CompletedNCT00854360Updated May 22, 2012Results posted

Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR

A Phase 2 interventional study of Beclomethasone dipropionate HFA Nasal Aerosol and Placebo in Seasonal Allergic Rhinitis and Hayfever, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 26 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2012-05-22.

Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 487
Allocation: Randomized
Ages: 12 Years and older
Sex: All

Study summary

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.

Conditions studied

Seasonal Allergic Rhinitis
Hayfever

Browse trials for

Keywords

Seasonal Allergic Rhinitis
Hayfever

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 487 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Male or female patients 12 years of age and older, as of the Screening Visit (SV).
General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study.
A history of SAR to relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV). The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the investigator's judgment is expected to be exposed to the allergen and require treatment throughout the entire study period.
A demonstrated sensitivity to relevant tree/grass pollen known to produce SAR through a standard skin prick test. A positive test is defined as a wheal diameter at least 3 mm larger than the control wheal for the skin prick test. Documentation of a positive result within 12 months prior to Screening Visit (SV) is acceptable.
Other criteria apply

Key Exclusion Criteria:

Participation in any investigational drug study within the 30 days preceding the Screening Visit (SV) or planned participation in another investigational drug study at any time during this study.
History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the SV).
History of a respiratory infection or disorder [including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)] within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
Use of any prohibited concomitant medications within the prescribed (per protocol) time since the last dosing period prior to the Screening Visit (SV) and/or plans for use during the entire treatment duration.
Other criteria apply

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 487 participants (actual)

Study arms

Experimental
BDP HFA 80 µg/day
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily.
Drug: Beclomethasone dipropionate HFA Nasal Aerosol · Drug: Placebo
Experimental
BDP HFA 160 µg/day
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
Drug: Beclomethasone dipropionate HFA Nasal Aerosol
Experimental
BDP HFA 320 µg/day
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
Drug: Beclomethasone dipropionate HFA Nasal Aerosol
Placebo comparator
Placebo
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
Drug: Placebo

Interventions

DrugBeclomethasone dipropionate HFA Nasal Aerosol
Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
Also known as: QNASL(TM)
DrugPlacebo
HFA Vehicle Aerosol

What researchers measure

Primary outcomes

Change From Baseline in Average 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, 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, 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 the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Time frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Secondary outcomes

Change From Baseline in Average 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, itchy nose and nasal congestion) over the 10 minutes prior to the 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 symptom, bothersome but tolerable); 3=severe (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 (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
Change from Baseline in the morning patient-reported instantaneous TNSS. Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 10 minutes (prior to the assessment) in the morning on a scale from 0 (mild symptoms) to 3 (severe symptoms). 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 (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
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 symptom improvement.
Time frame: Baseline and Week 2
Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period
Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes and redness of eyes) for the past 24 hours each morning using the following scale: 0=absent (no sign/symptoms); 1=mild (sign/symptom present, minimal awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptom hard to tolerate, interfere with daily activities or sleeping). The total ocular symptom score (sum of 3 symptom scores) ranges from 0 to 9 (worst symptoms). A negative change from Baseline score indicates symptom improvement.
Time frame: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period
Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes and itching of ears or palate) for the past 24 hours each morning using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities or sleeping). Total non-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 (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Results

Posted May 22, 2012

Participant flow

A total of 685 patients were screened and 635 were enrolled in the study and participated in the Run-in Period. Of the 635 enrolled patients, 487 were randomized to treatment. The study was performed in the spring during tree and grass pollen seasons.

Participant flow — Overall Study
Milestone	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo
Started	118	123	122	124
Intent to treat / safety population	118	123	122	123
Completed	116	120	120	114
Not completed	2	3	2	10
Withdrew: Adverse event	0	1	2	6
Withdrew: Withdrawal by subject	0	0	0	1
Withdrew: Pregnancy	0	1	0	0
Withdrew: Lack of efficacy	2	1	0	0
Withdrew: Other	0	0	0	3

Outcome measures

PrimaryChange From Baseline in Average 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, 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, 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 the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.

Time frame:: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Reported as:: Least squares mean · units on a scale

Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
units on a scale	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo
Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period	-1.88 ± 0.18	-1.87 ± 0.18	-2.22 ± 0.18	-1.59 ± 0.18

Statistical analysis

BDP HFA 80 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.255 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.29 · 95% CI -0.80 to 0.21The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.
BDP HFA 160 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.257 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.29 · 95% CI -0.78 to 0.21The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.
BDP HFA 320 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.013 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.63 · 95% CI -1.13 to -0.13The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.

