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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014