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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT01133626

First received: May 27, 2010

Last updated: May 31, 2012

Last verified: May 2012

History of Changes

Results First Received: April 23, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Perennial Allergic Rhinitis
Interventions:	Drug: Placebo Nasal Aerosol Drug: Prednisone capsules Drug: Placebo Prednisone Capsules Drug: Beclomethasone dipropionate

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 139 patients were screened and 128 patients were enrolled in the study and participated in the Run-in Period. Of the 128 enrolled patients, 107 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 14 day Run-in Period (prior to randomization), participants self-administered a single-blind placebo nasal aerosol once daily in the morning.

Reporting Groups

	Description
BDP HFA 320 µg/Day	Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
Placebo	Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
Placebo/Prednisone	Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.

Participant Flow: Overall Study

	BDP HFA 320 µg/Day	Placebo	Placebo/Prednisone
STARTED	50	46	11
Safety Population	50 ^[1]	46 ^[1]	11 ^[1]
Per Protocol Population	48 ^[2]	41 ^[2]	9 ^[2]
COMPLETED	49	41	9
NOT COMPLETED	1	5	2
Adverse Event	0	1	0
Withdrawal by Subject	1	2	2
Not specified	0	2	0

[1]	Participants who received at least 1 dose of study drug
[2]	Received >=1 dose of study drug and >=1 post-baseline assessment prior to major protocol deviation.

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
BDP HFA 320 µg/Day	Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
Placebo	Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
Placebo/Prednisone	Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
Total	Total of all reporting groups

Baseline Measures

	BDP HFA 320 µg/Day	Placebo	Placebo/Prednisone	Total
Number of Participants [units: participants]	48	41	9	98
Age ^[1] [units: years] Mean ± Standard Deviation	28.3 ± 10.0	26.6 ± 10.6	26.2 ± 11.9	27.4 ± 10.4
Gender [units: participants]
Female	25	22	7	54
Male	23	19	2	44
Race/Ethnicity, Customized [units: participants]
Hispanic or Latino	18	17	2	37
Not Hispanic or Latino	30	24	7	61
Race/Ethnicity, Customized ^[2] [units: participants]
American Indian or Alaska Native	0	0	1	1
Asian	1	0	0	1
Black or African American	7	2	1	10
White	42	38	7	87
Unknown or Not Reported	0	1	0	1
Body Mass Index [units: kg/m^2] Mean ± Standard Deviation	27.9 ± 7.9	27.0 ± 6.2	28.4 ± 7.9	27.6 ± 7.2

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

Outcome Measures

1. Primary:

The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment [ Time Frame: Day 0 (Baseline), Day 42 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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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.

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:

Hampel FC, Ratner PH, Miller SD, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Once-daily treatment with beclomethasone dipropionate hydrofluoroalkane nasal aerosol (320 mcg/d) is not associated with hypothalamic-pituitary-adrenal axis suppression in adolescent subjects with perennial allergic rhinitis. J Allergy Clin Immunol 2012; 129:AB188

Ratner PH, Miller SD, Hampel FC, A, Dunbar SA, Tantry SK, Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 μg Once Daily g Once Daily Is Not Associated with HPA-Axis Suppression in Subjects With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11):A118.

Publications automatically indexed to this study:

Ratner PH, Miller SD, Hampel FC Jr, Melchior A, Dunbar SA, Tantry SK. Once-daily treatment with beclomethasone dipropionate nasal aerosol does not affect hypothalamic-pituitary-adrenal axis function. Ann Allergy Asthma Immunol. 2012 Nov;109(5):336-41. doi: 10.1016/j.anai.2012.08.005.

Responsible Party:	Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:	NCT01133626 History of Changes
Other Study ID Numbers:	BDP-AR-304
Study First Received:	May 27, 2010
Results First Received:	April 23, 2012
Last Updated:	May 31, 2012
Health Authority:	United States: Food and Drug Administration

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