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A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)
NCT01458275 · View on ClinicalTrials.gov ↗
Study Summary
This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ciclesonide nasal aerosol 37 mcg
- DRUG ciclesonide nasal aerosol 74 mcg
Study Locations (20)
California
- San Jose Multispecialty Medical Group, Inc — Baldwin Park
- WCCT Global, LLC — Costa Mesa
- Premier Health Research Center — Downey
- Allergy, Asthma, Brochitis and Immunology Assoc Medical Group — Fountain Valley
- Pediatric Care Medical Group, Inc. — Huntington Beach
- Pediatric Care Medical Group — Huntington Beach
- Allergy and Asthma Associates of Southern California — Mission Viejo
- CHOC, PSF, AMC, Division of Allergy, Asthma, and Immunology — Orange
- Center for Clinical Trials, LLC — Paramount
- Peninsula Research Associates — Rolling Hills Estates
- Capital Allergy & Respiratory Disease Center — Sacramento
- Allergy Associates Medical Group — San Diego
- Allergy & Asthma Medical Group and Research Center, APC — San Diego
- Bensch Research Associates — Stockton
Colorado
- Asthma & Allergy Associates, PC — Colorado Springs
- Storms Clinical Research Institute — Colorado Springs
- Colorado Allergy and Asthma Centers, PC — Denver
Georgia
- Northeast Georgia Research Center — Gainesville
- DataQuest Medical Research, LLC — Lawerenceville
Arkansas
- Arkansas Pediatric Clinic — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 847 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01458275
The ClinicalTrials.gov registry entry for NCT01458275 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 847 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Seasonal Allergic Rhinitis appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01458275 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Colorado, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01458275 about?
NCT01458275 is a clinical study titled "A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)". This is a 2-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years-old diagnosed with SAR.
What is the current status of trial NCT01458275?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 847 participants. The study started on 2011-11. Estimated completion is 2013-03.
What conditions does trial NCT01458275 study?
This clinical trial studies the following conditions: Seasonal Allergic Rhinitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01458275?
The interventions under investigation include: Placebo (DRUG), Ciclesonide nasal aerosol 37 mcg (DRUG), ciclesonide nasal aerosol 74 mcg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01458275?
This trial is sponsored by Sumitomo Pharma America, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01458275 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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