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Safety Clinical Trial With Depigopid 50% Grasses/50% Olea Europaea(2000DPP/ml) or Depigoid 50% Grasses/50% Parietaria Judaica(2000DPP/ml).

Allergy Clinical Trial

Official title:
Prospective, Open Uncontrolled Study to Evaluate the Safety of Depigoid With Two Pollen Combinations (Grasses/Olea and Grasses/Parietaria)2000DPP/ml in Patients With Allergic Rhinitis or Rhinoconjunctivitis With or Without Seasonal Asthma.

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later.

Clinical Trial Description

The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later. The treatment period consists, thus, of 4 weeks.

Primary variable:

•Number of subjects [%] suffering at least one immediate or delayed systemic reaction of grade 2 or higher during the 4-weeks treatment period [grading according to the 2006 EAACI standards ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01734265
Study type Interventional
Source Laboratorios Leti, S.L.
Contact
Status Completed
Phase Phase 2
Start date November 2012
Completion date April 2013
View Details
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