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A Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine

NCT01740284 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2013-02-08

No results posted yet for this study

Summary

Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment.

The majority are local allergic reactions within the mouth and/or throat, and most of these reactions are mild or moderate. It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment. So this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions.

Conditions

  • Allergic Rhinoconjunctivitis

Interventions

DRUG

Grazax + Aerius

DRUG

Grazax + placebo

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Germany

Study Locations

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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 NCT01740284 on ClinicalTrials.gov