Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever: A Pilot Study. (Up-dosing Study)
The purpose of this study is to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing phase, followed by monthly maintenance injections of 100,000 SQ units. Symptom scores and need of rescue medication were recorded by patients during the study period. The size of early and late cutaneous response to allergen challenge was recorded and measured by a physician.
This was a single centre, randomised, double-blind placebo controlled trial of grass pollen injection immunotherapy (Alutard SQ, ALK Abello, Denmark) in adults with severe summer hayfever unresponsive to antihistamines and topical steroids. The main aim was to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing phase, followed by monthly maintenance injections of 100,000 SQ units. Twelve patients received active treatment (mean age 31, 7 male) whilst 6 were given placebo (mean age 37, 2 male). The 24 hour skin response (size of swelling, (mm)) to intradermal allergen challenge (0.1, 1, 10 BU) was determined on alternate weeks during the 8 week up-dosing phase and then monthly up to 6 months and 3 monthly up to 11-13 months following initiation of treatment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01337323 -
Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting
|
N/A | |
| Completed |
NCT00851344 -
Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo
|
Phase 2 | |
| Completed |
NCT00537355 -
An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber
|
Phase 2 | |
| Completed |
NCT00501527 -
Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense
|
Phase 2 | |
| Completed |
NCT00422149 -
Twin SUBLIVAC® Grasses Clinical Efficacy Study
|
Phase 3 | |
| Completed |
NCT00542607 -
Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
|
Phase 4 | |
| Completed |
NCT00605852 -
Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT05960266 -
Immunological Analysis of Lymph Node Tissue After Intralymphatic Immunotherapy: A Prospective Case Control Study
|
Early Phase 1 | |
| Completed |
NCT02256553 -
Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006)
|
Phase 4 | |
| Completed |
NCT00932256 -
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
|
Phase 1 | |
| Completed |
NCT01007721 -
Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season
|
Phase 2 | |
| Completed |
NCT00901914 -
Study of rBet v1 Tablets
|
Phase 2 | |
| Completed |
NCT00384475 -
A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)
|
Phase 3 | |
| Completed |
NCT00839189 -
Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults
|
Phase 1 | |
| Completed |
NCT04687059 -
An Exploratory Study of PQ Grass 27600 SU
|
Phase 2/Phase 3 | |
| Completed |
NCT00889460 -
Safety and Tolerability Study of rBet v1 SLIT Tablets
|
Phase 1 | |
| Completed |
NCT00396149 -
Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1
|
Phase 1 | |
| Completed |
NCT00659594 -
Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in Treatment of Seasonal Allergic Rhinitis (BY9010/M1-406)
|
Phase 3 | |
| Completed |
NCT00127647 -
An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)
|
Phase 3 | |
| Completed |
NCT01480271 -
An Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2245035 in Healthy Volunteers and Allergic Rhinitics.
|
Phase 1 |