Perennial Allergic Rhinitis
Conditions
Brief summary
The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.
Interventions
Placebo nasal aerosol administered daily for 42 days of treatment
DRUGPrednisone capsules
Prednisone 10 mg capsule taken each day on the last 7 days of treatment
Placebo prednisone capsule taken each day on the last 7 days of treatment
DRUGBeclomethasone dipropionate
Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Informed Consent * Male or female subjects 12-45 years of age * Documented history of perennial allergic rhinitis * General good health * Other criteria apply
Exclusion criteria
* History of physical findings of nasal pathology (within 60 days prior to Screening Visit 1) * Participation in any investigational drug study 30 days preceding Screening Visit 1 * History of respiratory infection/disorder with 14 days preceding Screening Visit 1 * Use of any prohibited concomitant medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment | Day 0 (Baseline), Day 42 | 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. |
Countries
United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 48 |
| 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. | 41 |
| 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. | 9 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Other | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 |
Baseline characteristics
| Characteristic | BDP HFA 320 µg/Day | Placebo | Placebo/Prednisone | Total |
|---|---|---|---|---|
| Age Continuous | 28.3 years STANDARD_DEVIATION 10 | 26.6 years STANDARD_DEVIATION 10.6 | 26.2 years STANDARD_DEVIATION 11.9 | 27.4 years STANDARD_DEVIATION 10.4 |
| Body Mass Index | 27.9 kg/m^2 STANDARD_DEVIATION 7.9 | 27.0 kg/m^2 STANDARD_DEVIATION 6.2 | 28.4 kg/m^2 STANDARD_DEVIATION 7.9 | 27.6 kg/m^2 STANDARD_DEVIATION 7.2 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 7 participants | 2 participants | 1 participants | 10 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 18 participants | 17 participants | 2 participants | 37 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 30 participants | 24 participants | 7 participants | 61 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 42 participants | 38 participants | 7 participants | 87 participants |
| Sex: Female, Male Female | 25 Participants | 22 Participants | 7 Participants | 54 Participants |
| Sex: Female, Male Male | 23 Participants | 19 Participants | 2 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 50 | 3 / 46 | 5 / 11 |
| serious Total, serious adverse events | 0 / 50 | 0 / 46 | 0 / 11 |
Outcome results
Primary
The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment
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.
Time frame: Day 0 (Baseline), Day 42
Population: Per protocol population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BDP HFA 320 µg/Day | The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment | 0.90 ratio | Standard Error 1.04 |
| Placebo | The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment | 0.95 ratio | Standard Error 1.03 |
| Placebo/Prednisone | The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment | 0.31 ratio | Standard Error 1.14 |
95% CI: [0.87, 1.06]ANCOVA