Trial Outcomes & Findings for Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth (NCT NCT01520688)

NCT ID: NCT01520688

Last Updated: 2020-11-18

Results Overview

Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma treated with Flovent Discus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: 1 yr
• Results posted on: 2020-11-18

Participant Flow

Participant milestones

Measure	1 Treatment Sequence, FPQ Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR Fluticasone, Budesonide, Beclomethasone: Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid	2 Treatment Sequence, FQP Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort Fluticasone, Beclomethasone, Budesonide: Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID	3 Treatment Sequence, PFQ Period 2 Pulmicort Period 4 Flovent Period 6 QVAR Budesonide, Fluticasone, Beclomethasone: Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID	4-Treatment Sequence, PQF Period 2 Pulmicort Period 4 QVAR Period 6 Flovent Budesonide, Beclomethasone, Fluticasone: Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID	5 Treatment Sequence, QFP Period 2 QVAR Period 4 Flovent Period 6 Pulmicort Beclomethasone, Fluticasone, Budesonide: Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID	6 Treatment Sequence, QPF Period 2 QVAR Period 4 Pulmicort Period 6 Flovent Beclomethasone, Budesonide, Fluticasone: Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID	Enrolled But Not Randomized. These subjects were consented but not randomized.
Overall Study STARTED	4	4	4	5	5	5	5
Overall Study COMPLETED	4	2	4	4	4	5	0
Overall Study NOT COMPLETED	0	2	0	1	1	0	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth

Baseline characteristics by cohort

Measure	All Study Participants n=27 Participants
Age, Continuous	8.4 years STANDARD_DEVIATION 1.57 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	22 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	2 Participants n=5 Participants
Race (NIH/OMB) White	25 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	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 yr

Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma treated with Flovent Discus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.

Outcome measures

Measure	Flovent Discus 100 mcg BID n=27 Participants	Pulmicort Flexhaler 180 mcg BID n=27 Participants
Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.	0.37 mm/wk Interval 0.21 to 0.53	0.21 mm/wk Interval 0.05 to 0.37

SECONDARY outcome

Timeframe: 1 yr

Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma during treatment with Flovent Discus 100 mcg BID or QVAR 80 mcg BID.

Outcome measures

Measure	Flovent Discus 100 mcg BID n=27 Participants	Pulmicort Flexhaler 180 mcg BID n=27 Participants
Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID.	0.37 mm/wk Interval 0.21 to 0.53	0.38 mm/wk Interval 0.22 to 0.54

Adverse Events

Flovent Discus 100 mcg BID

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Pulmicort Flexhaler 180 mcg BID

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

QVAR 80 mcg BID

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Flovent Discus 100 mcg BID n=27 participants at risk	Pulmicort Flexhaler 180 mcg BID n=27 participants at risk	QVAR 80 mcg BID n=27 participants at risk
General disorders Colds/viral illnesses	25.9% 7/27	22.2% 6/27	25.9% 7/27
General disorders Headaches	7.4% 2/27	11.1% 3/27	11.1% 3/27
Respiratory, thoracic and mediastinal disorders Respiratory infections	7.4% 2/27	11.1% 3/27	0.00% 0/27
Immune system disorders Worsening allergies	3.7% 1/27	0.00% 0/27	3.7% 1/27
General disorders Bodily injuries	3.7% 1/27	3.7% 1/27	0.00% 0/27
Immune system disorders Asthma exacerbation	3.7% 1/27	0.00% 0/27	0.00% 0/27
Ear and labyrinth disorders Ear infection	0.00% 0/27	0.00% 0/27	3.7% 1/27
General disorders Sinus infection	0.00% 0/27	0.00% 0/27	3.7% 1/27
Respiratory, thoracic and mediastinal disorders Pneumonia	3.7% 1/27	0.00% 0/27	0.00% 0/27

Additional Information

Deborah Gentile, MD

Allegheny Health Network

Phone: 412-359-4099

Email: dgentile@ahn.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place