NCT00854360|CompletedPhase 2Results

Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR

Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Range-Finding Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Adult and Adolescent Patients (12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

Teva Branded Pharmaceutical Products R&D, Inc.ClinicalTrials.gov

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1 other identifier

BDP-AR-201

Study Type

interventional

Target

487

Locations

1 country

Sites

Timeline

RegisteredMar 2009

StartedMar 2009

CompletionMay 2009

Brief Summary

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.

Trial Health

On Track

Trial Health Score

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

Enrollment

487

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Mar 2009

Shorter than P25 for phase_2

Geographic Reach

1 country

26 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

2 months study duration

Study Start

First participant enrolled

March 1, 2009

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

May 22, 2012

Completed

Last Updated

May 22, 2012

Status Verified

April 1, 2012

Enrollment Period

2 months

First QC Date

March 2, 2009

Results QC Date

April 23, 2012

Last Update Submit

April 23, 2012

Conditions

Seasonal Allergic Rhinitis Hayfever

Keywords

Seasonal Allergic RhinitisHayfever

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Average 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, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Secondary Outcomes (5)

Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period
Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Baseline and Week 2
Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period
Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period
Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Study Arms (4)

BDP HFA 80 µg/day

EXPERIMENTAL

During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily.

Drug: Beclomethasone dipropionate HFA Nasal AerosolDrug: Placebo

BDP HFA 160 µg/day

EXPERIMENTAL

During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.

Drug: Beclomethasone dipropionate HFA Nasal Aerosol

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.

Drug: Beclomethasone dipropionate HFA Nasal Aerosol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Beclomethasone dipropionate HFA Nasal AerosolDRUG

Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol

Also known as: QNASL(TM)

BDP HFA 160 µg/dayBDP HFA 320 µg/dayBDP HFA 80 µg/day

PlaceboDRUG

HFA Vehicle Aerosol

BDP HFA 80 µg/dayPlacebo

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Male or female patients 12 years of age and older, as of the Screening Visit (SV).
General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the investigator's judgment is expected to be exposed to the allergen and require treatment throughout the entire study period.
A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result within 12 months prior to Screening Visit (SV) is acceptable.
Other criteria apply

You may not qualify if:

Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study.
History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the SV).
History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)\] within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
Use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the Screening Visit (SV) and/or plans for use during the entire treatment duration.
Other criteria apply

Contact the study team to confirm eligibility.