Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01307319 · ClinicalTrials.gov registry record · Phase 3
Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
A Phase 3 study of Seasonal Allergic Rhinitis and SAR, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 715
- Enrollment target
- 20
- Study locations
NCT01307319: Completed Phase 3 study of Seasonal Allergic Rhinitis and SAR, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01307319 is a Phase 3 study of Seasonal Allergic Rhinitis and SAR that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 715 participants, above the 623-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01307319, a Phase 3 study of Seasonal Allergic Rhinitis and SAR, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 715 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: * 0 = absent (no sign/symptom present) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 715 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT01307319 record still lists
NCT01307319 is an interventional study that assigns participants to a tested intervention. The registered 715 participants enrollment target is mid-sized for trials with a published cap, above the 623-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (15% higher).
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.
NCT01307319 names 20 study sites across 8 states, led by California, Georgia, Colorado.
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.
What interventions are being tested in trial NCT01307319?
The interventions under investigation include: BDP HFA (DRUG), Placebo nasal aerosol (DRUG).
Who is sponsoring clinical trial NCT01307319?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Seasonal 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.
Where NCT01307319's enrollment target sits among peer trials
715 6th of 16 higher than 11 of 16 other Seasonal Allergic Rhinitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Seasonal Allergic Rhinitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
COMPLETED · Phase 3
-
Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)
COMPLETED · Phase 3
-
A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
COMPLETED · Phase 3
-
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
COMPLETED · Phase 3
-
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Seasonal Allergic Rhinitis (SAR)
COMPLETED · Phase 3
-
Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using mEECs™
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04680000 · 716 participants · NA
Chronic Pain Management In Primary Care Using Behavioral Health Consultants
- NCT05208762 · 714 participants · Phase 1
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
- NCT06758401 · 714 participants · Phase 3
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
- NCT04916327 · 720 participants · NA
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia