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

Primary Purpose

Allergic Rhinitis, Asthma, Allergic Conjunctivitis

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Allergen(Tree, Grass, Weeds)
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring pollen, allergen immunotherapy, subcutaneous allergen immunotherapy, SCIT

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Allergy/Immunology Associates Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Allergen(Tree, Grass, Weeds) -Held

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Immediate Reaction Rate of Build-Up Phase in Pollen Season
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
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.

Full Information

First Posted
May 28, 2013
Last Updated
June 12, 2013
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01878929
Brief Title
The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions
Acronym
SCIT
Official Title
The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions: A Double Blind Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Specific Aim 1: 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. Hypothesis: There will not be an increased rate of immediate reactions to SCIT in build up phase received during the pollen season in comparison to SCIT held for pollen season. Strategy: In a prospective trial, 245 subjects will be randomized to receive monthly (doses held constant) or weekly (doses built up) injections. Rate of immediate local and systemic reactions per injection will be compared between the two groups. Specific Aim 2: 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. Hypothesis: There will not be an increased rate of delayed reactions to SCIT in build up phase received during the pollen season in comparison to SCIT held for pollen season. Strategy: In a prospective trial, 245 subjects will be randomized to receive monthly (doses held constant) or weekly (doses built up) injections. Rate of delayed reactions per injection will be compared between the two groups. BACKGROUND AND SIGNIFICANCE Immunotherapy is one of the most effective therapies for allergic rhinoconjunctivitis, but the protocol dosing during pollen season is based on limited data. Immunotherapy is given in increasing dosage during the build up phase in order to build tolerance. After the build up phase, there is a maintenance phase that is used for the remainder of therapy. At this time, there is little data to support the common practice of not increasing the dosage of immunotherapy during pollen seasons. The recent allergen immunotherapy practice parameter references 2 articles that have noted no increased systemic reactions to SCIT during pollen season. , In one prospective study, it was concluded that there was no direct correlation of reactions to SCIT and pollen season.3 They did note a correlation between the mean monthly mold counts in August to October and the rate of systemic reactions. The other study referenced is a prospective study which did not observe a statistically significant difference in the rate of systemic reactions to grass or ragweed pollen during their respective pollen seasons.4 However, the conclusions of these studies are conflicted by another study which consists of surveys retrospectively sent to members of the American Academy of Allergy Asthma and Immunology. The surveys in this study identified 46% of near fatal reactions to SCIT as occurring during peak allergy season. Though the immunotherapy standard parameters are not defining pollen season as a contraindication, we will consider it more that minimal risk for this study. It is still common practice to stop the buildup phase and not escalate SCIT dosing during pollen season due to the conflicting available data and limitations in study design of many of the studies (retrospective, questionnaire based). A further look into SCIT dosing during pollen season will allow for more standardized practice and potentially improved patient outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Asthma, Allergic Conjunctivitis
Keywords
pollen, allergen immunotherapy, subcutaneous allergen immunotherapy, SCIT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
245 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allergen(Tree, Grass, Weeds) -Held
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Allergen(Tree, Grass, Weeds) -Build-up
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Allergen(Tree, Grass, Weeds)
Other Intervention Name(s)
"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"
Intervention Description
Greer is manufacture of all allergen extract used in this study.
Primary Outcome Measure Information:
Title
Immediate Reaction Rate of Build-Up Phase in Pollen Season
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Delayed Reaction Rate of Build-Up Phase during Pollen Season
Description
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.
Time Frame
1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: are in maintenance phase of SCIT are on beta-blockers have a forced expiratory volume in 1 second (FEV1) of less than 70% of predicted 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) have any uncontrolled cardiac or pulmonary disease as determined by their treating allergist/immunologist are pregnant, due to risk of harm to fetus if anaphylaxis occurs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Devi K Jhaveri, D.O.
Phone
2163813333
Email
devi.jhaveri@uhhospitals.org
First Name & Middle Initial & Last Name or Official Title & Degree
Haig Tcheurekdjian, M.D.
Phone
2163813333
Email
haig.tcheurekdjian@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devi K Jhaveri, D.O.
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haig Tcheurekdjian, M.D.
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy/Immunology Associates Inc.
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haig Tcheurekdjian, M.D.
Phone
216-381-3333
Email
haig.tcheurekdjian@gmail.com
First Name & Middle Initial & Last Name & Degree
Devi Jhaveri, D.O.
Phone
2163813333
Email
devi.jhaveri@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Haig Tcheurekdjian, M.D.

12. IPD Sharing Statement

Learn more about this trial

The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions

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