, Weeds)
Greer is manufacture of all allergen extract used in this study.
Other Names:
  • "Greer Grass Extract"
  • "Greer Tree Extract"
  • "Greer Ragweed Extract"
  • "Greer Weed Extract"
  • "Greer Tree and Ragweed Extract"
  • "Greer Grass and Ragweed Extract"
  • "Greer Weed and Ragweed Extract"
  • "Greer Tree and Grass Extract"
  • "Greer Weed and Grass Extract"
  • "Greer Weed and Tree Extract"
  • "Greer Tree and Grass and Ragweed Extract"
  • "Greer Grass and Ragweed and Weed Extract"
  • "Greer Tree and Ragweed and Weed Extract"
  • "Greer Tree and Grass and Weed Extract"
  • "Greer Tree and Grass and Ragweed and Weed Extract"

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01878929

Contacts
Contact: Devi K Jhaveri, D.O. 2163813333 devi.jhaveri@uhhospitals.org
Contact: Haig Tcheurekdjian, M.D. 2163813333 haig.tcheurekdjian@gmail.com

Locations
United States, Ohio
Allergy/Immunology Associates Inc. Recruiting
South Euclid, Ohio, United States, 44121
Contact: Haig Tcheurekdjian, M.D.    216-381-3333    haig.tcheurekdjian@gmail.com   
Contact: Devi Jhaveri, D.O.    2163813333    devi.jhaveri@uhhospitals.org   
Principal Investigator: Haig Tcheurekdjian, M.D.         
Sponsors and Collaborators
University Hospital Case Medical Center
Investigators
Principal Investigator: Devi K Jhaveri, D.O. University Hospital Case Medical Center
Principal Investigator: Haig Tcheurekdjian, M.D. University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Devi Jhaveri, Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01878929     History of Changes
Other Study ID Numbers: 02-13-06
Study First Received: May 28, 2013
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
pollen
allergen immunotherapy
subcutaneous allergen immunotherapy
SCIT

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 21, 2014