SecondaryChange From Baseline in Average 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, itchy nose and nasal congestion) over the 10 minutes prior to the 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 symptom, bothersome but tolerable); 3=severe (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 (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Reported as:: Least squares mean · units on a scale

Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period
units on a scale	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo
Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period	-1.77 ± 0.18	-1.71 ± 0.18	-2.10 ± 0.18	-1.50 ± 0.18

Statistical analysis

BDP HFA 80 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.278 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.27 · 95% CI -0.77 to 0.22The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.
BDP HFA 160 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.385 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.22 · 95% CI -0.70 to 0.27The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.
BDP HFA 320 µg/Day vs Placebo · Repeated Measures ANCOVA · p = 0.016 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.60 · 95% CI -1.09 to -0.11The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.

SecondaryChange From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period

Change from Baseline in the morning patient-reported instantaneous TNSS. Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 10 minutes (prior to the assessment) in the morning on a scale from 0 (mild symptoms) to 3 (severe symptoms). 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 (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Reported as:: Least squares mean · units on a scale

Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
units on a scale	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo
Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period	-1.76 ± 0.18	-1.71 ± 0.18	-2.14 ± 0.18	-1.31 ± 0.18

Statistical analysis

BDP HFA 80 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.082 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.45 · 95% CI -0.95 to 0.06The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.
BDP HFA 160 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.114 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.40 · 95% CI -0.90 to 0.10The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.
BDP HFA 320 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.001 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.83 · 95% CI -1.33 to -0.33The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.

SecondaryChange 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 symptom improvement.

Time frame:: Baseline and Week 2
Reported as:: Least squares mean · units on a scale

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
units on a scale	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	-1.30 ± 0.17	-1.33 ± 0.15	-1.62 ± 0.17	-1.22 ± 0.16

Statistical analysis

BDP HFA 80 µg/Day vs Placebo · ANCOVA · p = 0.747 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.07 · 95% CI -0.52 to 0.37Results obtained from ANCOVA with treatment, baseline and center in the model.
BDP HFA 160 µg/Day vs Placebo · ANCOVA · p = 0.605 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.11 · 95% CI -0.53 to 0.31Results obtained from ANCOVA with treatment, baseline and center in the model.
BDP HFA 320 µg/Day vs Placebo · ANCOVA · p = 0.083 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.39 · 95% CI -0.84 to 0.05Results obtained from ANCOVA with treatment, baseline and center in the model.

SecondaryChange From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period

Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes and redness of eyes) for the past 24 hours each morning using the following scale: 0=absent (no sign/symptoms); 1=mild (sign/symptom present, minimal awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptom hard to tolerate, interfere with daily activities or sleeping). The total ocular symptom score (sum of 3 symptom scores) ranges from 0 to 9 (worst symptoms). A negative change from Baseline score indicates symptom improvement.

Time frame:: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Reported as:: Least squares mean · units on a scale

Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period
units on a scale	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo
Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period	-1.16 ± 0.16	-1.11 ± 0.16	-1.46 ± 0.16	-1.17 ± 0.16

Statistical analysis

BDP HFA 80 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.989 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.00 · 95% CI -0.45 to 0.46The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.
BDP HFA 160 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.808 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.06 · 95% CI -0.39 to 0.50The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.
BDP HFA 320 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.195 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.29 · 95% CI -0.74 to 0.15The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.

SecondaryChange From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period

Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes and itching of ears or palate) for the past 24 hours each morning using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities or sleeping). Total non-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 (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Reported as:: Least squares mean · units on a scale

Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period
units on a scale	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo
Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period	-1.55 ± 0.22	-1.49 ± 0.22	-1.91 ± 0.21	-1.51 ± 0.22

Statistical analysis

BDP HFA 80 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.903 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: 0.04 · 95% CI -0.64 to 0.57The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.
BDP HFA 160 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.952 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: 0.02 · 95% CI -0.58 to 0.62The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.
BDP HFA 320 µg/Day vs Placebo · Repeated measures ANCOVA · p = 0.187 (A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.) · Ls mean difference: -0.40 · 95% CI -0.99 to 0.19The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BDP HFA 80 µg/Day	—	0/118 (0%)	6/118 (5.1%)
BDP HFA 160 µg/Day	—	2/123 (1.6%)	3/123 (2.4%)
BDP HFA 320 µg/Day	—	0/122 (0%)	3/122 (2.5%)
Placebo	—	0/123 (0%)	1/123 (0.8%)

