Trials / Completed
CompletedNCT01085526
Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Allergic Rhinitis
Changes in Specific Immunoglobulin and Blood Basophil Activity During Subcutaneous Immunotherapy in Patients With Allergic Rhinitis Due to Grass Pollen Allergy - a Prospective Randomized Controlled Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Aarhus University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
The trial is randomized prospective study to examine the effects of subcutaneous immunotherapy on the adaptive immune system. The trial includes 30 participants randomized to treatment or control group. The effect measures are changes in the basophil activity and biology as well as changes in plasma cells during and after treatment. Clinical outcome is assessed by QoL questionnaires and clinical testing. Hypotheses: * changes in plasma cells correlate to changes in immunoglobulins and effector cell responses * the reduction of inflammation due to SCIT has influence on the effector cell responses * changes in paraclinical measurements can be related to clinical findings
Detailed description
The investigators are recruiting 30 participants, which are randomized to receive SCIT (24) or no treatment (6) The following will be measured * the development of immunoglobulin response * plasma cells under updosing phase * changes in basophil activity under updosing and maintenance treatment * subtyping of allergic sensitization * clinical outcome and quality of life * changes in mast cells in the nasal mucosa * changes in the cell biology of the basophils
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Alutard phleum pratense subcutaneous immunotherapy | standard regimen of SCIT |
| DRUG | Alutard phl prat |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2014-07-01
- Completion
- 2014-09-01
- First posted
- 2010-03-12
- Last updated
- 2015-02-18
Source: ClinicalTrials.gov record NCT01085526. Inclusion in this directory is not an endorsement.