Trial Outcomes & Findings for Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis (NCT NCT01550471)
NCT ID: NCT01550471
Last Updated: 2020-11-04
Results Overview
To evaulate the effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID on- short-term lower leg growth as measured by knemometry in children with mild asthma and allergic rhinitis.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
1 yr
Results posted on
2020-11-04
Participant Flow
Participant milestones
| Measure |
A and O, Then Q and B, Then P and P
Treatment Order: Alvesco and Omnaris; QVAR and Beconase; Placebo and Placebo
|
A and O, Then P and P, Then Q and B
Treatment Order: Alvesco and Omnaris; Placebo and Placebo; QVAR and Beconase
|
Q and B, Then A and O, Then P and P
Treatment Order: QVAR and Beconase; Alvesco and Omnaris; Placebo and Placebo
|
Q and B, Then P and P, Then A and O
Treatment Order: Qvar and Beconase; Placebo and Placebo; Alvesco and Omnaris
|
P and P, Then A and O, Then Q and B
Treatment Order: Placebo and Placebo; Alvesco and Omnaris; Qvar and Beconase
|
P and P, Then Q and B, Then A and O
Treatment Order: Placebo and Placebo; Qvar and Beconase; Alvesco and Omnaris
|
|---|---|---|---|---|---|---|
|
Second Treatment Period (3 Weeks)
COMPLETED
|
3
|
4
|
3
|
4
|
4
|
4
|
|
Second Treatment Period (3 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (3 Weeks)
STARTED
|
3
|
4
|
3
|
4
|
4
|
4
|
|
Run-In Period (3 Weeks)
COMPLETED
|
3
|
4
|
3
|
4
|
4
|
4
|
|
Run-In Period (3 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Treatment Period (3 Weeks)
STARTED
|
3
|
4
|
3
|
4
|
4
|
4
|
|
First Treatment Period (3 Weeks)
COMPLETED
|
3
|
4
|
3
|
4
|
4
|
4
|
|
First Treatment Period (3 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Wash Out Period (3 Weeks)
STARTED
|
3
|
4
|
3
|
4
|
4
|
4
|
|
First Wash Out Period (3 Weeks)
COMPLETED
|
3
|
4
|
3
|
4
|
4
|
4
|
|
First Wash Out Period (3 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Treatment Period (3 Weeks)
STARTED
|
3
|
4
|
3
|
4
|
4
|
4
|
|
Second Wash Out Period (3 Weeks)
STARTED
|
3
|
4
|
3
|
4
|
4
|
4
|
|
Second Wash Out Period (3 Weeks)
COMPLETED
|
3
|
4
|
3
|
4
|
4
|
3
|
|
Second Wash Out Period (3 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Third Treatment Period (3 Weeks)
STARTED
|
3
|
4
|
3
|
4
|
4
|
3
|
|
Third Treatment Period (3 Weeks)
COMPLETED
|
3
|
4
|
3
|
4
|
4
|
3
|
|
Third Treatment Period (3 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Wash Out Period (3 Weeks)
STARTED
|
3
|
4
|
3
|
4
|
4
|
3
|
|
Third Wash Out Period (3 Weeks)
COMPLETED
|
3
|
4
|
3
|
4
|
4
|
3
|
|
Third Wash Out Period (3 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
All Study Participants
n=22 Participants
|
|---|---|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yrTo evaulate the effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID on- short-term lower leg growth as measured by knemometry in children with mild asthma and allergic rhinitis.
Outcome measures
| Measure |
Alvesco and Omnaris
n=21 Participants
|
Beconase and QVAR
n=22 Participants
|
|---|---|---|
|
The Effect of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Beconase AQ Nasal Spray & QVAR Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.
|
0.23 mm/wk
Interval 0.04 to 0.41
|
0.33 mm/wk
Interval 0.14 to 0.51
|
SECONDARY outcome
Timeframe: 1 yrTo evaluate growth suppressive effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID as compared to Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID on short-term lower leg growth velocity as measured by knemometry in children with mild asthma and allergic rhinitis.
Outcome measures
| Measure |
Alvesco and Omnaris
n=21 Participants
|
Beconase and QVAR
n=22 Participants
|
|---|---|---|
|
The Effects of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Placebo Nasal Spray & Placebo Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.
|
0.23 mm/wk
Interval 0.04 to 0.41
|
0.51 mm/wk
Interval 0.32 to 0.7
|
Adverse Events
Alvesco and Omnaris
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Qvar and Beconase
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo and Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alvesco and Omnaris
n=21 participants at risk
|
Qvar and Beconase
n=22 participants at risk
|
Placebo and Placebo
n=22 participants at risk
|
|---|---|---|---|
|
General disorders
Headaches/migraine
|
23.8%
5/21
|
18.2%
4/22
|
22.7%
5/22
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infections
|
19.0%
4/21
|
22.7%
5/22
|
18.2%
4/22
|
|
General disorders
Sinus infection
|
4.8%
1/21
|
4.5%
1/22
|
9.1%
2/22
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
4.8%
1/21
|
4.5%
1/22
|
4.5%
1/22
|
|
General disorders
Foot pain during sports
|
0.00%
0/21
|
4.5%
1/22
|
4.5%
1/22
|
|
Eye disorders
Swollen eyelid and adenopathy
|
4.8%
1/21
|
0.00%
0/22
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Sprained ankle
|
0.00%
0/21
|
0.00%
0/22
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/21
|
0.00%
0/22
|
4.5%
1/22
|
|
Gastrointestinal disorders
Viral gastroenteritis
|
4.8%
1/21
|
0.00%
0/22
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Impetigo
|
0.00%
0/21
|
4.5%
1/22
|
0.00%
0/22
|
|
Ear and labyrinth disorders
Bilateral otitis media
|
4.8%
1/21
|
0.00%
0/22
|
0.00%
0/22
|
|
General disorders
Mouth pain
|
0.00%
0/21
|
0.00%
0/22
|
4.5%
1/22
|
Additional Information
Deborah Gentile, Principal Investigator
Allegheny Health Network
Phone: 412-359-4099
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place