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 15, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2011

Last Updated Date

January 15, 2013

Start Date ^ICMJE

September 2011

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01438827 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Avanz Phleum Pratense Maintenance Dose

Official Title ^ICMJE

Avanz Phleum Pratense Maintenance Dose

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Allergic Rhinoconjunctivitis

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

450

Completion Date

January 2013

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01438827

Other Study ID Numbers ^ICMJE

AV-G-02, AV-G-02

Has Data Monitoring Committee

Not Provided

Responsible Party

ALK-Abelló A/S

Study Sponsor ^ICMJE

ALK-Abelló A/S

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jörg Kleine-Tebbe, PD Dr.

Clinical Research Center for Dermatology, Allergy and Asthma

Information Provided By

ALK-Abelló A/S

Verification Date

January 2013

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

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