Most frequent serious events

Most frequent serious events
Event	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo
AngioedemaSkin and subcutaneous tissue disorders	0/118	1/123	0/122	0/123
Abortion spontaneous incompletePregnancy, puerperium and perinatal conditions	0/118	1/123	0/122	0/123

Most frequent other events

Most frequent other events
Event	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo
EpistaxisRespiratory, thoracic and mediastinal disorders	6/118	3/123	3/122	1/123

Baseline characteristics

Age Continuous
Age Continuous(years)	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo	Total
Mean	37.6 ± 13.86	39.8 ± 15.26	38.5 ± 14.74	38.2 ± 13.95	38.5 ± 14.45

Sex: Female, Male
Sex: Female, Male(Participants)	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo	Total
Female	76	86	81	73	316
Male	42	37	41	50	170

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo	Total
White	92	99	98	97	386
Black	23	18	22	19	82
Asian	2	5	0	6	13
Other	1	1	2	1	5

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo	Total
Hispanic or Latino	14	10	17	15	56
Not Hispanic or Latino	104	113	105	108	430

Region of Enrollment
Region of Enrollment(participants)	BDP HFA 80 µg/Day	BDP HFA 160 µg/Day	BDP HFA 320 µg/Day	Placebo	Total
United States	118	123	122	123	486

Study locations

26 sites

Teva Global Respiratory Research Study Site
Mission Viejo, California 92691, United States
Teva Global Respiratory Research Study Site
San Diego, California 92120, United States
Teva Global Respiratory Research Study Site
San Diego, California 92123, United States
Teva Global Respiratory Research Study Site
Colorado Springs, Colorado 08907, United States
Teva Global Respiratory Research Study Site
Denver, Colorado 08230, United States
Teva Global Respiratory Research Study Site
Gainesville, Georgia 030501, United States
Teva Global Respiratory Research Study Site
Savannah, Georgia 31406, United States
Teva Global Respiratory Research Study Site
Indianapolis, Indiana 46208, United States
Teva Global Respiratory Research Study Site
Overland Park, Kansas 66210, United States
Teva Global Respiratory Research Study Site
Bethesda, Maryland 20814, United States
Teva Global Respiratory Research Study Site
St. Louis, Missouri 63141, United States
Teva Global Respiratory Research Study Site
Brick, New Jersey 08724, United States
Teva Global Respiratory Research Study Site
Raleigh, North Carolina 27607, United States
Teva Global Respiratory Research Study Site
Medford, Oregon 97504, United States
Teva Global Respiratory Research Study Site
Portland, Oregon 97213, United States
Teva Global Respiratory Research Study Site
Blue Bell, Pennsylvania 19422, United States
Teva Global Respiratory Research Study Site
Pittsburgh, Pennsylvania 15241, United States
Teva Global Respiratory Research Study Site
Upland, Pennsylvania 19013, United States
Teva Global Respiratory Research Study Site
Charleston, South Carolina 29407, United States
Teva Global Respiratory Research Study Site
Austin, Texas 78713, United States
Teva Global Respiratory Research Study Site
Dallas, Texas 75231, United States
Teva Global Respiratory Research Study Site
New Braunfels, Texas 78130, United States
Teva Global Respiratory Research Study Site
San Antonio, Texas 78229, United States
Teva Global Respiratory Research Study Site
Draper, Utah 84020, United States
Teva Global Respiratory Research Study Site
Burke, Virginia 22015, United States
Teva Global Respiratory Research Study Site
Richmond, Virginia 23233, United States

References and documents

Publications

Raphael GD, Berger WE, Prenner BM, Finn AF Jr, Kelley L, Tantry SK. Efficacy, safety, and optimal dose selection of beclomethasone dipropionate nasal aerosol for seasonal allergic rhinitis in adolescents and adults. Curr Med Res Opin. 2013 Oct;29(10):1329-40. doi: 10.1185/03007995.2013.821055. Epub 2013 Aug 6. PubMed 23815103 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00854360
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Responsible party: Sponsor
First posted: Mar 3, 2009
Start date: Mar 2009
Primary completion: May 2009
Completion: May 2009
Results posted: May 22, 2012
Last update: May 22, 2012

Study contacts

Sudeesh Tantry, Ph.D.

study chair · Teva Branded Pharmaceutical Products R&D, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rhinitis→

Other studies from this sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Start the discussion