The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions

NCT01878929 | Unknown Phase 1

• 1 other identifier: 02-13-06
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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

Keywords

pollen; allergen immunotherapy; subcutaneous allergen immunotherapy; SCIT

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Delayed Reaction Rate of Build-Up Phase during Pollen Season

  1 year.

Study Arms (2)

Allergen(Tree, Grass, Weeds) -Held

ACTIVE COMPARATOR

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)

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

ACTIVE COMPARATOR

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)

Interventions

Allergen(Tree, Grass, Weeds) DRUG

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

Also known as: "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"

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

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

Allergy/Immunology Associates Inc.

South Euclid, Ohio, 44121, United States

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma; Conjunctivitis, Allergic

Interventions

nabiximols

Condition Hierarchy (Ancestors)

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

Study Officials

• Devi K Jhaveri, D.O.

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Haig Tcheurekdjian, M.D.

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devi K Jhaveri, D.O.

CONTACT

2163813333; devi.jhaveri@uhhospitals.org

Haig Tcheurekdjian, M.D.

CONTACT

2163813333; haig.tcheurekdjian@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 17, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

US (1)