Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
Twin SUBLIVAC® Grasses Clinical Efficacy Study
To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.
Indication under study: IgE mediated allergic disorders triggered by grass pollen.
Number of centres: approximately 50.
Study period planned: Q2-2006 until Q3-2008 Analysis after one exposed season (2007); based
on the outcome the study will be stopped or continued for another season.
Subject selection criteria: Seasonal rhinitis and/or rhinoconjunctivitis with or without
mild asthma (FEV1 > 70%) related to grass pollen, age 12 years or older.
Dosage schedule: Start with two drops daily of SUBLIVAC® and increase by two drops daily,
until the maintenance dose of 10 drops SUBLIVAC® GrassesSUBLIVAC® Grasses is reached.
Route of administration: Sublingual application (drops are to be held underneath the tongue
for 2-3 minutes and then will be swallowed).
Duration of treatment: 6 to 12 months blinded per subject . Efficacy parameters
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: 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 |
NCT00501527 -
Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense
|
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 |
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 |
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 |
NCT00932256 -
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
|
Phase 1 | |
| 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 |
NCT00135629 -
Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever
|
Phase 3 | |
| 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 |