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A Trial of the ALK Grass Tablet in Subjects With Hayfever

Primary Purpose

Allergy

Status

Completed

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

ALK Grass tablet

About this trial

This is an interventional treatment trial for Allergy focused on measuring Grass pollen allergy, Hayfever, Allergen immunotherapy, Specific immunotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligibility Criteria: A history of grass pollen induced rhinoconjunctivitis Positive skin prick test to grass Positive specific IgE to grass

Sites / Locations

Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Recording of rhinoconjunctivitis symptoms

Recording of use of rescue medication

Secondary Outcome Measures

Quality of life

Full Information

NCT ID

NCT00227279

First Posted

September 26, 2005

Last Updated

January 28, 2013

Sponsor

ALK-Abelló A/S

1. Study Identification

Unique Protocol Identification Number

NCT00227279

Brief Title

A Trial of the ALK Grass Tablet in Subjects With Hayfever

Official Title

A Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of ALK Grass Tablet in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ALK-Abelló A/S

4. Oversight

5. Study Description

Brief Summary

This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergy

Keywords

Grass pollen allergy, Hayfever, Allergen immunotherapy, Specific immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

634 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

ALK Grass tablet

Intervention Description

Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years

Primary Outcome Measure Information:

Title

Recording of rhinoconjunctivitis symptoms

Time Frame

Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009

Title

Recording of use of rescue medication

Time Frame

Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009

Secondary Outcome Measure Information:

Title

Quality of life

Time Frame

Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligibility Criteria: A history of grass pollen induced rhinoconjunctivitis Positive skin prick test to grass Positive specific IgE to grass

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bente Tholstrup, MSc

Organizational Affiliation

ALK-Abello A/S

Official's Role

Study Director

Facility Information:

Facility Name

Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital

City

Aarhus C

ZIP/Postal Code

8000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

16890769

Citation

Dahl R, Kapp A, Colombo G, de Monchy JG, Rak S, Emminger W, Rivas MF, Ribel M, Durham SR. Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2006 Aug;118(2):434-40. doi: 10.1016/j.jaci.2006.05.003.

Results Reference

result

PubMed Identifier

17620075

Citation

Durham SR, Riis B. Grass allergen tablet immunotherapy relieves individual seasonal eye and nasal symptoms, including nasal blockage. Allergy. 2007 Aug;62(8):954-7. doi: 10.1111/j.1398-9995.2007.01402.x.

Results Reference

result

PubMed Identifier

17620076

Citation

Calderon MA, Birk AO, Andersen JS, Durham SR. Prolonged preseasonal treatment phase with Grazax sublingual immunotherapy increases clinical efficacy. Allergy. 2007 Aug;62(8):958-61. doi: 10.1111/j.1398-9995.2007.01416.x.

Results Reference

result

PubMed Identifier

18155284

Citation

Dahl R, Kapp A, Colombo G, de Monchy JG, Rak S, Emminger W, Riis B, Gronager PM, Durham SR. Sublingual grass allergen tablet immunotherapy provides sustained clinical benefit with progressive immunologic changes over 2 years. J Allergy Clin Immunol. 2008 Feb;121(2):512-518.e2. doi: 10.1016/j.jaci.2007.10.039. Epub 2007 Dec 26.

Results Reference

result

Learn more about this trial

A Trial of the ALK Grass Tablet in Subjects With Hayfever

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