Assessment of the Effectiveness of a Dermatophagoides Pteronyssinus Extract, Rated in Units of Mass and Administered Subcutaneously for the Treatment of Local Allergic Rhinitis. Randomized, Double-blind, Placebo-controlled Study. (ECRL1)

NCT02123316 Phase 2 COMPLETED

To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in symptom scores and medication use in the active group compared to placebo. The influence of treatment in "in vitro" and "in vivo" objective parameters was also assessed.

Details

Lead sponsor	Miguel Blanca Gomez
Phase	Phase 2
Status	COMPLETED
Enrolment	36
Start date	2010-01
Completion	2014-04

Conditions

• Local Allergic Rhinitis

Interventions

• Pangramin Plus D. pteronyssinus
• Placebo

Primary outcomes

• Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months — Baseline, month 1,3,6,12,18, and 24
  Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 consecutive weeks. Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe). The use of rescue medication was recorded in the patient diary according to the following score: Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).

Countries

Spain