Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01654536 · ClinicalTrials.gov registry record · Phase 4

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)

A Phase 4 study of Perennial Allergic Rhinitis, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 4
Development phase
737
Enrollment target
20
Study locations

NCT01654536 is a Phase 4 study of Perennial Allergic Rhinitis that has completed, run by Sumitomo Pharma America. The registered enrollment target is 737 participants, above the 427-participant average among 4 other Perennial Allergic Rhinitis trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 12 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01654536, a Phase 4 study of Perennial Allergic Rhinitis, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 4
Development phase
737 participants
Enrollment target
20
Study locations

Study Summary

This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR.

Interventions

  • DRUG ciclesonide nasal aerosol
  • DRUG ciclesonide nasal spray

Study Locations (20)

California

  • Allergy & Asthma Associates of Southern California - Mission Viejo
  • CHOC PSF AMC - Division of Allergy, Asthma and Immunology - Orange
  • Allergy Associates Medical Group Inc. - San Diego
  • Bensch Research Associates - Stockton

New Jersey

  • Ocean Allergy & Respiratory Research Center - Brick
  • Atlantic Research Center, LLC - Ocean City
  • Princeton Center for Clinical Research - Skillman

Georgia

  • DataQuest Medical Research LLC - Lawerenceville
  • Asthma & Allergy Consultants, PC - Lilburn

Massachusetts

  • Medical Education and Research Management Services of New England - Gardner
  • Northeast Medical Research Associates, Inc. - North Dartmouth

North Carolina

  • Allergy and Asthma Center of NC, PA - High Point
  • North Carolina Clinical Research - Raleigh

Colorado

  • Storms Clinical Research Institute - Colorado Springs

Maryland

  • Gordon D Raphael, MD - Bethesda

Michigan

  • Respiratory Medicine Research Institute of Michigan, PLC - Ypsilanti

Trial Details

FieldValue
Enrollment Target 737 participants
Start Date 2012-09
Est. Completion 2013-07
Phase Phase 4

Sponsor

Sumitomo Pharma America

168 total trials

What the Registry Record Tells You About NCT01654536

The ClinicalTrials.gov registry entry for NCT01654536 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 737 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 427-participant average among 4 other Perennial Allergic Rhinitis trials with a reported enrollment target (73% higher). The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Perennial Allergic Rhinitis appearing as the primary indexed condition, and to 2 interventions - of which ciclesonide nasal aerosol is the first listed.

NCT01654536 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, New Jersey, Georgia.

Frequently Asked Questions

What is clinical trial NCT01654536 about?

NCT01654536 is a clinical study titled "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)". This is a 6 month, multicenter, randomized, open label, parallel group, study to evaluate the nasal safety of ciclesonide nasal aerosol and ciclesonide aqueous nasal spray administered once daily to male and female subjects 12 years and older diagnosed with PAR.

What is the current status of trial NCT01654536?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 737 participants. The study started on 2012-09. Estimated completion is 2013-07.

What conditions does trial NCT01654536 study?

This clinical trial studies the following conditions: Perennial Allergic Rhinitis.

What interventions are being tested in trial NCT01654536?

The interventions under investigation include: ciclesonide nasal aerosol (DRUG), ciclesonide nasal spray (DRUG).

Who is sponsoring clinical trial NCT01654536?

This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01654536 being conducted?

This trial has 20 study locations across California, Colorado, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Perennial Allergic Rhinitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.