Phase 3
N=715
Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
Seasonal Allergic Rhinitis · SAR
Bottom Line
View on ClinicalTrials.gov: NCT01307319 ↗Enrolled (actual)
715
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment — -1.9; -2.0; -1.2 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BDP HFA (Drug); Placebo nasal aerosol (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment |
-1.9; -2.0; -1.2 | <0.001 sig |
| SECONDARY Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment |
-1.6; -1.7; -1.0 | <0.001 sig |
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).
Eligibility Criteria
Inclusion Criteria
- Male or female subjects 6 to 11 years of age, as of the Screening Visit (SV)
- A documented history of SAR to a relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV).
- A demonstrated sensitivity to at least one seasonal allergen (tree/grass pollen) known to induce SAR through a standard skin prick test.
- Other criteria apply
Exclusion Criteria
- History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit [SV])
- History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis or influenza,) within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
- Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drug (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable
- Have any conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial
- Other criteria apply
Data sourced from ClinicalTrials.gov (NCT01307319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.