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Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)

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ClinicalTrials.gov Identifier: NCT01697956
Recruitment Status : Completed
First Posted : October 2, 2012
Results First Posted : October 8, 2015
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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Brief Summary:
The purpose of this study is to compare the effect of 6 weeks of treatment with beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and tolerability of BDP nasal aerosol, in subjects 6 to 11 years of age with perennial allergic rhinitis.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: BDP Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA)-Axis in Pediatric Subjects (6 to 11 Years of Age) With Perennial Allergic Rhinitis (PAR)
Study Start Date : October 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 42 day (6 week) Treatment Period.
 Drug: BDP
Beclomethasone dipropionate (BDP) 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.
Other Names:
  • QNASL®
  • Beclomethasone dipropionate
Placebo Comparator: Placebo Nasal Aerosol
Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
 Drug: Placebo
Placebo (1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment [ Time Frame: Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration) ]
    The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived.


Secondary Outcome Measures :
  1. Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) [ Time Frame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) ]
    Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.

  2. Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) [ Time Frame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) ]
    Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.

  3. Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) [ Time Frame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) ]
    Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.

  4. Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP) [ Time Frame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) ]
    Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.

  5. Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP) [ Time Frame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) ]
    Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.

  6. Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP) [ Time Frame: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration) ]
    Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.

  7. Participants With Treatment-Emergent Adverse Events (AEs) [ Time Frame: Day 1- week 10 ]

    The intensity or severity of the AE was characterized as mild (AE which is easily tolerated), moderate (AE sufficiently discomforting to interfere with daily activity) or severe (AE which prevents normal daily activities).

    The causal relationship was characterized as not related (no reasonable possibility that the AE was caused by or attributed to the investigational product) or related reasonable possibility that the AE was caused by or attributed to the investigational product / a causal relationship cannot be ruled out).

    An SAE was defined as an AE that resulted in any of the following:

    • Death
    • Life-threatening
    • Required hospitalization or prolonged existing hospitalization
    • Persistent or significant disability or incapacity
    • A congenital abnormality or birth defect
    • An important medical event which required medical intervention to prevent any of the above outcomes.

  8. Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study [ Time Frame: Screening (Day -21 to -7), End of Study (Day 42) ]

    Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.

    MCHC = mean corpuscular hemoglobin concentration MCV = mean corpuscular volume, or mean cell volume MCH = mean corpuscular hemoglobin or mean cell hemoglobin


  9. Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study [ Time Frame: Screening (Day -21 to -7), End of Study (Day 42) ]

    Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.

    BUN = blood urea nitrogen AST = aspartate transaminase ALT = alanine transaminase GGT = gamma-glutamyl transpeptidase



Eligibility Criteria
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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent/(assent - if applicable)
  • Male or female subjects 6-11 years of age
  • General good health
  • A documented history of PAR to a relevant perennial allergen for a minimum of 12 months
  • Other criteria apply

Exclusion Criteria:

  • Pregnancy, nursing, or plans to become pregnant or donate gametes
  • Participation in any investigational drug study within the 30 days preceding the Screening Visit 1 (SV1)
  • Previous participation in a BDP nasal aerosol study as a randomized subject
  • A known hypersensitivity to any corticosteroid or any of the excipients in the study medication formulation
  • History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations
  • History of a respiratory infection or disorder within the 14 days preceding the Screening Visit 1 (SV1)
  • Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to the Screening Visit 1 (SV1)
  • Other criteria apply
  • Current smoker or current user of tobacco products at any time during the study; history of smoking or use of tobacco products within the past year
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697956


Locations
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United States, California
Teva Investigational Site 10305
Long Beach, California, United States
United States, Georgia
Teva Investigational Site 10304
Stockbridge, Georgia, United States
United States, Minnesota
Teva Investigational Site 10300
Plymouth, Minnesota, United States
United States, Pennsylvania
Teva Investigational Site 10302
Normal, Pennsylvania, United States
United States, Texas
Teva Investigational Site 10301
New Braunfels, Texas, United States
Teva Investigational Site 10303
San Antonio, Texas, United States
Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Principal Investigator: Sudeesh K Tantry, Ph.D. Teva Branded Pharmaceutical Products R&D
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT01697956    
Other Study ID Numbers: BDP-AR-307
First Posted: October 2, 2012    Key Record Dates
Results First Posted: October 8, 2015
Last Update Posted: October 8, 2015
Last Verified: September 2015
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:
Pediatric Subjects
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
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