An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
- Conditions
- Allergic Rhinoconjunctivitis
- Interventions
- Drug: AVANZ Phleum pratense
- Registration Number
- NCT01454531
- Lead Sponsor
- ALK-Abelló A/S
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 199
- History of grass pollen rhinoconjunctivitis
- Positive SPT to Phleum pratense
- Positive specific IgE against Phleum pratense
- Uncontrolled severe asthma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AVANZ Phleum pratense AVANZ Phleum pratense AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
- Primary Outcome Measures
Name Time Method Frequency of Subjects With Adverse Drug Reactions 6 weeks Frequency of patients with adverse reactions, local or systemic
- Secondary Outcome Measures
Name Time Method Change in Phleum Pratense Specific IgE-blocking Factor 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 measureFrequency of Subjects With Systemic Reactions 6 weeks 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 6 weeks Frequency of patients with local adverse reactions
Change in Phleum Pratense Specific IgG4 baseline (visit 1) and at 6 weeks (visit 6) Change in Immediate Cutaneous Response to Phleum Pratense 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
Trial Locations
- Locations (20)
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital Universitario Infanta Cristina
🇪🇸Badajoz, Spain
Hospital Nuestra Señora de Sonsoles
🇪🇸Avila, Spain
Complejo Hospitalario de Burgos
🇪🇸Burgos, Spain
Hospital Nuestra Señora de La Montaña
🇪🇸Cáceres, Spain
H. Campo Arañuelo
🇪🇸Cáceres, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Fundación Jiménez Diaz
🇪🇸Madrid, Spain
Hospital Infanta Leonor
🇪🇸Madrid, Spain
Hospital Infanta Elena
🇪🇸Madrid, Spain
Hospital Univesitario Fundación Hospital de Alcorcón
🇪🇸Madrid, Spain
Hospital Carlos Haya
🇪🇸Malaga, Spain
Hospital Rio Carrion
🇪🇸Palencia, Spain
Hospital Santiago Apostol
🇪🇸Vitoria, 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 Virgen de La Concha
🇪🇸Zamora, Spain