NCT01024608

Brief Summary

The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
28 days until next milestone

Study Start

First participant enrolled

December 31, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2010

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 23, 2012

Completed
Last Updated

December 3, 2021

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

December 2, 2009

Results QC Date

April 23, 2012

Last Update Submit

December 1, 2021

Conditions

Seasonal Allergic RhinitisHay Fever

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period

    Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping). The rTNSS (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement.

    Baseline (Days -3 to 0), and Days 1-15

Secondary Outcomes (3)

  • Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period

    Baseline (Days -3 to 0), and Days 1-15

  • Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline

    Day 0 (Baseline), Day 15

  • Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period

    Baseline (Days -3 to 0), and Days 1-15

Study Arms (2)

BDP HFA 320 µg/day

EXPERIMENTAL

During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning.

Drug: Beclomethasone dipropionate

Placebo

PLACEBO COMPARATOR

During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.

Drug: Placebo Nasal Aerosol

Interventions

Beclomethasone dipropionateDRUG

Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks.

Also known as: QNASL(TM)
BDP HFA 320 µg/day
Placebo Nasal AerosolDRUG

Placebo nasal aerosol administered each morning for two weeks.

Placebo

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent
  • Male or female subjects 12 years of age or older
  • Documented history of season allergic rhinitis to mountain cedar pollen
  • General good health
  • Other criteria apply

You may not qualify if:

  • History of physical findings of nasal pathology (within 60 days prior to screening visit)
  • Participation in any investigational drug study 30 days preceding screening visit
  • History of respiratory infection/disorder with 14 days preceding screening visit
  • Use of any prohibited concomitant medications
  • Other criteria apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Teva Clinical Trial Site

Austin, Texas, 78731, United States

Location

Teva Clinical Trial Site

New Braunfels, Texas, 78130, United States

Location

Teva Clinical Trial Site

San Antonio, Texas, 78229, United States

Location

Teva Clinical Trial Site

Waco, Texas, 76712, United States

Location

Related Publications (5)

  • Van Bavel J, Ratner PH, Amar NJ, Hampel FC, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily Effectively Improves Ocular Symptoms Associated With Seasonal Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.

    RESULT

  • Van Bavel J, Dorinsky PM, Melchior A, Dunbar SA, and Tantry SK (2011). Nasal Symptom Relief and Improvement in Health-Related Quality of Life Following Treatment with BDP HFA Nasal Aerosol (320 mcg Once Daily) in Subjects with Seasonal Allergic Rhinitis. Allergy Asthma Proc. 32(4):330.

    RESULT

  • Van Bavel J, Hampel, FC, Ratner PH, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2011). BDP HFA Nasal Aerosol Effectively Improves Nasal Symptom Relief and Health-Related Quality of Life (QOL) in Subjects with Seasonal Allergic Rhinitis (SAR). J Allergy Clin Immunol. 127(2):201.

    RESULT

  • Van Bavel J, Amar NJ, Melchior A, Dunbar SA, Tantry SK and Dorinsky PM (2010).BDP HFA Nasal Aerosol, 320 mcg Once Daily, is Safe and Effective in the Treatment of Nasal Symptoms Associated with Seasonal Allergic Rhinitis (SAR). Ann Allergy Asthma Immunol. 105(5):121.

    RESULT

  • van Bavel JH, Ratner PH, Amar NJ, Hampel FC Jr, Melchior A, Dunbar SA, Dorinsky PM, Tantry SK. Efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2012 Sep-Oct;33(5):386-96. doi: 10.2500/aap.2012.33.3593.

    PMID: 23026180DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Results Point of Contact

Title
Director, Clinical Research
Organization
Teva Branded Pharmaceutical Products, R&D Inc.
ustevatrials@tevapharm.com
215-591-3000

Study Officials

  • Sudeesh Tantry, Ph.D.

    Teva Branded

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

December 31, 2009

Primary Completion

February 28, 2010

Study Completion

February 28, 2010

Last Updated

December 3, 2021

Results First Posted

May 23, 2012

Record last verified: 2021-12

Locations

US(4)