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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

September 13, 2011
January 20, 2014
September 2011
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01438827 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Avanz Phleum Pratense Maintenance Dose
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Rhinoconjunctivitis
  • Drug: Avanz Phleum pratense
    Suspension for Injection, Every 6 weeks for one year
  • Drug: Placebo
    Suspension for Injection, Every 6 weeks for one year
  • Active Comparator: Avanz Phleum pratense 15,000 SQ+
    Intervention: Drug: Avanz Phleum pratense
  • Active Comparator: Avanz Phleum pratense 4,000 SQ+
    Intervention: Drug: Avanz Phleum pratense
  • Placebo Comparator: Injection with no active grass component
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
January 2013
December 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01438827
AV-G-02, AV-G-02
Not Provided
ALK-Abelló A/S
ALK-Abelló A/S
Not Provided
Principal Investigator: Jörg Kleine-Tebbe, PD Dr. Clinical Research Center for Dermatology, Allergy and Asthma
ALK-Abelló A/S
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP