Trials / Completed
CompletedNCT01489033
Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Phleum Pratense.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Roxall Medicina España S.A · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic disease the aim of this study was to assess safety and tolerability of three different subcutaneous immunotherapy dose escalations in patients allergic to the pollen of Phleum pratense.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Subcutaneous immunotherapy with Phleum pratense pollen extract | Increasing doses up to a maximum dose of 500 TSU |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2010-04-01
- Completion
- 2010-05-01
- First posted
- 2011-12-09
- Last updated
- 2017-05-01
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01489033. Inclusion in this directory is not an endorsement.