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

Allergic Rhinoconjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454531
• Other study ID #: AV-G-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 13, 2011
• Last updated: February 23, 2015
• Start date: June 2011
• Est. completion date: April 2012

Study information

• Verified date: February 2015
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• History of grass pollen rhinoconjunctivitis

• Positive SPT to Phleum pratense

• Positive specific IgE against Phleum pratense

Exclusion Criteria:

• Uncontrolled severe asthma

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis, Allergic

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Nuestra Señora de Sonsoles	Avila
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Hospital de Basurto	Bilbao
Spain	Complejo Hospitalario de Burgos	Burgos
Spain	H. Campo Arañuelo	Cáceres
Spain	Hospital Nuestra Señora de La Montaña	Cáceres
Spain	Fundación Jiménez Diaz	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Infanta Elena	Madrid
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Univesitario Fundación Hospital de Alcorcón	Madrid
Spain	Hospital Carlos Haya	Malaga
Spain	Hospital Rio Carrion	Palencia
Spain	Hospital Santa Bárbara	Puertollano
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Univeritario Marques de Valdeilla	Santander
Spain	Hospital Universitari Politecnic La Fe	Valencia
Spain	Hospital Santiago Apostol	Vitoria
Spain	Hospital Virgen de La Concha	Zamora

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Subjects With Adverse Drug Reactions	Frequency of patients with adverse reactions, local or systemic	6 weeks	Yes
Secondary	Frequency of Subjects With Systemic Reactions	Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)	6 weeks	Yes
Secondary	Frequency of Subjects With Local Adverse Reaction	Frequency of patients with local adverse reactions	6 weeks	Yes
Secondary	Change in Phleum Pratense Specific IgE-blocking Factor	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)	No
Secondary	Change in Phleum Pratense Specific IgG4		baseline (visit 1) and at 6 weeks (visit 6)	No
Secondary	Change in Immediate Cutaneous Response to Phleum Pratense	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)	No