Trial Outcomes & Findings for Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR) (NCT NCT01133626)

Last Updated: 2012-07-04

Results Overview

Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an "other pre-specified" outcome.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

107 participants

Primary outcome timeframe

Day 0 (Baseline), Day 42

Results posted on

2012-07-04

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	50	46	11
Overall Study Safety Population	50	46	11
Overall Study Per Protocol Population	48	41	9
Overall Study COMPLETED	49	41	9
Overall Study NOT COMPLETED	1	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	0	1	0
Overall Study Withdrawal by Subject	1	2	2
Overall Study Other	0	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BDP HFA 320 µg/Day n=48 Participants 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 n=41 Participants 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 n=9 Participants 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 n=98 Participants Total of all reporting groups
Age Continuous	28.3 years STANDARD_DEVIATION 10.0 • n=5 Participants	26.6 years STANDARD_DEVIATION 10.6 • n=7 Participants	26.2 years STANDARD_DEVIATION 11.9 • n=5 Participants	27.4 years STANDARD_DEVIATION 10.4 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	22 Participants n=7 Participants	7 Participants n=5 Participants	54 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	19 Participants n=7 Participants	2 Participants n=5 Participants	44 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	18 participants n=5 Participants	17 participants n=7 Participants	2 participants n=5 Participants	37 participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	30 participants n=5 Participants	24 participants n=7 Participants	7 participants n=5 Participants	61 participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	7 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	10 participants n=4 Participants
Race/Ethnicity, Customized White	42 participants n=5 Participants	38 participants n=7 Participants	7 participants n=5 Participants	87 participants n=4 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Body Mass Index	27.9 kg/m^2 STANDARD_DEVIATION 7.9 • n=5 Participants	27.0 kg/m^2 STANDARD_DEVIATION 6.2 • n=7 Participants	28.4 kg/m^2 STANDARD_DEVIATION 7.9 • n=5 Participants	27.6 kg/m^2 STANDARD_DEVIATION 7.2 • n=4 Participants

PRIMARY outcome

Timeframe: Day 0 (Baseline), Day 42

Population: Per protocol population

Outcome measures

Outcome measures
Measure	BDP HFA 320 µg/Day n=48 Participants 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 n=41 Participants 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 n=9 Participants 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.
The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment	0.90 ratio Standard Error 1.04	0.95 ratio Standard Error 1.03	0.31 ratio Standard Error 1.14

Adverse Events

BDP HFA 320 µg/Day

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo/Prednisone

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BDP HFA 320 µg/Day n=50 participants at risk 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 n=46 participants at risk 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 n=11 participants at risk 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.
Infections and infestations Gastroenteritis	0.00% 0/50	0.00% 0/46	9.1% 1/11
Investigations Blood oestrogen increased	0.00% 0/50	0.00% 0/46	9.1% 1/11
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/50	0.00% 0/46	9.1% 1/11
Respiratory, thoracic and mediastinal disorders Epistaxis	4.0% 2/50	2.2% 1/46	9.1% 1/11
Respiratory, thoracic and mediastinal disorders Nasal discomfort	2.0% 1/50	4.3% 2/46	9.1% 1/11

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc.

Phone: 215-591-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER