Avanz Phleum Pratense Maintenance Dose

Phase 2

Completed

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Drug: Avanz Phleum pratense; Drug: Placebo

• Registration Number: NCT01438827
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+ (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen induced allergic rhinoconjunctivitis with or without asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• A history of grass pollen allergy
• Positive skin prick test to grass
• Positive Immunoglobulin E test to grass

Exclusion Criteria

• Other allergies overlapping the grass pollen season
• Severe Asthma (defined as a Forced expiratory volume in 1 second (FEV1) below 70 % after adequate treatment)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avanz Phleum pratense 4,000 SQ+	Avanz Phleum pratense	-
Avanz Phleum pratense 15,000 SQ+	Avanz Phleum pratense	-
Injection with no active grass component	Placebo	-

Primary Outcome Measures

Name	Time	Method
Recording of symptomatic allergy medication use	Daily recordings during the grass pollen seasons 2012
Recording of rhinoconjunctivitis symptoms	Daily recordings during the grass pollen season 2012

Trial Locations

Locations (1)

UntersuchungsZentrum für Dermatologie, Allergologie und Asthma; 🇩🇪 Berlin, Germany