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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00857779
Other study ID # AF-H-01
Secondary ID
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


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
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