Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 Mcg in Allergic Rhinitis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

ClinicalTrials.gov Identifier:

NCT00988247

First received: September 30, 2009

Last updated: April 23, 2012

Last verified: April 2012

History of Changes

Results First Received: April 23, 2012

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
Condition:	Rhinitis, Allergic, Perennial
Interventions:	Drug: Beclomethasone dipropionate Drug: Placebo Nasal Aerosol

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 857 patients were screened and 775 patients were enrolled in the study and participated in the Run-in Period. Of the 775 enrolled patients, 529 were randomized to study treatment.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the 7 to 21 day Run-in Period, participants self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their daily seasonal rhinitis symptoms to determine eligibility for randomization.

Reporting Groups

	Description
BDP HFA 320 µg/Day	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
Placebo	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.

Participant Flow: Overall Study

	BDP HFA 320 µg/Day	Placebo
STARTED	418	111
Safety Population	415 ^[1]	111 ^[1]
Intent to Treat Population	414 ^[2]	110 ^[2]
COMPLETED	335	85
NOT COMPLETED	83	26
Adverse Event	17	3
Withdrawal by Subject	44	13
Pregnancy	1	2
Lost to Follow-up	11	2
Protocol Violation	4	5
Sponsor requested withdrawal	3	1
Not specified	3	0

[1]	Participants who received at least 1 dose of study drug
[2]	Participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment

Baseline Characteristics

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Reporting Groups

	Description
BDP HFA 320 µg/Day	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
Placebo	During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Total	Total of all reporting groups

Baseline Measures

	BDP HFA 320 µg/Day	Placebo	Total
Number of Participants [units: participants]	414	110	524
Age ^[1] [units: years] Mean ± Standard Deviation	37.4 ± 13.6	35.7 ± 12.9	37.1 ± 13.4
Gender [units: participants]
Female	286	66	352
Male	128	44	172
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	45	12	57
Not Hispanic or Latino	369	98	467
Unknown or Not Reported	0	0	0
Race/Ethnicity, Customized ^[2] [units: participants]
American Indian or Alaska Native	7	2	9
Asian	13	1	14
Native Hawaiian or Other Pacific Islander	3	0	3
Black or African American	63	14	77
White	341	97	438
Unknown or Not Reported	1	0	1
Body mass index [units: kg/m^2] Mean ± Standard Deviation	28.8 ± 6.7	28.4 ± 6.7	28.7 ± 6.7

[1]	Demographic data are provided for the Intent to Treat population.
[2]	A participant may select more than one race type.

Outcome Measures

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1. Primary:

Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 30 ]

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2. Secondary:

Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 30 ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 52 ]

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4. Secondary:

Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks [ Time Frame: Baseline (Days -6 to 0), Day 1 to Week 52 ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline [ Time Frame: Day 0 (Baseline) and Week 30 ]

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6. Secondary:

Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline [ Time Frame: Day 0 (Baseline) and Week 52 ]

Show Outcome Measure 6

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com

Publications of Results:

Meltzer EO, Jacobs RL, LaForce CF, Kelley L, Dunbar SA, Tantry SK. Safety and Efficacy of Once Daily Treatment With beclomethasone dipropionate nasal aerosol in Subjects With Perennial Allergic Rhinitis. Allergy Asthma Proc (2012) (E-Pub)

Meltzer EO, Jacobs RL, LaForce CF, Dorinsky PM, Kelley L, Dunbar SA, Tantry SK. . BDP HFA Nasal Aerosol 320 µg Once Daily Is Safe and Effective in the Treatment of Nasal Symptoms Associated With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol 2011 (Supplement); 107(11):A118 - Poster presentation.

Responsible Party:	Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:	NCT00988247 History of Changes
Other Study ID Numbers:	BDP-AR-303
Study First Received:	September 30, 2009
Results First Received:	April 23, 2012
Last Updated:	April 23, 2012
Health Authority:	United States: Food and Drug Administration

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