Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense

NCT01425788 Phase 2 COMPLETED

The purpose of this trial is to investigate the tolerability of Osiris Phleum pratense used with 2 simplified up-dosing schedules compared to the up-dosing schedule used in current practice.

Details

Lead sponsor	ALK-Abelló A/S
Phase	Phase 2
Status	COMPLETED
Enrolment	236
Start date	2011-08
Completion	2012-02

Conditions

• Rhino-conjunctivitis

Interventions

• Osiris Phleum pratense
• Osiris Phleum pratense
• Osiris Phleum pratense

Primary outcomes

• Tolerability based on reporting of adverse events — An average of 42 days per subject
  Recording of adverse events are performed during the entire trial period, from screening to final follow-up contact.

Countries

Poland