Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies
This study has been completed.
Sponsor:
Teva Branded Pharmaceutical Products, R&D Inc.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01307319
First received: February 28, 2011
Last updated: August 17, 2012
Last verified: August 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis (SAR) |
Drug: BDP nasal aerosol - 80 microgram dose once daily Drug: BDP nasal aerosol - 160 microgram dose once daily Drug: Placebo Nasal Aerosol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Study of Two Doses of an Investigational Nasal Aerosol Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies |
Resource links provided by NLM:
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- Average AM and PM subject-reported reflective Total Nasal Symptom Score (TNSS) over the two-week Treatment Period [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Average AM and PM subject-reported instantaneous TNSS over the two-week Treatment Period [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 715 |
| Study Start Date: | March 2011 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 80 micrograms once daily
Participants/parents will administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) per day for 15 days of treatment period
|
Drug: BDP nasal aerosol - 80 microgram dose once daily
Participants/parents will administer 40 micrograms BDP HFA (one spray per nostril) per day for 15 days of treatment period
|
|
Experimental: 160 micrograms once daily
Participants/parents will administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) per day for 15 days of treatment period
|
Drug: BDP nasal aerosol - 160 microgram dose once daily
Participants/parents will administer 80 micrograms BDP HFA per nostril per day for 15 days of treatment period
|
|
Placebo Comparator: Placebo once daily
Participants/parents will administer placebo (a spray with no medication) per nostril per day for 15 days of treatment period
|
Drug: Placebo Nasal Aerosol
Participants/parents will administer placebo (no medication) spray HFA (one spray per nostril) per day for 15 days of treatment period
|
Eligibility| Ages Eligible for Study: | 6 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307319
Show 45 Study Locations
Show 45 Study LocationsSponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
More Information
No publications provided
| Responsible Party: | Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ) |
| ClinicalTrials.gov Identifier: | NCT01307319 History of Changes |
| Other Study ID Numbers: | BDP-AR-305 |
| Study First Received: | February 28, 2011 |
| Last Updated: | August 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Teva Pharmaceutical Industries:
|
Allergies Hayfever |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections |
Beclomethasone Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 21, 2013