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Rhinocort™(budesonide) Clinical Trial report summaries

Rhinocort™ (budesonide) is an anti-inflammatory glucocorticosteroid for the once-daily treatment of non-infectious rhinitis, and for treatment and prevention of nasal polyposis. Non-infectious rhinitis includes seasonal allergic rhinitis (hay fever), perennial allergic rhinitis (e.g. house dust mite allergy), and perennial non-allergic rhinitis.

The following nasal formulations of Rhinocort are available: RhinocortAqua (a water-based suspension in a pump spray), RhinocortTurbuhaler (nasal inhalation powder), and Rhinocort pMDI (pressurised metered dose inhaler). 

Please consult the prescribing information for the country concerned for guidance on the approved use of Rhinocort™ (budesonide).

Study Number Completed Clinical Trial Report Summaries

D5360C00005

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Phase IIIB Study to Assess the Efficacy, Safety and Product Attributes of RHINOCORT AQUA® (budesonide) Versus Placebo and Fluticasone Propionate as an Active Comparator in Patients 12 Years of Age and Older with Seasonal Allergic Rhinitis

SD-005-CR-0170

An Investigation of the use of the Rhinocort ® Aqua in the Treatment of Chronic Rhinosinusitis

SD-005-0341

A study assessing efficacy of budesonide aqueous nasal spray (Rhinocort® Aqua) in children with perennial allergic rhinitis

SD-005-0689

A comparison of the nasal mucosal tissue concentrations of budesonide, budesonide oleate, budesonide palmitate and mometasone furoate in seasonal allergic rhinitis patients out of season

SD-005-0694

Bioequivalence study in healthy volunteers comparing the pharmacokinetic profiles of budesonide delivered from the Rhinocort Aqua ® winged applicator (current and pH-modified formulation) and from the Rhinocort Aqua ® new nasal device (pH-modified formulation)

SD-005-0697

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of RHINOCORT AQUA (budesonide) Nasal Spray on the Hypothalamic-Pituitary-Adrenal (HPA) Axis Function in Pediatric Patients with Allergic Rhinitis

SD-005-0698

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Functionality of a New Nasal Device with Reformulated RHINOCORT AQUA® (budesonide) Versus the Current Product and Versus Placebo in Patients with Seasonal Allergic Rhinitis (SAR)

SD-005-0703 (D5360C00703)

 A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Phase II Study to Assess the Efficacy and Safety of RHINOCORT AQUA® (budesonide) Nasal Spray, 16 mg, 32 mg and 64 mg per day versus Placebo in Pediatric Subjects, Ages 2-5 Years Old with Allergic Rhinitis.

SD-005-0705

 A Double Blind, Double Dummy, Randomized, Placebo controlled Cross Over Exploratory Study to Assess the Efficacy of RHINOCORT AQUA® (budesonide) Nasal Spray in Combination with Intranasal OXIS TURBUHALER® in an Allergic Rhinitis Challenge Model – Test of Concept

SD-005-0414

 A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Long-term Treatment with RHINOCORT AQUAâ (budesonide) Nasal Spray in Children with Perennial Allergic Rhinitis.

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