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OpenTrials
Completed

NCT Number: NCT01454531

An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy

The purpose of this study is to assess the tolerability of AVANZ.

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Key information

Conditions

Allergic Rhinoconjunctivitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital de Basurto, Bilbao, Spain

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About this study

To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of patients with adverse reactions will be the study primary endpoint.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of grass pollen rhinoconjunctivitis
  • Positive SPT to Phleum pratense
  • Positive specific IgE against Phleum pratense

Exclusion criteria

  • Uncontrolled severe asthma

Treatment and study plan

Avanz Phleum pratense

Drug

AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection

Primary outcomes

  1. Frequency of Subjects With Adverse Drug Reactions

    Time frame: 6 weeks

    Frequency of patients with adverse reactions, local or systemic

Secondary outcomes

  1. Frequency of Subjects With Systemic Reactions

    Time frame: 6 weeks

    Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)

  2. Frequency of Subjects With Local Adverse Reaction

    Time frame: 6 weeks

    Frequency of patients with local adverse reactions

  3. Change in Phleum Pratense Specific IgE-blocking Factor

    Time frame: baseline (visit 1) and at 6 weeks (visit 6)

    IgE-blocking factor measures the amount of IgE bound to the allergen in the presence of allergen-competing factors present in the serum of a subject treated with allergen immunotherapy. The test is based in a double IgE measurement, an ordinary assay and an assay in the presence of competing components and takes the form of:

    IgE blocking factor = 1 - (Competitive IgE/Ordinary IgE). Theoretical limits are from 0 (no IgE blocked) to 1 (all IgE blocked) and, being a ratio, is a dimensionless measure

  4. Change in Phleum Pratense Specific IgG4

    Time frame: baseline (visit 1) and at 6 weeks (visit 6)

  5. Change in Immediate Cutaneous Response to Phleum Pratense

    Time frame: baseline (visit 1) and at 6 weeks (visit 6)

    Wheal size provoked after prick test with 4, 20 and 100 µg/ml Phl p 5 allergen extracts analysed by Parallel Line Assay. Cutaneous Tolerance Index (CTI) is the factor it is necessary to multiply the extract concentration by after SCIT (V6) to obtain the same response in terms of wheal area as at baseline (V1). CTI, being an index, is a dimensionless measure. A CTI of 1 indicates no change in skin sensitivity while if higher than 1 a decrease in skin sensitivity (it would be needed a more concentrated allergen extract at V6 to elicit the same skin response as at V1

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 19, 2011
Registry last updated
Mar 6, 2015

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

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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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