ot applicable

Phase 1

• Conditions: Treatment of grass pollen induced rhinitis and conjunctivitis in adult patients with clinically relevant symptoms and diagnosed witha positive skin-prick test and / or specific IgE test to grass pollen.; MedDRA version: 15.1Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-005092-14-ES
• Lead Sponsor: ALK-Abelló S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.A history of relevant rhinitis or rhinoconjunctivitis with or without asthma due to grass pollen since at least the pollen season prior to trial entry (GPS 2012).
2.Documented positive specific IgE against Phl p 5 (above or equal to IgE Class 2, above or equal to 0.70 kU/l).
3.Positive Skin Prick Test (SPT) response (wheal diameter above or equal 3 mm) to Phleum pratense (ALK-Abelló).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous treatment by immunotherapy with grass allergen extracts.
2.Ongoing treatment with any allergen specific immunotherapy product.
3.Previous or ongoing treatment with Omalizumab, mono amine oxidase (MAO) inhibitors or tricyclic antidepressant medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified