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

Brief Title

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

Official Title

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

Brief 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).
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 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

Condition

Seasonal Allergic Rhinitis

Intervention

BDP HFA

Study Arms / Comparison Groups

 BDP HFA 80 mcg/day
Description:  Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

715

Start Date

March 2011

Completion Date

August 2011

Primary Completion Date

July 2011

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
      

Gender

All

Ages

6 Years - 11 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01307319

Organization ID

BDP-AR-305


Responsible Party

Sponsor

Study Sponsor

Teva Branded Pharmaceutical Products, R&D Inc.


Study Sponsor

, , 


Verification Date

February 2015