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2nd Pivotal Study rPhleum - Adults and Adolescents With Rhinoconjunctivitis +/-Controlled Asthma

NCT01353755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2014-11-13

No results posted yet for this study

Summary

To evaluate efficacy and tolerability of specific subcutaneous immunotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with rhinoconjunctivitis caused by grass pollen with/without controlled asthma.

Conditions

  • Rhinoconjunctivitis
  • Allergic Asthma

Interventions

DRUG

Grass pollen specific immunotherapy

* Strength 1 (0.78μg/mL) * Strength 2 (6.25μg/mL) * Strength 3 (50μg/mL) * Strength 4 (200μg/mL) The subcutaneous injections will be administered at intervals of 7 (+ 7 days)during up-titration. For maintenance the injection intervals are prolonged to 4 weeks (+2). The double blind treatment period is 2 years, followed by 1 year open-label treatment for patients previously treated with verum and 3 years open-label treatment for patients previously recieved placebo.

DRUG

Placabo

Placebo will be administered in the same way as the test product. Placebo will be identical in terms of appearance to the IMP.

Sponsors & Collaborators

  • Allergopharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Nicolas Hunzelmann, Prof. Dr.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-08-31
Completion
2014-09-30

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 NCT01353755 on ClinicalTrials.gov