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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01454531
First received: October 13, 2011
Last updated: February 23, 2015
Last verified: February 2015
  Purpose

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


Condition Intervention Phase
Allergic Rhinoconjunctivitis
Drug: AVANZ Phleum pratense
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy

Resource links provided by NLM:


Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Frequency of Subjects With Adverse Drug Reactions [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Frequency of patients with adverse reactions, local or systemic


Secondary Outcome Measures:
  • Frequency of Subjects With Systemic Reactions [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)

  • Frequency of Subjects With Local Adverse Reaction [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Frequency of patients with local adverse reactions

  • Change in Phleum Pratense Specific IgE-blocking Factor [ Time Frame: baseline (visit 1) and at 6 weeks (visit 6) ] [ Designated as safety issue: No ]

    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


  • Change in Phleum Pratense Specific IgG4 [ Time Frame: baseline (visit 1) and at 6 weeks (visit 6) ] [ Designated as safety issue: No ]
  • Change in Immediate Cutaneous Response to Phleum Pratense [ Time Frame: baseline (visit 1) and at 6 weeks (visit 6) ] [ Designated as safety issue: No ]
    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


Enrollment: 199
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVANZ Phleum pratense
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
Drug: AVANZ Phleum pratense
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncontrolled severe asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454531

Locations
Spain
Hospital Nuestra Señora de Sonsoles
Avila, Spain, 05071
Hospital Universitario Infanta Cristina
Badajoz, Spain, 06007
Hospital de Basurto
Bilbao, Spain, 48013
Complejo Hospitalario de Burgos
Burgos, Spain, 09001
H. Campo Arañuelo
Cáceres, Spain, 10300
Hospital Nuestra Señora de La Montaña
Cáceres, Spain, 10004
Hospital Univesitario Fundación Hospital de Alcorcón
Madrid, Spain, 28922
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Infanta Elena
Madrid, Spain, 28342
Hospital Infanta Leonor
Madrid, Spain, 28031
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Fundación Jiménez Diaz
Madrid, Spain, 28025
Hospital Carlos Haya
Malaga, Spain, 29009
Hospital Rio Carrion
Palencia, Spain, 34005
Hospital Santa Bárbara
Puertollano, Spain, 13500
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Univeritario Marques de Valdeilla
Santander, Spain, 39008
Hospital Universitari Politecnic La Fe
Valencia, Spain, 46026
Hospital Santiago Apostol
Vitoria, Spain, 01004
Hospital Virgen de La Concha
Zamora, Spain, 49022
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Principal Investigator: JOAQUIN SASTRE, MD, PhD FUNDACIÓN JIMÉNEZ DIAZ
  More Information

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01454531     History of Changes
Other Study ID Numbers: AV-G-01
Study First Received: October 13, 2011
Results First Received: December 3, 2014
Last Updated: February 23, 2015
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Conjunctivitis
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2015