NCT00666341

Brief Summary

Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

1.3 years

First QC Date

April 21, 2008

Last Update Submit

November 7, 2013

Conditions

Type I-Allergy

Outcome Measures

Primary Outcomes (1)

  • Systemic reaction (according to Tryba)

    Number of patients with at least one systemic reaction (according to Tryba Grade 1-4) with possible, probable or definite relationship to the study medication determined at the end of the uptitration phase.

    uptitration phase

Secondary Outcomes (1)

  • Late Phase Reactions

    before and at the end of the double-blind phase

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.

Drug: placebo

20 μg rPhleum Immunotherapy

EXPERIMENTAL

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)

Biological: rPhleum

40 μg rPhleum Immunotherapy

EXPERIMENTAL

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)

Biological: rPhleum

80 μg rPhleum Immunotherapy

EXPERIMENTAL

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)

Biological: rPhleum

120 μg rPhleum Immunotherapy

EXPERIMENTAL

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)

Biological: rPhleum

Interventions

placeboDRUG

Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.

Also known as: Comparator
Placebo
rPhleumBIOLOGICAL

Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)

Also known as: Specific Immunotherapy
20 μg rPhleum Immunotherapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • main symptoms of allergic rhinitis/rhinoconjunctivitis with or without controlled asthma against grass pollen allergens
  • positive SPT
  • positive EAST
  • positive specific provocation test

You may not qualify if:

  • serious chronic diseases
  • other perennial allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. med. Ludger Klimek

Wiesbaden, Baden-W., 68167, Germany

Location

Related Links

Study Officials

  • Karl Hörmann, MD

    Universitätsklinikum Mannheim GMBH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 24, 2008

Study Start

September 1, 2007

Primary Completion

January 1, 2009

Study Completion

May 1, 2010

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations

DE(1)