Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR (NCT NCT00854360)
NCT ID: NCT00854360
Last Updated: 2012-05-22
Results Overview
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.
COMPLETED
PHASE2
487 participants
Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
2012-05-22
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.
During the 7 - 21 day Run-in Period, patients 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.
Participant milestones
| Measure |
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) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) and two actuations of placebo HFA once daily.
|
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.
|
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.
|
Placebo
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
118
|
123
|
122
|
124
|
|
Overall Study
Intent to Treat / Safety Population
|
118
|
123
|
122
|
123
|
|
Overall Study
COMPLETED
|
116
|
120
|
120
|
114
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
2
|
10
|
Reasons for withdrawal
| Measure |
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) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) and two actuations of placebo HFA once daily.
|
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.
|
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.
|
Placebo
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR
Baseline characteristics by cohort
| Measure |
BDP HFA 80 µg/Day
n=118 Participants
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
|
BDP HFA 160 µg/Day
n=123 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
|
BDP HFA 320 µg/Day
n=122 Participants
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=123 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
Total
n=486 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
37.6 years
STANDARD_DEVIATION 13.86 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 15.26 • n=7 Participants
|
38.5 years
STANDARD_DEVIATION 14.74 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 13.95 • n=4 Participants
|
38.5 years
STANDARD_DEVIATION 14.45 • n=21 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
316 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
170 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
92 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
386 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
15 participants
n=4 Participants
|
56 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
104 participants
n=5 Participants
|
113 participants
n=7 Participants
|
105 participants
n=5 Participants
|
108 participants
n=4 Participants
|
430 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
118 participants
n=5 Participants
|
123 participants
n=7 Participants
|
122 participants
n=5 Participants
|
123 participants
n=4 Participants
|
486 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)Population: The Intent-to-treat population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.
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.
Outcome measures
| Measure |
BDP HFA 80 µg/Day
n=118 Participants
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
|
BDP HFA 160 µg/Day
n=123 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
|
BDP HFA 320 µg/Day
n=122 Participants
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=123 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
|
-1.88 units on a scale
Standard Error 0.18
|
-1.87 units on a scale
Standard Error 0.18
|
-2.22 units on a scale
Standard Error 0.18
|
-1.59 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)Population: Intent to treat population.
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.
Outcome measures
| Measure |
BDP HFA 80 µg/Day
n=118 Participants
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
|
BDP HFA 160 µg/Day
n=123 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
|
BDP HFA 320 µg/Day
n=122 Participants
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=123 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period
|
-1.77 units on a scale
Standard Error 0.18
|
-1.71 units on a scale
Standard Error 0.18
|
-2.10 units on a scale
Standard Error 0.18
|
-1.50 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)Population: Intent to treat population.
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.
Outcome measures
| Measure |
BDP HFA 80 µg/Day
n=118 Participants
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
|
BDP HFA 160 µg/Day
n=123 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
|
BDP HFA 320 µg/Day
n=122 Participants
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=123 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
|
-1.76 units on a scale
Standard Error 0.18
|
-1.71 units on a scale
Standard Error 0.18
|
-2.14 units on a scale
Standard Error 0.18
|
-1.31 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater.
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.
Outcome measures
| Measure |
BDP HFA 80 µg/Day
n=68 Participants
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
|
BDP HFA 160 µg/Day
n=83 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
|
BDP HFA 320 µg/Day
n=69 Participants
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=77 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
|
-1.30 units on a scale
Standard Error 0.17
|
-1.33 units on a scale
Standard Error 0.15
|
-1.62 units on a scale
Standard Error 0.17
|
-1.22 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)Population: The ocular population included only those participants with adequate ocular symptoms during the Run-in Period as defined by a mean daily 24-hour reflective score of 4 or greater for the 24-hour reflective ocular symptom score, over the last 7 days of the Run-in 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.
Outcome measures
| Measure |
BDP HFA 80 µg/Day
n=95 Participants
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
|
BDP HFA 160 µg/Day
n=102 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
|
BDP HFA 320 µg/Day
n=101 Participants
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=100 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period
|
-1.16 units on a scale
Standard Error 0.16
|
-1.11 units on a scale
Standard Error 0.16
|
-1.46 units on a scale
Standard Error 0.16
|
-1.17 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)Population: The non-nasal population included only those participants with adequate non-nasal symptoms during the Run-in Period as defined by a mean daily 24-hour reflective score of 6 or greater for the 24-hour reflective non-nasal symptom score, over the last 7 days of the Run-in 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.
Outcome measures
| Measure |
BDP HFA 80 µg/Day
n=92 Participants
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
|
BDP HFA 160 µg/Day
n=94 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
|
BDP HFA 320 µg/Day
n=97 Participants
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=97 Participants
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|---|---|
|
Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period
|
-1.55 units on a scale
Standard Error 0.22
|
-1.49 units on a scale
Standard Error 0.22
|
-1.91 units on a scale
Standard Error 0.21
|
-1.51 units on a scale
Standard Error 0.22
|
Adverse Events
BDP HFA 80 µg/Day
BDP HFA 160 µg/Day
BDP HFA 320 µg/Day
Placebo
Serious adverse events
| Measure |
BDP HFA 80 µg/Day
n=118 participants at risk
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
|
BDP HFA 160 µg/Day
n=123 participants at risk
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
|
BDP HFA 320 µg/Day
n=122 participants at risk
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=123 participants at risk
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/118
|
0.81%
1/123
|
0.00%
0/122
|
0.00%
0/123
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/118
|
0.81%
1/123
|
0.00%
0/122
|
0.00%
0/123
|
Other adverse events
| Measure |
BDP HFA 80 µg/Day
n=118 participants at risk
During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
|
BDP HFA 160 µg/Day
n=123 participants at risk
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
|
BDP HFA 320 µg/Day
n=122 participants at risk
During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=123 participants at risk
During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
6/118
|
2.4%
3/123
|
2.5%
3/122
|
0.81%
1/123
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
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