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

February 23, 2015 updated by: ALK-Abelló A/S
The purpose of this study is to assess the tolerability of AVANZ.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Avila, Spain, 05071
        • Hospital Nuestra Senora de Sonsoles
      • Badajoz, Spain, 06007
        • Hospital Universitario Infanta Cristina
      • Bilbao, Spain, 48013
        • Hospital de Basurto
      • Burgos, Spain, 09001
        • Complejo Hospitalario de Burgos
      • Cáceres, Spain, 10004
        • Hospital Nuestra Señora de La Montaña
      • Cáceres, Spain, 10300
        • H. Campo Arañuelo
      • Madrid, Spain, 28031
        • Hospital Infanta Leonor
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28025
        • Fundación Jiménez Díaz
      • Madrid, Spain, 28342
        • Hospital Infanta Elena
      • Madrid, Spain, 28922
        • Hospital Univesitario Fundación Hospital de Alcorcón
      • Malaga, Spain, 29009
        • Hospital Carlos Haya
      • Palencia, Spain, 34005
        • Hospital Río Carrión
      • Puertollano, Spain, 13500
        • Hospital Santa Bárbara
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Santander, Spain, 39008
        • Hospital Univeritario Marques de Valdeilla
      • Valencia, Spain, 46026
        • Hospital Universitari Politecnic La Fe
      • Vitoria, Spain, 01004
        • Hospital Santiago Apostol
      • Zamora, Spain, 49022
        • Hospital Virgen de la Concha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncontrolled severe asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AVANZ Phleum pratense
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Subjects With Adverse Drug Reactions
Time Frame: 6 weeks
Frequency of patients with adverse reactions, local or systemic
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 weeks
Frequency of Subjects With Local Adverse Reaction
Time Frame: 6 weeks
Frequency of patients with local adverse reactions
6 weeks
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

baseline (visit 1) and at 6 weeks (visit 6)
Change in Phleum Pratense Specific IgG4
Time Frame: baseline (visit 1) and at 6 weeks (visit 6)
baseline (visit 1) and at 6 weeks (visit 6)
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
baseline (visit 1) and at 6 weeks (visit 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: JOAQUIN SASTRE, MD, PhD, Fundación Jiménez Díaz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

October 17, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

February 23, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • AV-G-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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