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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: SAR; Seasonal Allergic Rhinitis

Treatments: Drug: Placebo nasal aerosol; Drug: BDP HFA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01307319

BDP-AR-305

Details and patient eligibility

About

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).

Enrollment: 715 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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715 participants in 3 patient groups, including a placebo group

BDP HFA 80 mcg/day

Experimental group

Description:

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

Treatment:

Drug: BDP HFA

BDP HFA 160 mcg/day

Experimental group

Description:

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

Treatment:

Drug: BDP HFA

Placebo nasal aerosol once daily

Placebo Comparator group

Description:

Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.

Treatment:

Drug: Placebo nasal aerosol