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Rhinitis, Allergic, Seasonal clinical trials

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NCT ID: NCT01628484 Completed - Clinical trials for Birch Pollen Allergy

Physiological Study to Determine the Allergic Skin Activity After Different Skin Preparation

Start date: July 2012
Phase: Phase 1
Study type: Interventional

The objectives of this monocentric investigator initiated exploratory clinical trial is to optimize allergen delivery across the epidermal barrier. The cornified outer epidermal layers represent the main barrier towards entry into the viable epidermal layers. In the latter we aim to target the allergen for uptake by professional antigen presenting cells, called Langerhans cells. At the same time as little allergen as possible should be delivered to the dermis. The latter contains a high density of sensitized mast cells eliciting local reactions and also a high density of blood vessels which could lead to systemic distribution of allergen and therefore to systemic allergic reactions. In birch pollen allergic individuals we will compare different methods of preparing the skin before application of the allergen. We will subsequently apply titrated allergen doses to the prepared skin areas to determine at which dose we start observing mast cell degranulation manifesting as hives. This will allow for determination of the maximal tolerated allergen dose for each skin preparation method. The skin preparation methods compared will be: - Single pricking with prick lancet (Entaco LTD., Redditch, Worcestershire, UK, distributed by Stallergenes®). - Tape stripping with conventional adhesive Tape (Tesa-film®). - Microchanneling with Micro Needle Patch (Micro Skin System, 3M®). The methods are strongly connected to routine diagnostics of allergies with low risk associated. The clinical trial protocol has been submitted to the local Ethics Committee. This comparison of skin preparation methods and the determination of the maximal tolerated allergen dose will help us to further improve epicutaneous allergen immunotherapy, which has the potential to make allergen specific immunotherapy not only considerably shorter and safer, but also more convenient for patients. Skin preparation by microneedle patches is significantly less painful than conventional injection and can be self administered. This should help improve the acceptance of allergen specific immunotherapy, as well as treatment compliance.

NCT ID: NCT01578278 Completed - Clinical trials for Seasonal Allergic Rhinitis

Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

Start date: December 2011
Phase: Phase 2
Study type: Interventional

This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.

NCT ID: NCT01555736 Completed - Clinical trials for Seasonal Allergic Rhinitis

Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

Start date: January 2003
Phase: Phase 4
Study type: Interventional

Specific immunotherapy, which involves the administration of allergic extracts to patients with symptoms of allergic disorder, is the leading therapeutical tool of modern allergology. According to the latest studies immunotherapy not only reduces symptoms' severity but also may modify the course of allergic disease by reducing the risk of new sensitisations and development of more advanced stages of the disease.It has been hypothesized basing on clinical observation that perennial immunotherapy is more effective and safer in comparison to preseasonal immunotherapy. The aim of the study was to compare the effect of perennial and preseasonal immunotherapy on rhinoconjunctivitis symptoms and safety of both treatments.

NCT ID: NCT01549340 Completed - Clinical trials for Seasonal Allergic Rhinitis

Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022)

Start date: November 2011
Phase: N/A
Study type: Observational

The purpose of this study is to determine the proportion of participants that initiate allergen immunotherapy (AIT) upon the recommendation of their physician and the proportion of participants that persist with their AIT throughout the recommended course.

NCT ID: NCT01538979 Completed - Clinical trials for Grass Pollen Allergy

Phase II Study of Grass Pollen Allergy Vaccine BM32

Start date: March 2012
Phase: Phase 2
Study type: Interventional

The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects. It will test the hypothesis that either of two doses of BM32 will lead to a sustained relief off allergy symptoms over a two year study period.

NCT ID: NCT01523236 Completed - Clinical trials for Seasonal Allergic Rhinitis

Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation

Start date: December 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to evaluate the clinical equivalence of the test formulation of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) to the marketed formulation Nasonex® (mometasone furoate monohydrate) nasal spray, 50 mcg/actuation (Schering) in patients with seasonal allergic rhinitis. In addition, the efficacy of both the test and reference nasal sprays will be compared to a placebo nasal spray and safety will be compared.

NCT ID: NCT01506375 Completed - Hay Fever Clinical Trials

Safety of gpASIT+TM Subcutaneously Administered to Hay Fever Patients With or Without Immunoregulating Adjuvant

Start date: November 2011
Phase: Phase 2
Study type: Interventional

The aim of the study is to compare the safety, clinical tolerability, immunogenicity and efficacy of gpASIT+TM (grass pollen peptides) alone and combined with an immunoregulating adjuvant, in a short course administration (5 injections over 4 weeks).

NCT ID: NCT01500642 Completed - Pollen Allergy Clinical Trials

Comparison of the Efficacy and the Safety of Different Schedules of Administration of Sub-lingual Immunotherapy

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The dose and the mode of administration of sublingual therapy remain open questions to determine the efficacy and safety of this desensitization therapy, the main purpose of this study is to evaluate if different routes of administration (oral-vestibular vs. sublingual) and a maximum dose of allergen administered are able to determine a different effect or a different incidence of side effects of the therapy in a group of patients with rhinoconjunctivitis and/or asthma due to ragweed

NCT ID: NCT01500629 Completed - Clinical trials for Rhinitis, Allergic, Seasonal

Study of a Topical Nasal Spray to Ease the Symptoms of Hayfever

Start date: January 2012
Phase: Phase 0
Study type: Interventional

The purpose of this study is to see if a new nasal spray can reduce the signs and symptoms of allergic rhinitis (hayfever). Subjects' participation in the study will last approximately 4 to 6 weeks, and each of three study visits during that time will last a few hours. Subjects will be required to have several tests done including allergy and breathing tests. They will be exposed to the item they are allergic to and will have small paper discs put in their noses. Subjects will also have the inside of their noses examined and will be asked questions about the level of their allergy symptoms.

NCT ID: NCT01484119 Completed - Clinical trials for Seasonal Allergic Rhinitis

Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis

SAR
Start date: December 2011
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen.