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The Effect of Pollen Season on Subcutaneous Allergen Immunotherapy Reactions

NCT01878929 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2013-06-17

No results posted yet for this study

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

Interventions

DRUG

Allergen(Tree, Grass, Weeds)

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

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Devi K Jhaveri, D.O. · University Hospitals Cleveland Medical Center

  • Haig Tcheurekdjian, M.D. · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01878929 on ClinicalTrials.gov