Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age
Summary
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children
Study Design
Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Conditions
Allergic Rhinitis
Intervention
Olopatadine Hydrochloride Nasal Spray 0.6%, Olopatadine Hydrochloride Nasal Spray Vehicle
Location
Niran Amar, M.D.
Waco
Texas
United States
76712
Status
Completed
Source
Alcon Research
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00794144
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Nasal Sprays
Agents delivered into the nostrils in the form of a mist or spray.
Carbocysteine
A compound formed when iodoacetic acid reacts with sulfhydryl groups in proteins. It has been used as an anti-infective nasal spray with mucolytic and expectorant action.
Nasal Lavage Fluid
Fluid obtained by irrigation or washout of the nasal cavity and NASAL MUCOSA. The resulting fluid is used in cytologic and immunologic assays of the nasal mucosa such as with the NASAL PROVOCATION TEST in the diagnosis of nasal hypersensitivity.
Nasal Cavity
The proximal portion of the respiratory passages on either side of the NASAL SEPTUM. Nasal cavities, extending from the nares to the NASOPHARYNX, are lined with ciliated NASAL MUCOSA.
Nasal Provocation Tests
Application of allergens to the nasal mucosa. Interpretation includes observation of nasal symptoms, rhinoscopy, and rhinomanometry. Nasal provocation tests are used in the diagnosis of nasal hypersensitivity, including RHINITIS, ALLERGIC, SEASONAL.
Clinical Trials
The purpose of this study is to evaluate the onset of action of fluticasone furoate nasal spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic signs...
Safety Study of Olopatadine Nasal Spray
The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to...
The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)
Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
This study is being conducted to obtain additional safety data for PATANASE Nasal Spray
PubMed Articles
BACKGROUND: A proof-of-concept study suggested that combination therapy with commercial azelastine hydrochloride nasal spray and fluticasone propionate nasal spray significantly improved nasal symptom...
Pharmacokinetic evaluation of olopatadine for the treatment of allergic rhinitis and conjunctivitis.
Introduction: Olopatadine hydrochloride is an antihistamine and mast cell stabilizer available in three forms, including oral, intranasal and ocular preparations. Most of the practical applications f...
Abstract Conclusion: Power-assisted turbinectomy is a safe and reliable alternative for patients with nasal blockage if nasal corticosteroid spray therapy is not suitable. Objective: Powered-assisted...
Septoplasty and decongestant improve distribution of nasal spray.
This study prospectively examined the intranasal distribution of nasal spray after nasal septal correction and decongestant administration. A cohort of 20 patients was assessed for the distribution of...
Background: In Japan, oral antihistamines are frequently used as the initial treatment for seasonal allergic rhinitis (SAR), and intranasal steroids are added when nasal symptoms worsen. This study ai...
