Avanz Phleum Pratense Maintenance Dose

Allergic Rhinoconjunctivitis Clinical Trial

Official title:

Avanz Phleum Pratense Maintenance Dose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438827
• Other study ID #: AV-G-02
• Secondary ID: AV-G-02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2011
• Last updated: January 20, 2014
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2014
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyGermany: Paul-Ehrlich-InstitutSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Avanz Phleum pratense
Suspension for Injection, Every 6 weeks for one year
• Placebo
Suspension for Injection, Every 6 weeks for one year

Locations

Country	Name	City	State
Germany	UntersuchungsZentrum für Dermatologie, Allergologie und Asthma	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording of rhinoconjunctivitis symptoms		Daily recordings during the grass pollen season 2012	No
Primary	Recording of symptomatic allergy medication use		Daily recordings during the grass pollen seasons 2012	No