Active clinical trials for "Rhinitis, Allergic, Seasonal"

Intranasal corticosteroids are accepted as safe and effective first-line therapy for allergic rhinitis, especially in treatment of persistent symptoms. Budesonide, a non-halogenic glucocorticoid, is widely used in the management of inflammatory mucosal diseases like chronic obstructive pulmonary disease, asthma and allergic rhinitis. It is a highly fat-soluble substance with low water solubility and is presented as dispersion in marketed nasal sprays, like Rhinocort aqua 64. The maximum therapeutic efficacy of Rhinocort aqua is obtained after an application period of 7 to 14 days. In Budesolv, the solubility of budesonide is considerably increased suggesting that the same therapeutic efficacy can be reached with a lower dose. Better bioavailability of the dissolved drug promise an earlier onset of therapeutic efficacy. The current trial is undertaken to demonstrate these two effects. Subjects suffering from grass pollen allergic rhinitis will be challenged with grass pollen in a challenge chamber. Allergic subjects will be treated with two actuations (50 μl) of respective study treatment into each nostril once daily for 8 days. The total daily budesonide dose will be 40 μg per subject for Budesolv 10 and 256 μg per subject for Rhinocort® aqua 64. The primary objective of the study is to show non-inferiority of Budesolv 10 to Rhinocort® aqua 64. On day 8 grass pollen allergic patients will be challenged with grass pollen over a period of 6 hours and subjective nasal symptoms (congestion, sneezing, itching, rhinorrhea) as well as objective symptoms (nasal airflow, nasal secretion) will be assessed every 15 minutes. The second objective of the trial is to demonstrate an early on-set of therapeutic efficacy of Budesolv 10 compared to Rhinocort aqua. On day 1, grass pollen allergic patients will be challenged with grass pollen allergen in the challenge chamber over a period of 6 hours. After 1 hour 45 minutes, patients will receive their first dosage of the respective nasal spray treatment. During the 6 hour grass pollen challenge, subjective and objective endpoints will be measured every 15 minutes. To eliminate an individual bias based on expectations, the effect and onset of action is also compared to the effects of a suitable placebo. The same set of study participants will receive all three interventions in three consecutive treatment periods.

The objective of this study is to assess the effect of 'Eucerin AtopiControl LOTION' and 'Eucerin AtopiControl facial cream' on dermal symptoms in patients with Atopic Dermatitis (AD) after two 4 h challenges with grass pollen on two consecutive days. In addition, this clinical study with exposure of Dactyls glomerate-sensitized Patients with AD shall be used to compare the skin response with AD Patients not-sensitized to Dactylis glomerata to understand the specificity of the grass pollen exposure.

Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

The objective of this clinical trial was to assess the efficacy and safety of cetirizine HCl syrup vs. loratadine syrup vs. placebo syrup in the treatment of SAR in children 6 to 11 years old.

There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. The current therapeutic dose regimen for Grass MATA MPL is a course of four injections of 300, 800, 2000 and 2000 SU (Standardized Units), administered at weekly intervals (cumulative dose 5100 SU). Two new cumulative doses of the Grass MATA MPL 10200 SU and 18200 SU are being developed to compare with the current dose. The study is designed to explore the benefit/risk of increasing the cumulative allergen dose of the Grass MATA MPL immunotherapy comparing these doses with the current dose of Grass MATA MPL, Grass MATA (without MPL) and placebo.

The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.

The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT, grass pollen tablets under the tongue) has long term effects in severe hay fever.

The purpose of this study was to evaluate the effects of Ischia thermal waters nasal irrigation on allergic rhinitis and airway inflammation during the period of natural exposure to parietaria pollen in children with allergic rhinitis and intermittent asthma.

Ectoin acts on membranes by forming an Ectoin-Hydro-Complex therewith providing a protection against external agents like aeroallergens. The effects of Ectoin containing nasal spray and eye drops have already been demonstrated in several studies with adult Seasonal Allergic Rhinitis (SAR) patients and it was shown that they can effectively reduce symptoms of allergic rhinitis without resulting in any significant adverse events. The aim of this clinical investigation is to demonstrate the safety, tolerability and efficacy of Ectoin Nasal Spray and Ectoin Eye Drops in pediatric and adolescent SAR patients. It is assumed that Ectoin containing products show an excellent safety profile and very good tolerability together with a potent efficacy in the treatment of SAR.

Allergic diseases represent a major health issue worldwide and epidemiological studies in Melbourne, Australia, have reported a high prevalence of rhinitis (hayfever) and atopy (genetic tendency to make allergy antibody) in Asian and Caucasian subjects. Mainstay treatment of allergic rhinitis is allergen avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the advantages of specific treatment with long lasting efficacy, and can modify the course of disease. However, use of this treatment is restricted by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes of allergen administration than the current conventional subcutaneous route (SCIT) have been investigated including the sublingual route (SLIT) and recently sublingual tablets for pollen allergy immunotherapy became available. The tablets are safe and easy to use and contain pollen extracts from 5 of the most common allergy-causing European grasses but include ryegrass (Lolium perenne), the major seasonal pollen for allergy in Melbourne and south-eastern Australia. The immunological mechanisms of sublingual immunotherapy are not fully understood. The investigators propose conducting a longitudinal open label study to investigate the immunological changes that occur with the 5 grass pollen sublingual immunotherapy tablet (Oralair®) in a cohort of Chinese and non-Chinese background subjects. The investigators will investigate the induction of relevant T cell regulatory immune mechanisms and changes in serum allergen-specific immunoglobulin (Ig) E and IgG4. Immunoregulatory cytokine synthesis and T cell phenotype (Bio-plex and flow cytometry) will be examined. This project will provide important fundamental knowledge on which to inform decisions for the greater application of this treatment for subjects with moderate and severe allergic rhinitis.