Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide,...
RhinitisAllergic2 moreThe 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.
Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial...
RhinitisAllergic1 moreKetotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.
Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine...
Seasonal Allergic RhinitisTo compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized objective measure of attention, accuracy and reaction time in healthy naval flight personnel. Specifically, the primary objective is to compare the AVT overall (average of the 18 blocks) mean change from baseline in total number of errors (commission errors + omission errors) between fexofenadine HCl and cetirizine 10 mg. Safety of these single-dose treatments also will be assessed.
The Effect of Nasal Carbon Dioxide (CO2) on Nasal Congestion in Subjects With Perennial Allergic...
Perennial Allergic RhinitisThe purpose of this study is to evaluate the effect of nasal CO2 on nasal congestion and other symptoms related to Perennial Allergic Rhinitis.
To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis
Allergic RhinitisAllergic rhinitis is a common condition characterize by inflammation of the upper airways. Third generation antihistamines have been demonstrated effective in the treatment of this condition. Allergen challenge can be use to assess the effects of drugs in allergic rhinitis, adenosine monophosphate may also be used as a means to investigate these effects but as yet its effects have yet to be compared to allergen challenge. We intend to compare the effects of levocetirizine at a single dose of 5mg on allergen and AMP challenge compared to placebo in a double blind cross-over study. The study will include 20 patients with allergic rhinitis. Each patient will have allergen and AMP challenge on placebo and active treatment. The primary outcome variable will be the change in concentration of AMP/Allergen required to produce a 20% drop in nasal flow as manifest by peak nasal inspiratory flow. A 1 doubling dose change in concentration of challenge medium to cause a 20% drop in nasal flow will be deemed significant. We will also measure time to recovery after both challenges. AMP challenge is a safe alternative to allergen challenge and does not have the risk of anaphylaxis.
A Phase II Study Evaluating Intranasal GSK256066 and Fluticasone Propionate in Subjects With Seasonal...
RhinitisAllergic1 moreThis is an 8 day, randomised, double blind, 3-way crossover trial of repeat doses of intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Approximately 60 subjects will be selected for enrolment with the intention of acquiring at least 48 evaluable subjects. Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.
Single and Repeat Dose First Time in Human Study for an Intranasal H1/H3 Dual Antagonist in Healthy...
RhinitisAllergic1 moreThis is a double-blind, placebo-controlled, randomized single dose escalation study and a double-blind, placebo-controlled, randomised parallel group 14-days once daily repeat dose study to investigate safety, tolerability and pharmacokinetics of an intranasal H1/H3 dual antagonist compound in healthy male subjects.
New Nasal Applicator / New Formulation - User Study
Seasonal Allergic RhinitisThe purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental...
RhinitisAllergic1 moreThis will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study. After passing the initial Screening Visit, subjects will be in the environmental exposure chamber(EEC), a room with a controlled amount of ragweed pollen, for 4 hours each day on 4 consecutive days. At the last visit, subjects who have achieved a minimum Total Nasal Symptom Score (TNSS) will be randomized to receive either TOLAMBA or placebo treatments. Subjects will receive 6 weekly subcutaneous (under the skin) injections of the study drug. About three weeks after the last injection, subjects will be asked to be in the EEC for 2 consecutive days (Visits 11 and 12, Days 60 and 61). Approximately 3 weeks after Visit 12 (Day 61), the subjects will again be in the EEC for 4 consecutive days (Visits 13-16, Days 82-85). During all EEC visits, the subjects will be exposed to ragweed pollen at an average concentration of 3500 ± 500 pollen grains per cubic meter. Each EEC visit will last 4 hours. During each EEC visit, patients will be asked to record symptom scores for nasal and non-nasal symptoms at scheduled time points. The total duration of a subject's participation in this study is expected to be a minimum of 85 days.
Singulair(R) In Asthma And Allergic Rhinitis (0476-383)
AsthmaEffectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.