Seasonal Allergic Rhinitis, Hay Fever
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 seasonal allergic rhinitis.
Interventions
DRUGBeclomethasone dipropionate
Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks.
Placebo nasal aerosol administered each morning for two weeks.
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 * Male or female subjects 12 years of age or older * Documented history of season allergic rhinitis to mountain cedar pollen * General good health * 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 * Use of any prohibited concomitant medications * Other criteria apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period | Baseline (Days -3 to 0), and Days 1-15 | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping). The rTNSS (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 Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period | Baseline (Days -3 to 0), and Days 1-15 | Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The iTNSS (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 at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | Day 0 (Baseline), Day 15 | The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of 'emotional' utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement. |
| Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period | Baseline (Days -3 to 0), and Days 1-15 | Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities). The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement. |
Countries
United States
Participant flow
Recruitment details
A total of 484 patients were screened and 463 patients were enrolled in the study and participated in the Run-in Period. Of the 463 enrolled patients, 340 were randomized to study treatment.
Pre-assignment details
During the 7 to 10 day Run-in Period, participants self-administered a single-blind placebo nasal aerosol once daily in the morning and assessed and recorded their seasonal rhinitis symptoms twice daily to determine eligibility for randomization.
Participants by arm
| Arm | Count |
|---|---|
| BDP HFA 320 µg/Day During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning. | 167 |
| Placebo During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning. | 171 |
| Total | 338 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Never received study treatment | 2 | 0 |
| Overall Study | Protocol Violation | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | BDP HFA 320 µg/Day | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 39.3 years STANDARD_DEVIATION 13.4 | 38.0 years STANDARD_DEVIATION 13.3 | 38.6 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 52 Participants | 49 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants | 122 Participants | 237 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 3 participants | 6 participants |
| Race/Ethnicity, Customized Black or African American | 23 participants | 26 participants | 49 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 142 participants | 142 participants | 284 participants |
| Sex: Female, Male Female | 113 Participants | 97 Participants | 210 Participants |
| Sex: Female, Male Male | 54 Participants | 74 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 167 | 10 / 171 |
| serious Total, serious adverse events | 1 / 167 | 0 / 171 |
Outcome results
Primary
Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping). The rTNSS (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 1-15
Population: Intent to treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BDP HFA 320 µg/Day | Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period | -2.0 units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period | -1.0 units on a scale | Standard Error 0.15 |
p-value: <0.00195% CI: [-1.3, -0.5]ANCOVA
Secondary
Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline
The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of 'emotional' utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement.
Time frame: Day 0 (Baseline), Day 15
Population: The RQLQ population, subset of ITT population, included only those participants over the age of 18 years (fluent in English) with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BDP HFA 320 µg/Day | Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | -1.2 units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline | -0.8 units on a scale | Standard Error 0.12 |
p-value: 0.00595% CI: [-0.8, -0.1]ANCOVA
Secondary
Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period
Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities). The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement.
Time frame: Baseline (Days -3 to 0), and Days 1-15
Population: Intent to treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BDP HFA 320 µg/Day | Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period | -1.3 units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period | -0.7 units on a scale | Standard Error 0.12 |
p-value: 0.00295% CI: [-0.9, -0.2]ANCOVA
Secondary
Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The iTNSS (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 1-15
Population: Intent to treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| BDP HFA 320 µg/Day | Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period | -1.7 units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period | -0.8 units on a scale | Standard Error 0.15 |
p-value: <0.00195% CI: [-1.3, -0.5]ANCOVA