Trial Outcomes & Findings for Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR) (NCT NCT01783548)

Last Updated: 2015-10-12

Results Overview

Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: * 0 = absent (no sign/symptom present) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

547 participants

Primary outcome timeframe

Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6

Results posted on

2015-10-12

Participant Flow

A total of 770 subjects were screened. The 547 participants were randomly assigned to either BDP nasal aerosol (80 mcg/day) or placebo nasal aerosol in a 2:1 ratio.

Participant milestones

Participant milestones
Measure	BDP Nasal Aerosol 80 mcg/Day BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.	Placebo Nasal Aerosol Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Overall Study STARTED	362	185
Overall Study Full Analysis Set (FAS)	358	184
Overall Study COMPLETED	328	167
Overall Study NOT COMPLETED	34	18

Reasons for withdrawal

Reasons for withdrawal
Measure	BDP Nasal Aerosol 80 mcg/Day BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.	Placebo Nasal Aerosol Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Overall Study Adverse Event	8	4
Overall Study Withdrawal by Subject	11	8
Overall Study Non-compliance	4	0
Overall Study Protocol Violation	2	2
Overall Study Lost to Follow-up	8	3
Overall Study Lack of Efficacy	1	1

Baseline Characteristics

Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BDP Nasal Aerosol 80 mcg/Day n=362 Participants BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.	Placebo Nasal Aerosol n=185 Participants Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.	Total n=547 Participants Total of all reporting groups
Age, Continuous	8.0 years STANDARD_DEVIATION 2.16 • n=5 Participants	8.0 years STANDARD_DEVIATION 2.23 • n=7 Participants	8.0 years STANDARD_DEVIATION 2.18 • n=5 Participants
Age, Customized 4 to 5 years	62 participants n=5 Participants	31 participants n=7 Participants	93 participants n=5 Participants
Age, Customized 6 to 11 years	300 participants n=5 Participants	154 participants n=7 Participants	454 participants n=5 Participants
Sex: Female, Male Female	175 Participants n=5 Participants	71 Participants n=7 Participants	246 Participants n=5 Participants
Sex: Female, Male Male	187 Participants n=5 Participants	114 Participants n=7 Participants	301 Participants n=5 Participants
Race/Ethnicity, Customized White	272 participants n=5 Participants	145 participants n=7 Participants	417 participants n=5 Participants
Race/Ethnicity, Customized Black	65 participants n=5 Participants	25 participants n=7 Participants	90 participants n=5 Participants
Race/Ethnicity, Customized Other	25 participants n=5 Participants	15 participants n=7 Participants	40 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	144 participants n=5 Participants	75 participants n=7 Participants	219 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	217 participants n=5 Participants	110 participants n=7 Participants	327 participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Weight	33.4 kg STANDARD_DEVIATION 13.40 • n=5 Participants	33.8 kg STANDARD_DEVIATION 13.24 • n=7 Participants	33.5 kg STANDARD_DEVIATION 13.34 • n=5 Participants
Body Mass Index	18.6 kg/m^2 STANDARD_DEVIATION 4.22 • n=5 Participants	18.9 kg/m^2 STANDARD_DEVIATION 4.33 • n=7 Participants	18.7 kg/m^2 STANDARD_DEVIATION 4.25 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6

Population: Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment. Subpopulation of study participants aged 6-11 years.

Outcome measures

Outcome measures
Measure	BDP Nasal Aerosol 80 mcg/Day n=296 Participants BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.	Placebo Nasal Aerosol n=153 Participants Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age	-2.26 units on a scale Standard Error 0.12	-1.60 units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6

Population: Full analysis set (FAS). Subpopulation of study participants aged 6-11 years.

Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: * 0 = absent (no sign/symptom present) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period.

Outcome measures

Outcome measures
Measure	BDP Nasal Aerosol 80 mcg/Day n=296 Participants BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.	Placebo Nasal Aerosol n=153 Participants Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age	-1.98 units on a scale Standard Error 0.12	-1.39 units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6

Outcome measures

Outcome measures
Measure	BDP Nasal Aerosol 80 mcg/Day n=358 Participants BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.	Placebo Nasal Aerosol n=184 Participants Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age	-2.32 units on a scale Standard Error 0.11	-1.71 units on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6

Outcome measures

Outcome measures
Measure	BDP Nasal Aerosol 80 mcg/Day n=358 Participants BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.	Placebo Nasal Aerosol n=184 Participants Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age	-2.07 units on a scale Standard Error 0.11	-1.53 units on a scale Standard Error 0.15

Adverse Events

BDP Nasal Aerosol 80 mcg/Day

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo Nasal Aerosol

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BDP Nasal Aerosol 80 mcg/Day n=362 participants at risk BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.	Placebo Nasal Aerosol n=185 participants at risk Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 18/362 • Day 1 to Week 16	4.3% 8/185 • Day 1 to Week 16
Nervous system disorders Headache	4.4% 16/362 • Day 1 to Week 16	7.6% 14/185 • Day 1 to Week 16

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc.

Phone: 215-591-3000

Email: [email protected]

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