Clinical trial NCT01454531: An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
Official title: An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergic Rhinoconjunctivitis
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2011-10-19
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Uncontrolled severe asthma

Primary outcomes:
measure: Frequency of Subjects With Adverse Drug Reactions
timeFrame: 6 weeks
Secondary outcomes:
measure: Frequency of Subjects With Systemic Reactions
timeFrame: 6 weeks
measure: Frequency of Subjects With Local Adverse Reaction
timeFrame: 6 weeks
measure: Change in Phleum Pratense Specific IgE-blocking Factor
timeFrame: baseline (visit 1) and at 6 weeks (visit 6)
measure: Change in Phleum Pratense Specific IgG4
timeFrame: baseline (visit 1) and at 6 weeks (visit 6)
measure: Change in Immediate Cutaneous Response to Phleum Pratense
timeFrame: baseline (visit 1) and at 6 weeks (visit 6)
Other outcomes:
Locations:
city: Avila
country: Spain
facility: Hospital Nuestra Señora de Sonsoles
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Burgos
country: Spain
facility: Complejo Hospitalario de Burgos
city: Cáceres
country: Spain
facility: Hospital Nuestra Señora de La Montaña
city: Cáceres
country: Spain
facility: H. Campo Arañuelo
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Fundación Jiménez Diaz
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Infanta Elena
city: Madrid
country: Spain
facility: Hospital Univesitario Fundación Hospital de Alcorcón
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Palencia
country: Spain
facility: Hospital Rio Carrion
city: Puertollano
country: Spain
facility: Hospital Santa Bárbara
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Univeritario Marques de Valdeilla
city: Valencia
country: Spain
facility: Hospital Universitari Politecnic La Fe
city: Vitoria
country: Spain
facility: Hospital Santiago Apostol
city: Zamora
country: Spain
facility: Hospital Virgen de La Concha
Study officials:
affiliation: FUNDACIÓN JIMÉNEZ DIAZ
name: JOAQUIN SASTRE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: