Avanz Phleum Pratense Maintenance Dose

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01438827
First received: September 13, 2011
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Allergic Rhinoconjunctivitis
Drug: Avanz Phleum pratense
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Avanz Phleum Pratense Maintenance Dose

Resource links provided by NLM:


Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Recording of rhinoconjunctivitis symptoms [ Time Frame: Daily recordings during the grass pollen season 2012 ] [ Designated as safety issue: No ]
  • Recording of symptomatic allergy medication use [ Time Frame: Daily recordings during the grass pollen seasons 2012 ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Avanz Phleum pratense 15,000 SQ+ Drug: Avanz Phleum pratense
Suspension for Injection, Every 6 weeks for one year
Active Comparator: Avanz Phleum pratense 4,000 SQ+ Drug: Avanz Phleum pratense
Suspension for Injection, Every 6 weeks for one year
Placebo Comparator: Injection with no active grass component Drug: Placebo
Suspension for Injection, Every 6 weeks for one year

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438827

Locations
Germany
UntersuchungsZentrum für Dermatologie, Allergologie und Asthma
Berlin, Germany, 14050
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Principal Investigator: Jörg Kleine-Tebbe, PD Dr. Clinical Research Center for Dermatology, Allergy and Asthma
  More Information

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01438827     History of Changes
Other Study ID Numbers: AV-G-02, AV-G-02
Study First Received: September 13, 2011
Last Updated: January 20, 2014
Health Authority: Austria: Agency for Health and Food Safety
Germany: Paul-Ehrlich-Institut
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014