MedTrace Logo

Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma

NCT01634958 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2013-11-19

No results posted yet for this study

Summary

Specific immunotherapy for IgE mediated sensitization to grass pollen

4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the optimum dose.

Conditions

  • Allergic Rhinitis/Rhinoconjunctivitis +- Intermittent Asthma
  • Sensitization Against Phleum Pratense Pollen
  • Dose-Finding Study

Interventions

BIOLOGICAL

Depigoid Phleum

Suspension for subcutaneous injection Build-up phase (day 1): 0,1mL + 0,2mL + 0,2mL s.c.injections in intervals of 30 minutes Maintenance phase: 5x single s.c. injection of 0,5mL every 4 weeks

Sponsors & Collaborators

  • Leti Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Oliver Pfaar, PD Dr. med. · Centre for Rhinology and Allergology of University Hospital Mannheim

  • Angelika Sager, Dr. med. · Leti Pharma GmbH

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • Germany

Study Locations

More Related Trials

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 NCT01634958 on ClinicalTrials.gov