NCT01353755

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

Randomised Double Blind Placebo Controlled Pivotal Study to Evaluate Efficacy and Safety of rPhleum in Adult and Adolescent Patients Suffering From Rhinoconjunctivitis +/- Controlled Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Allergopharma GmbH & Co. KG · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-08-01
• Completion: 2014-09-01
• First posted: 2011-05-16
• Last updated: 2014-11-13

Locations

1 site across 1 country: Germany