Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients

Asthma Clinical Trial

Official title:

A Multicentre Randomised Phase II Clinical Trial to Demonstrate Equivalent Pharmacodynamic Efficacy and Tolerability of Two Updosing Schedules for ALK-Flex SQ

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857779
• Other study ID #: AF-H-01
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2009
• Last updated: February 7, 2013
• Start date: February 2009
• Est. completion date: October 2009

Study information

• Verified date: February 2013
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season

• Lack of adequate relief with symptomatic medication during the previous grass pollen season

• Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter >= 3mm) currently performed or not older than 60 days before screening

Exclusion Criteria:

• FEV1 < 70% of predicted value at screening

• Bronchial asthma corresponding to GINA step 3 or more, even if controlled

• History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months

• Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years

• Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Conjunctivitis
• Rhinitis

Intervention

Biological:
• subcutaneous immunotherapy
7 injections

Locations

Country	Name	City	State
Germany	Allergists` practice Dr. Kirsten Jung	Erfurt	Thueringen

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pfaar O, Jung K, Wolf H, Decot E, Kleine-Tebbe J, Klimek L, Wüstenberg E. Immunological effects and tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with optimized allergen/adjuvant ratio. Allergy. 2012 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgE-blocking factor		start of treatment and 1 week after end of treatment	No
Secondary	Tolerability of two different updosing schedules		throughout treatment	Yes