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Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense

NCT01489033 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-05-01

No results posted yet for this study

Summary

Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic disease the aim of this study was to assess safety and tolerability of three different subcutaneous immunotherapy dose escalations in patients allergic to the pollen of Phleum pratense.

Conditions

  • Allergic Rhinoconjunctivitis

Interventions

BIOLOGICAL

Subcutaneous immunotherapy with Phleum pratense pollen extract

Increasing doses up to a maximum dose of 500 TSU

Sponsors & Collaborators

  • Roxall Medicina España S.A

    lead INDUSTRY

Principal Investigators

  • Emilio Álvarez-Cuesta, Md, PhD · Hospital Universitario Ramon y Cajal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • Spain

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 NCT01489033 on ClinicalTrials.gov