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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01783548
First received: January 31, 2013
Last updated: September 11, 2015
Last verified: September 2015
  Purpose
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).

Condition Intervention Phase
Allergic Rhinitis
Drug: BDP Nasal Aerosol
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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 [ Time Frame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6 ] [ Designated as safety issue: No ]

    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.


  • 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 [ Time Frame: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6 ] [ Designated as safety issue: No ]

    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.


  • 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 [ Time Frame: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6 ] [ Designated as safety issue: No ]

    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.



Enrollment: 547
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BDP Nasal Aerosol 80 mcg/day
BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
Drug: BDP Nasal Aerosol
Other Names:
  • Beclomethasone dipropionate
  • QNASL®
Placebo Comparator: Placebo Nasal Aerosol
Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783548

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Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01783548     History of Changes
Other Study ID Numbers: BDP-AR-306 
Study First Received: January 31, 2013
Results First Received: July 27, 2015
Last Updated: September 11, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
allergic rhinitis
pediatric subjects
BDP nasal aerosol

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 24, 2016