We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Avanz Phleum Pratense Maintenance Dose

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438827
First Posted: September 22, 2011
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ALK-Abelló A/S
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
  • Recording of symptomatic allergy medication use [ Time Frame: Daily recordings during the grass pollen seasons 2012 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01438827     History of Changes
Other Study ID Numbers: AV-G-02
First Submitted: September 13, 2011
First Posted: September 22, 2011
Last Update Posted: January 22, 2014
Last Verified: January 2014

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