Trial Outcomes & Findings for Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies (NCT NCT01307319)

Last Updated: 2015-02-20

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 was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

715 participants

Primary outcome timeframe

Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

Results posted on

2015-02-20

Participant Flow

A total of 1026 subjects were screened and 906 were enrolled and participated in the Run-in Period. Of the 906 enrolled subjects, 715 were randomized to treatment.

Participant milestones

Participant milestones
Measure	BDP HFA 80 mcg/Day Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.	BDP HFA 160 mcg/Day Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.	Placebo Nasal Aerosol Once Daily Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
Overall Study STARTED	239	242	234
Overall Study Safety Population	239	241	234
Overall Study ITT Population	238	241	234
Overall Study COMPLETED	235	234	227
Overall Study NOT COMPLETED	4	8	7

Reasons for withdrawal

Reasons for withdrawal
Measure	BDP HFA 80 mcg/Day Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.	BDP HFA 160 mcg/Day Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.	Placebo Nasal Aerosol Once Daily Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
Overall Study Adverse Event	2	2	1
Overall Study Lost to Follow-up	1	0	1
Overall Study Protocol Violation	1	1	0
Overall Study Withdrawal by Subject	0	1	2
Overall Study Other	0	4	3

Baseline Characteristics

Study of an Investigational Nasal Aerosol or Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BDP HFA 80 mcg/Day n=239 Participants Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.	BDP HFA 160 mcg/Day n=241 Participants Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.	Placebo Nasal Aerosol Once Daily n=234 Participants Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.	Total n=714 Participants Total of all reporting groups
Age, Continuous	8.9 years STANDARD_DEVIATION 1.73 • n=5 Participants	9.1 years STANDARD_DEVIATION 1.62 • n=7 Participants	9.1 years STANDARD_DEVIATION 1.65 • n=5 Participants	9.0 years STANDARD_DEVIATION 1.67 • n=4 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	116 Participants n=7 Participants	111 Participants n=5 Participants	332 Participants n=4 Participants
Sex: Female, Male Male	134 Participants n=5 Participants	125 Participants n=7 Participants	123 Participants n=5 Participants	382 Participants n=4 Participants
Race/Ethnicity, Customized White	169 participants n=5 Participants	172 participants n=7 Participants	164 participants n=5 Participants	505 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	56 participants n=5 Participants	55 participants n=7 Participants	52 participants n=5 Participants	163 participants n=4 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	12 participants n=4 Participants
Race/Ethnicity, Customized Other	12 participants n=5 Participants	10 participants n=7 Participants	12 participants n=5 Participants	34 participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	40 participants n=5 Participants	53 participants n=7 Participants	45 participants n=5 Participants	138 participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	199 participants n=5 Participants	188 participants n=7 Participants	189 participants n=5 Participants	576 participants n=4 Participants
Body Mass Index	19.0 kg/m^2 STANDARD_DEVIATION 4.15 • n=5 Participants	19.4 kg/m^2 STANDARD_DEVIATION 4.52 • n=7 Participants	19.1 kg/m^2 STANDARD_DEVIATION 4.72 • n=5 Participants	19.1 kg/m^2 STANDARD_DEVIATION 4.46 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

Population: The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment.

Outcome measures

Outcome measures
Measure	BDP HFA 80 mcg/Day n=238 Participants Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.	BDP HFA 160 mcg/Day n=241 Participants Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.	Placebo Nasal Aerosol Once Daily n=234 Participants Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment	-1.9 units on a scale Standard Error 0.14	-2.0 units on a scale Standard Error 0.14	-1.2 units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

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 was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization.

Outcome measures

Outcome measures
Measure	BDP HFA 80 mcg/Day n=238 Participants Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.	BDP HFA 160 mcg/Day n=241 Participants Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.	Placebo Nasal Aerosol Once Daily n=234 Participants Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment	-1.6 units on a scale Standard Error 0.13	-1.7 units on a scale Standard Error 0.13	-1.0 units on a scale Standard Error 0.13

Adverse Events

BDP HFA 80 mcg/Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BDP HFA 160 mcg/Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Nasal Aerosol Once Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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