Phase II, Multicenter, Randomized, Double-blind Study, With Subcutaneous Immunotherapy, in Parallel Groups and Placebo-controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Dermatophagoides Pteronyssinus.

NCT01564017 Phase 2 COMPLETED

As part of the registration plan of our products and after performing a Phase I study the present trial has been designed to compare the efficacy of 5 different doses of subcutaneous immunotherapy in depot presentation.

Details

Lead sponsor	Roxall Medicina España S.A
Phase	Phase 2
Status	COMPLETED
Enrolment	150
Start date	2012-05
Completion	2013-05

Conditions

• Allergic Rhinoconjunctivitis

Interventions

• Allergovac depot
• Allergovac depot
• Allergovac depot
• Allergovac depot
• Allergovac depot
• Allergovac depot

Primary outcomes

• Changes in nasal provocation test — from baseline (V0) to final visit (VF 18 weeks after randmization)
  Variation of the concentration of DPT extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). The changes will be compared among groups (including the placebo group).

Countries

Spain