Trial Outcomes & Findings for Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis) (NCT NCT01134705)
NCT ID: NCT01134705
Last Updated: 2012-05-23
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, 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.
COMPLETED
PHASE3
474 participants
Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)
2012-05-23
Participant Flow
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.
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.
Participant milestones
| Measure |
BDP HFA 320 µg/Day
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily.
|
Placebo
During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
236
|
238
|
|
Overall Study
Intent to Treat Population
|
232
|
234
|
|
Overall Study
COMPLETED
|
221
|
216
|
|
Overall Study
NOT COMPLETED
|
15
|
22
|
Reasons for withdrawal
| Measure |
BDP HFA 320 µg/Day
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily.
|
Placebo
During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Other
|
1
|
6
|
Baseline Characteristics
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)
Baseline characteristics by cohort
| Measure |
BDP HFA 320 µg/Day
n=232 Participants
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=234 Participants
During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
Total
n=466 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
36.8 years
STANDARD_DEVIATION 14.5 • n=99 Participants
|
37.2 years
STANDARD_DEVIATION 13.7 • n=107 Participants
|
37.0 years
STANDARD_DEVIATION 14.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=99 Participants
|
161 Participants
n=107 Participants
|
319 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
186 participants
n=99 Participants
|
185 participants
n=107 Participants
|
371 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
6 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
26 participants
n=99 Participants
|
30 participants
n=107 Participants
|
56 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
206 participants
n=99 Participants
|
204 participants
n=107 Participants
|
410 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
232 participants
n=99 Participants
|
234 participants
n=107 Participants
|
466 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
BDP HFA 320 µg/Day
n=232 Participants
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=234 Participants
During the 6-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 Six-week Treatment Period
|
-2.5 units on a scale
Standard Error 0.14
|
-1.6 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline (Days -3 to 0) and Days 1-43 (6-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 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.
Outcome measures
| Measure |
BDP HFA 320 µg/Day
n=232 Participants
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=234 Participants
During the 6-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 Six-week Treatment Period
|
-2.1 units on a scale
Standard Error 0.13
|
-1.4 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: 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.
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.
Outcome measures
| Measure |
BDP HFA 320 µg/Day
n=132 Participants
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=125 Participants
During the 6-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)
|
-1.5 units on a scale
Standard Error 0.14
|
-0.9 units on a scale
Standard Error 0.14
|
Adverse Events
BDP HFA 320 µg/Day
Placebo
Serious adverse events
| Measure |
BDP HFA 320 µg/Day
n=236 participants at risk
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=238 participants at risk
During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.42%
1/236
|
0.00%
0/238
|
Other adverse events
| Measure |
BDP HFA 320 µg/Day
n=236 participants at risk
During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
|
Placebo
n=238 participants at risk
During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
5.9%
14/236
|
5.0%
12/238
|
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