Avanz Phleum Pratense Maintenance Dose

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.

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Key information

Conditions

Allergic Rhinoconjunctivitis

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UntersuchungsZentrum für Dermatologie, Allergologie und Asthma

Berlin, State of Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Avanz Phleum pratense

Drug

Suspension for Injection, Every 6 weeks for one year

Placebo

Drug

Suspension for Injection, Every 6 weeks for one year

Primary outcomes

Recording of rhinoconjunctivitis symptoms

Time frame: Daily recordings during the grass pollen season 2012
Recording of symptomatic allergy medication use

Time frame: Daily recordings during the grass pollen seasons 2012

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2013
First posted: Sep 22, 2011
Registry last updated: Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed