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COMPLETED Phase 3

Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

NCT01307319 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).

Interventions

  • DRUG BDP HFA
  • DRUG Placebo nasal aerosol

Study Locations (20)

California

  • Teva Clinical Study Site — Bell
  • Teva Clinical Study Site — Costa Mesa
  • Teva Clinical Study Site — Mission Viejo
  • Teva Clinical Study Site — Orange
  • Teva Clinical Study Site — Paramount
  • Teva Clinical Study Site — San Diego
  • Teva Clinical Study Site — San Diego
  • Teva Clinical Study Site — Stockton

Georgia

  • Teva Clinical Study Site — Gainesville
  • Teva Clinical Study Site — Lawrenceville
  • Teva Clinical Study Site — Savannah
  • Teva Clinical Study Site — Stockbridge

Colorado

  • Teva Clinical Study Site — Centennial
  • Teva Clinical Study Site — Colorado Springs

Minnesota

  • Teva Clinical Study Site — Minneapolis
  • Teva Clinical Study Site — Plymouth

Alabama

  • Teva Clinical Study Site — Oxford

Indiana

  • Teva Clinical Study Site — Indianapolis

Maryland

  • Teva Clinical Study Site — Bethesda

Missouri

  • Teva Clinical Study Site — Columbia

Trial Details

FieldValue
Enrollment Target 715 participants
Start Date 2011-03
Est. Completion 2011-08
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01307319

The ClinicalTrials.gov registry entry for NCT01307319 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 715 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 103 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Seasonal Allergic Rhinitis appearing as the primary indexed condition, and to 2 interventions — of which BDP HFA 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: NCT01307319 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Georgia, Colorado. 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 NCT01307319 about?

NCT01307319 is a clinical study titled "Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies". The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).

What is the current status of trial NCT01307319?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 715 participants. The study started on 2011-03. Estimated completion is 2011-08.

What conditions does trial NCT01307319 study?

This clinical trial studies the following conditions: Seasonal Allergic Rhinitis, SAR. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01307319?

The interventions under investigation include: BDP HFA (DRUG), Placebo nasal aerosol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01307319?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 103 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01307319 being conducted?

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

Related

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