Phase 3
Completed N=196
An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
Allergic Rhinoconjunctivitis
Source: ClinicalTrials.gov NCT01454531 ↗
Enrolled (actual)
196
Serious AEs
1.6%
Results posted
Mar 2015
Primary outcomePrimary: Frequency of Subjects With Adverse Drug Reactions — 133 participants
Summary
The purpose of this study is to assess the tolerability of AVANZ.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Subjects With Adverse Drug Reactions |
133 | — |
| SECONDARY Frequency of Subjects With Systemic Reactions |
66 | — |
| SECONDARY Frequency of Subjects With Local Adverse Reaction |
109 | — |
| SECONDARY Change in Phleum Pratense Specific IgE-blocking Factor |
-0.13; 0.12 | <0.001 sig |
| SECONDARY Change in Phleum Pratense Specific IgG4 |
0.44; 2.26 | <0.001 sig |
| SECONDARY Change in Immediate Cutaneous Response to Phleum Pratense |
1.79 | <0.01 sig |
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
Data sourced from ClinicalTrials.gov (NCT01454531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.