Observational study in allergic patients to treating hay fever against grass pollen.Patient reported outcome in patients treated with various doses of Depigoid Phleum.

Phase 1

• Conditions: Allergic rhinitis/rhinoconjunctivitis with or without concomitant asthma due to grass pollen allergy; MedDRA version: 14.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; MedDRA version: 14.1Level: LLTClassification code 10001705Term: Allergic asthmaSystem Organ Class: 100000004855; MedDRA version: 14.1Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-004920-12-CZ
• Lead Sponsor: ETI Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-11
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

· Written informed consent
· Allergic rhinitis/rhinoconjunctivitis with or without concomitant asthma due to grass pollen allergy
· Treatment with one of 4 concentrations of Depigoid Phleum (100, 1000, 5000 and 10000 DPP/ml) in the period from October 2012 until April 2013.
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 266
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

· Less than 4 applications of 0,5 ml of one of 4 concentrations of Depigoid Phleum (100, 1000, 5000 and 10000 DPP/ml) between October 2012 and April 2013

Study & Design

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