Rhinitis, Allergic, Perennial
Conditions
Brief summary
The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of perennial allergic rhinitis.
Interventions
DRUGBeclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
HFA Vehicle Aerosol
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed Consent * Documented history of perennial allergic rhinitis * A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test. * Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12) * Other criteria apply
Exclusion criteria
* History of physical findings of nasal pathology (within 60 days prior to screening visit) * Participation in any investigational drug study 30 days preceding screening visit * History of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period * Use of any prohibited concomitant medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period | Baseline (Days -3 to 0) and Days 1-43 (6-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, awareness, 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 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period | Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period) | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM & PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (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. |
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Baseline and Week 6 | The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement. |
Countries
United States
Participant flow
Recruitment details
A total of 675 patients were screened and 574 patients were enrolled in the study and participated in the Run-in Period. Of the 574 enrolled patients, 474 were randomized to study treatment.
Pre-assignment details
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 twice daily allergic rhinitis symptoms to determine eligibility for randomization.
Participants by arm
| Arm | Count |
|---|---|
| BDP HFA 320 µg/Day During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. | 232 |
| Placebo During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily. | 234 |
| Total | 466 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 7 |
| Overall Study | Lost to Follow-up | 5 | 2 |
| Overall Study | Other | 1 | 6 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | BDP HFA 320 µg/Day | Placebo | Total |
|---|---|---|---|
| Age Continuous | 36.8 years STANDARD_DEVIATION 14.5 | 37.2 years STANDARD_DEVIATION 13.7 | 37.0 years STANDARD_DEVIATION 14.1 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Asian | 6 participants | 5 participants | 11 participants |
| Race/Ethnicity, Customized Black or African American | 40 participants | 40 participants | 80 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 26 participants | 30 participants | 56 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 206 participants | 204 participants | 410 participants |
| Race/Ethnicity, Customized Other | 1 participants | 6 participants | 7 participants |
| Race/Ethnicity, Customized White | 186 participants | 185 participants | 371 participants |
| Region of Enrollment United States | 232 participants | 234 participants | 466 participants |
| Sex: Female, Male Female | 158 Participants | 161 Participants | 319 Participants |
| Sex: Female, Male Male | 74 Participants | 73 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 236 | 12 / 238 |
| serious Total, serious adverse events | 1 / 236 | 0 / 238 |
Outcome results
Primary
Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-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, awareness, 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 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Time frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Population: Intent-to-Treat (ITT) Population: The ITT population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BDP HFA 320 µg/Day | Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period | -2.5 units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period | -1.6 units on a scale | Standard Error 0.14 |
p-value: <0.00195% CI: [-1.2, -0.5]Repeated measures Analysis of covariance
Secondary
Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM & PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (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.
Time frame: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
Population: Intent to treat population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BDP HFA 320 µg/Day | Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period | -2.1 units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period | -1.4 units on a scale | Standard Error 0.13 |
p-value: <0.00195% CI: [-1.1, -0.4]Repeated measures ANCOVA
Secondary
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement.
Time frame: Baseline and Week 6
Population: The RQLQ population included adults (18 years and older) with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BDP HFA 320 µg/Day | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | -1.5 units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | -0.9 units on a scale | Standard Error 0.14 |
p-value: 0.00195% CI: [-0.9, -0.2]ANCOVA