Study of an Investigational Nasal Aerosol or Placebo in C... | NCT01783548

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BDP Nasal Aerosol 80 mcg/day	Experimental	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.	Drug: BDP Nasal Aerosol
Placebo Nasal Aerosol	Placebo Comparator	Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BDP Nasal Aerosol	Drug		BDP Nasal Aerosol 80 mcg/day	Beclomethasone dipropionate QNASL®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.	Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6

Secondary Outcomes

Measure	Description	Time Frame
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	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.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Teva Investigational Site 10522		Hot Springs	Arkansas		United States
Teva Investigational Site 10518

PubMed Identifier	Type	Citation	Retractions
26115578	Derived	Berger WE, Jacobs RL, Amar NJ, Tantry SK, Li J, Small CJ. Efficacy and safety of beclomethasone dipropionate nasal aerosol in children with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2015 Aug;115(2):130-6. doi: 10.1016/j.anai.2015.05.012. Epub 2015 Jun 24.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	Placebo Nasal Aerosol

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0008.0± 2.16 BG0018.0± 2.23 BG0028.0± 2.18

Age, Customized

Number

participants

Title

Denominators

Categories

4 to 5 years

Title	Measurements
	BG00062 BG00131 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000175 BG00171 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG000272 BG001145 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG000144 BG00175 BG002

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00033.4± 13.40 BG00133.8± 13.24 BG002

Body Mass Index

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00018.6± 4.22 BG00118.9± 4.33 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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.

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.

Posted

Least Squares Mean

Standard Error

units on a scale

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000296 OG001153

Title

Denominators

Categories

Title	Measurements
	OG000-2.26± 0.12 OG001-1.60± 0.17

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Based on other studies, the standard deviation for the change from baseline over the first 6 weeks of treatment in the average of AM and PM rTNSS is assumed to be 2.0. Using this standard deviation, 450 subjects aged 6 to 11 years (300 on active treatment of BDP and 150 on placebo) provide approximately 90% power to detect a difference of 0.65 in rTNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.	mixed-model for repeated measures (MMRM)	The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.	0.002	a priori statistical significance is <0.05.	LSM treatment difference from placebo	-0.66			2-Sided	95	-1.08	-0.24

Secondary

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

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.

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

Posted

Least Squares Mean

Standard Error

units on a scale

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

ID	Title	Description
OG000	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.
OG001	Placebo Nasal Aerosol

Secondary

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

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.

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.

Posted

Least Squares Mean

Standard Error

units on a scale

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

ID	Title	Description
OG000	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.

Secondary

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

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.

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.

Posted

Least Squares Mean

Standard Error

units on a scale

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

ID	Title	Description
OG000	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			0	362	33	362
EG001	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.			0	185	21	185

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.1)	Systematic Assessment		EG00018 affected362 at risk EG0018 affected185 at risk
Headache	Nervous system disorders	MedDRA (15.1)	Systematic Assessment		EG00016 affected362 at risk EG00114 affected185 at risk

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D010038	Otorhinolaryngologic Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013258	Steroids, Chlorinated