CLINICAL TRIALS PROFILE FOR RHINOCORT

505(b)(2) Clinical Trials for Rhinocort

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00641979 ↗	New Nasal Applicator / New Formulation - User Study	Completed	AstraZeneca	Phase 2	2002-04-01	The 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).
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Medstar Health Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Patient-Centered Outcomes Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Penn State College of Medicine	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of California, Los Angeles	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of Washington	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.

All Clinical Trials for Rhinocort

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00560586 ↗	Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome	Completed	University of Louisville	Phase 4	2004-04-01	-Intranasal budesonide therapy may lead to improved symptoms and sleep study findings in children with mild obstructive sleep apnea with and without allergic rhinitis that would not be treated with T&A. The aim of the study is to conduct a randomized double blind cross-over trial comparing the effect of once a day intranasal budesonide therapy vs. placebo in children with mild sleep apnea that would not be candidates for T&A.
NCT00641212 ↗	Children, Perennial Allergic Rhinitis (PAR), l-t Growth	Completed	AstraZeneca	Phase 4	2000-01-01	The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on growth in children with perennial allergic rhinitis over 12 months.
NCT00641680 ↗	Rhinocort Aqua Versus Placebo and Fluticasone Propionate	Completed	AstraZeneca	Phase 3	2003-04-01	The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
NCT00641693 ↗	Assess the Efficacy and Safety of Rhinocort Aqua	Completed	AstraZeneca	Phase 2	2004-04-01	The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.
NCT00641979 ↗	New Nasal Applicator / New Formulation - User Study	Completed	AstraZeneca	Phase 2	2002-04-01	The 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).
NCT00826163 ↗	Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients	Completed	National Science and Technology Development Agency, Thailand	Phase 3	2009-01-01	We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response

Clinical Trial Conditions for Rhinocort

Condition Name

Condition Name for Rhinocort
Intervention	Trials
Seasonal Allergic Rhinitis	4
Allergic Rhinitis	2
Acute Sinusitis	1
Allergic Conjunctivitis	1

Condition MeSH

Condition MeSH for Rhinocort
Intervention	Trials
Rhinitis	9
Rhinitis, Allergic	7
Rhinitis, Allergic, Seasonal	5
Conjunctivitis, Allergic	1

Clinical Trial Locations for Rhinocort

Trials by Country

Trials by Country for Rhinocort
Location	Trials
United States	9
Canada	3
China	3
Thailand	1
Austria	1

Trials by US State

Trials by US State for Rhinocort
Location	Trials
Wisconsin	1
Washington	1
Virginia	1
Pennsylvania	1
Maryland	1

Clinical Trial Progress for Rhinocort

Clinical Trial Phase

Clinical Trial Phase for Rhinocort
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	3
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Rhinocort
Clinical Trial Phase	Trials
Completed	10
Recruiting	1
Withdrawn	1

Clinical Trial Sponsors for Rhinocort

Sponsor Name

Sponsor Name for Rhinocort
Sponsor	Trials
AstraZeneca	4
Ligand Pharmaceuticals	2
Medstar Health Research Institute	1

Sponsor Type

Sponsor Type for Rhinocort
Sponsor	Trials
Other	13
Industry	10
NIH	1