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Completed

NCT Number: NCT00857779

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

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

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Key information

Conditions

Rhinitis Asthma Bronchial Diseases Conjunctival Diseases Conjunctivitis Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allergists' practice Dr. Kirsten Jung

Erfurt, Thuringia, D-99084, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

subcutaneous immunotherapy

Biological

7 injections

Other names: AVANZ

Primary outcomes

  1. IgE-blocking factor

    Time frame: start of treatment and 1 week after end of treatment

Secondary outcomes

  1. Tolerability of two different updosing schedules

    Time frame: throughout treatment

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 9, 2009
Registry last updated
Feb 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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