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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307319
• Other study ID #: BDP-AR-305
• Status: Completed
• Phase: Phase 3
• First received: February 28, 2011
• Last updated: February 3, 2015
• Start date: March 2011
• Est. completion date: August 2011

Study information

• Verified date: February 2015
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 715
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal
• SAR
• Seasonal Allergic Rhinitis

Intervention

Drug:
• BDP HFA
BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.
• Placebo nasal aerosol
Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.

Locations

Country	Name	City	State
United States	Teva Clinical Study Site	Austin	Texas
United States	Teva Clinical Study Site	Bell	California
United States	Teva Clinical Study Site	Bethesda	Maryland
United States	Teva Clinical Study Site	Blue Bell	Pennsylvania
United States	Teva Clinical Study Site	Bozeman	Montana
United States	Teva Clinical Study Site	Brick	New Jersey
United States	Teva Clinical Study Site	Burke	Virginia
United States	Teva Clinical Study Site	Centennial	Colorado
United States	Teva Clinical Study Site	Charleston	South Carolina
United States	Teva Clinical Study Site	Collegeville	Pennsylvania
United States	Teva Clinical Study Site	Colorado Springs	Colorado
United States	Teva Clinical Study Site	Columbia	Missouri
United States	Teva Clinical Study Site	Costa Mesa	California
United States	Teva Clinical Study Site	Dallas	Texas
United States	Teva Clinical Study Site	Dallas	Texas
United States	Teva Clinical Study Site	El Paso	Texas
United States	Teva Clinical Study Site	Ft. Worth	Texas
United States	Teva Clinical Study Site	Gainesville	Georgia
United States	Teva Clinical Study Site	High Point	North Carolina
United States	Teva Clinical Study Site	Houston	Texas
United States	Teva Clinical Study Site	Indianapolis	Indiana
United States	Teva Clinical Study Site	Kerrville	Texas
United States	Teva Clinical Study Site	Lawrenceville	Georgia
United States	Teva Clinical Study Site	Minneapolis	Minnesota
United States	Teva Clinical Study Site	Mission Viejo	California
United States	Teva Clinical Study Site	New Braunfels	Texas
United States	Teva Clinical Study Site	Oklahoma City	Oklahoma
United States	Teva Clinical Study Site	Orange	California
United States	Teva Clinical Study Site	Orangeburg	South Carolina
United States	Teva Clinical Study Site	Oxford	Alabama
United States	Teva Clinical Study Site	Paramount	California
United States	Teva Clinical Study Site	Philadelphia	Pennsylvania
United States	Teva Clinical Study Site	Pittsburgh	Pennsylvania
United States	Teva Clinical Study Site	Plymouth	Minnesota
United States	Teva Clinical Study Site	Portland	Oregon
United States	Teva Clinical Study Site	Richmond	Virginia
United States	Teva Clinical Study Site	Rolla	Missouri
United States	Teva Clinical Study Site	San Antonio	Texas
United States	Teva Clinical Study Site	San Diego	California
United States	Teva Clinical Study Site	San Diego	California
United States	Teva Clinical Study Site	Savannah	Georgia
United States	Teva Clinical Study Site	Stockbridge	Georgia
United States	Teva Clinical Study Site	Stockton	California
United States	Teva Clinical Study Site	Waco	Texas
United States	Teva Clinical Study Site	Warrensburg	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products, R&D Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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 of sign/symptom that is bothersome but tolerable); 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.; Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization.	Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15	No
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	Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes 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 of sign/symptom that is bothersome but tolerable); 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.; Baseline was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization.	Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15	No