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NCT00261287 Clinical Trial

Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)

Perennial Allergic Rhinitis Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Tolerability of Ciclesonide (200 mcg Once Daily), Applied as a Nasal Spray for Twelve Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00261287
Other study ID # BY9010/M1-416
Secondary ID
Status Completed
Phase Phase 3
First received December 2, 2005
Last updated November 29, 2016
Start date November 2005
Est. completion date June 2006

Study information
Verified date October 2016
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 5 Years
Eligibility Main Inclusion Criteria:

- General good health, other than perennial allergic rhinitis

- History and diagnosis of perennial allergic rhinitis by skin prick test

- History of perennial allergic rhinitis for a minimum of 90 days immediately before the screening visit

Main Exclusion Criteria:

- Participation in any investigational drug trial within the 30 days before the screening visit

- Use of any disallowed concomitant medications within the prescribed withdrawal periods before the screening visit

- A known hypersensitivity to any corticosteroid

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ciclesonide

Locations
Country Name City State
United States Altana Pharma/Nycomed Long Beach California
United States Altana Pharma/Nycomed Normal Illinois
United States Altana Pharma/Nycomed San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of ciclesonide nasal spray
See also
  Status Clinical Trial Phase
Completed NCT01654536 - A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR) Phase 4
Completed NCT01539304 - Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis Phase 3
Completed NCT01221285 - Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium Phase 1
Terminated NCT00491374 - Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED) Phase 4
Completed NCT00783224 - A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512) Phase 3
Completed NCT04324918 - Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis Phase 3
Completed NCT02532179 - Subcutaneous Immunotherapy for Mouse in Adults Phase 1/Phase 2
Completed NCT01451541 - A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR). Phase 3
Enrolling by invitation NCT01062139 - Cosalin® Monotherapy Versus Cosalin® and Xarlin® Combination Therapy Phase 4
Completed NCT00405899 - Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections N/A
Completed NCT01549340 - Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022) N/A
Completed NCT01018862 - A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis Phase 3
Completed NCT00789555 - Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis Phase 4
Completed NCT00974571 - Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246) Phase 3
Completed NCT04654702 - Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.
Completed NCT05122143 - Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers N/A
Completed NCT01380327 - Biomarkers of Cockroach Sublingual Immunotherapy 2 Phase 1/Phase 2
Completed NCT01116778 - the Efficacy and Safety of Probiotics eN-Lac® Capsules of Children With Perennial Allergic Rhinitis Phase 3
Completed NCT00359216 - The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726) Phase 4
Completed NCT00163514 - Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403) Phase 3

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