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Hay Fever clinical trials

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NCT ID: NCT01137357 Completed - Hay Fever Clinical Trials

Probiotics for Reduction Of Markers In Subjects With Allergy

PROMISA
Start date: November 2008
Phase: N/A
Study type: Interventional

In vitro studies reveal immunomodulatory effects of probiotic bacteria that are strain-dependent. Differential immunomodulatory in vitro capacities can not be extrapolated directly to in vivo efficacy. Thus, in vitro screening should be followed by comparative analysis of the selected immunomodulatory probiotic strains in an in vivo setting. Birch pollen allergy is one of the most common forms of respiratory allergy in European countries, and recognized by a Th2-skewed immune system. Five Lactobacillus strains will be evaluated for their immunomodulatory properties in birch pollen sensitive subjects outside the hay fever season. A double-blind placebo-controlled parallel study will be performed in which subjects with a proven birch pollen allergy will consume one of 5 different probiotic yoghurts containing 4 L. plantarum strains and 1 L. casei strain or a placebo yoghurt. Blood samples are collected at the start and after 4 weeks. Immune parameters are determined in serum and peripheral blood mononuclear cell cultures (hPBMC) derived from these subjects.

NCT ID: NCT01024608 Completed - Clinical trials for Seasonal Allergic Rhinitis

Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

Start date: December 31, 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.

NCT ID: NCT00659841 Completed - Clinical trials for Rhinitis, Allergic, Seasonal

To Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-401)

Start date: December 2003
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the efficacy of ciclesonide applied as a nasal spray once daily in patients with SAR. The secondary objectives are to evaluate Quality-of-Life and safety.

NCT ID: NCT00659594 Completed - Clinical trials for Rhinitis, Allergic, Seasonal

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)

Start date: November 2004
Phase: Phase 3
Study type: Interventional

The primary objective of this placebo-controlled EEC study is to determine the time to onset of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR.

NCT ID: NCT00659503 Completed - Clinical trials for Rhinitis, Allergic, Seasonal

Study Using the Environmental Exposure Unit (EEU) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-407)

Start date: February 2005
Phase: Phase 3
Study type: Interventional

The primary objective of this placebo-controlled EEU study is to determine the time to onset of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR.

NCT ID: NCT00658918 Completed - Clinical trials for Rhinitis, Allergic, Perennial

To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405)

Start date: September 2004
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the safety of three dose levels of ciclesonide administered as an intranasal spray for six weeks, 200µg, 100µg or 25µg, once daily, in pediatric patients (ages 2-5 years) with PAR. The secondary objective is to measure serum concentrations of ciclesonide and its active metabolite under steady state conditions at three time points corresponding to the presumed peak and trough exposure after six weeks of administration. In addition, reflective (24-hour) total nasal symptom score (TNSS) over the six weeks of treatment at various timepoints and a physician assessment of nasal symptoms at endpoint were summarized.

NCT ID: NCT00574379 Completed - Clinical trials for Seasonal Allergic Rhinitis

Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR

Start date: December 2007
Phase: Phase 2
Study type: Interventional

Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.

NCT ID: NCT00574210 Completed - Clinical trials for Seasonal Allergic Rhinitis

PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months prior to randomization.

NCT ID: NCT00384475 Completed - Clinical trials for Rhinitis, Allergic, Seasonal

A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)

Start date: October 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of seasonal allergic rhinitis caused by pollen. Ciclesonide will be administered once during the exposure to ragweed pollen in a controlled environment. The study duration consists of a baseline period (up to 5 days) and a treatment period (1 day). The study will provide further data on safety and tolerability of ciclesonide.

NCT ID: NCT00305487 Completed - Clinical trials for Seasonal Allergic Rhinitis

Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)

Start date: March 2006
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).