Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)

Allergic Rhinitis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week, Clinical Study Designed to Assess the Efficacy and Safety of BDP Nasal Aerosol (80 mcg, Once Daily) in Pediatric Subjects (4 to 11 Years of Age) With PAR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783548
• Other study ID #: BDP-AR-306
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2013
• Last updated: September 11, 2015
• Start date: January 2013
• Est. completion date: October 2013

Study information

• Verified date: September 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 evaluate the efficacy and safety of Beclomethasone dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

Inclusion Criteria:

• Male or female subjects 4 to 11 years of age, inclusive, as of the Screening Visit (SV).

• A documented history of PAR to a relevant perennial allergen for a minimum of 12 months (6 months for subjects 4 to 5 years of age) immediately preceding the study Screening Visit (SV).

• A demonstrated sensitivity to at least one allergen known to induce PAR 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 of the following 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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• BDP Nasal Aerosol

• Placebo

Locations

Country	Name	City	State
United States	Teva Investigational Site 10537	Ashland	Oregon
United States	Teva Investigational Site 10477	Blue Bell	Pennsylvania
United States	Teva Investigational Site 10483	Boerne	Texas
United States	Teva Investigational Site 10507	Brick	New Jersey
United States	Teva Investigational Site 10519	Burke	Virginia
United States	Teva Investigational Site 10485	Canton	Ohio
United States	Teva Investigational Site 10514	Centennial	Colorado
United States	Teva Investigational Site 10497	Charleston	South Carolina
United States	Teva Investigational Site 10480	Cincinnati	Ohio
United States	Teva Investigational Site 10500	Cleveland	Ohio
United States	Teva Investigational Site 10503	Colorado Springs	Colorado
United States	Teva Investigational Site 10513	Columbia	Missouri
United States	Teva Investigational Site 10534	Corning	New York
United States	Teva Investigational Site 10492	Cortland	New York
United States	Teva Investigational Site 10518	Costa Mesa	California
United States	Teva Investigational Site 10489	Dallas	Texas
United States	Teva Investigational Site 10520	Dallas	Texas
United States	Teva Investigational Site 10509	Dekalb	Illinois
United States	Teva Investigational Site 10526	Downey	California
United States	Teva Investigational Site 10476	El Paso	Texas
United States	Teva Investigational Site 10478	High Point	North Carolina
United States	Teva Investigational Site 10516	Holly Springs	North Carolina
United States	Teva Investigational Site 10522	Hot Springs	Arkansas
United States	Teva Investigational Site 10496	Huntington Beach	California
United States	Teva Investigational Site 10536	Huntington Beach	California
United States	Teva Investigational Site 10486	Indianapolis	Indiana
United States	Teva Investigational Site 10491	Kerrville	Texas
United States	Teva Investigational Site 10528	Knoxville	Tennessee
United States	Teva Investigational Site 10499	Lawrenceville	Georgia
United States	Teva Investigational Site 10494	Louisville	Kentucky
United States	Teva Investigational Site 10527	Medford	Oregon
United States	Teva Investigational Site 10529	Middleburg Heights	Ohio
United States	Teva Investigational Site 10479	Mission Viejo	California
United States	Teva Investigational Site 10532	Missoula	Montana
United States	Teva Investigational Site 10517	Niagara Falls	New York
United States	Teva Investigational Site 10493	Normal	Illinois
United States	Teva Investigational Site 10515	North Dartmouth	Massachusetts
United States	Teva Investigational Site 10524	Orange	California
United States	Teva Investigational Site 10521	Orangeburg	South Carolina
United States	Teva Investigational Site 10508	Paramount	California
United States	Teva Investigational Site 10487	Plano	Texas
United States	Teva Investigational Site 10501	Plano	Texas
United States	Teva Investigational Site 10502	Portland	Oregon
United States	Teva Investigational Site 10481	Richmond	Virginia
United States	Teva Investigational Site 10533	Richmond	Virginia
United States	Teva Investigational Site 10482	Rochester	New York
United States	Teva Investigational Site 10488	Salt Lake City	Utah
United States	Teva Investigational Site 10506	Salt Lake City	Utah
United States	Teva Investigational Site 10510	Salt Lake City	Utah
United States	Teva Investigational Site 10523	San Antonio	Texas
United States	Teva Investigational Site 10531	San Antonio	Texas
United States	Teva Investigational Site 10539	San Antonio	Texas
United States	Teva Investigational Site 10495	San Diego	California
United States	Teva Investigational Site 10504	San Diego	California
United States	Teva Investigational Site 10474	Savannah	Georgia
United States	Teva Investigational Site 10490	Stockbridge	Georgia
United States	Teva Investigational Site 10498	Stockbridge	Georgia
United States	Teva Investigational Site 10505	Stockton	California
United States	Teva Investigational Site 10540	Traverse City	Michigan
United States	Teva Investigational Site 10484	Upland	Pennsylvania
United States	Teva Investigational Site 10475	Waco	Texas
United States	Teva Investigational Site 10511	Warwick	Rhode Island
United States	Teva Investigational Site 10535	Watertown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

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) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age	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 and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period.	Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6	No
Secondary	Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age	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 and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period.	Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6	No
Secondary	Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age	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 and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period.	Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6	No
Secondary	Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age	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 and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period.	Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6	No