Trial Outcomes & Findings for Flunisolide HFA in Children With Small Airway Disease (NCT NCT02404103)

NCT ID: NCT02404103

Last Updated: 2017-12-14

Results Overview

the most used outcome in respiratory studies

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: Before and after treatment at baseline and six week followup
• Results posted on: 2017-12-14

Participant Flow

Participant milestones

Measure	Flunisolide 160 mcg Per Day Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 320 mcg Per Day Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA
Overall Study STARTED	14	12
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Flunisolide 160 mcg Per Day Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 320 mcg Per Day Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Flunisolide HFA in Children With Small Airway Disease

Baseline characteristics by cohort

Measure	Flunisolide 160 mcg Per Day n=10 Participants Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 320 mcg Per Day n=9 Participants Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA	Total n=19 Participants Total of all reporting groups
Age, Continuous	10.1 years STANDARD_DEVIATION 3.8 • n=93 Participants	11.1 years STANDARD_DEVIATION 2.9 • n=4 Participants	10.5 years STANDARD_DEVIATION 3.2 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	10 participants n=93 Participants	9 participants n=4 Participants	19 participants n=27 Participants

PRIMARY outcome

Timeframe: Before and after treatment at baseline and six week followup

Population: Those subjects that completed the study protocol.

the most used outcome in respiratory studies

Outcome measures

Measure	Flunisolide 160 mcg Per Day Pretreatment - Baseline n=10 Participants Baseline value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 320 mcg Per Day Pretreatment - Baseline n=9 Participants Baseline for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 160 mcg Per Day Posttreatment - 6 Wks n=10 Participants After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period	Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks n=9 Participants After 6 week valeus for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA
Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide	80.4 % of predicted Standard Deviation 10.8	78.7 % of predicted Standard Deviation 9.0	85.0 % of predicted Standard Deviation 10.3	77.0 % of predicted Standard Deviation 7.6

PRIMARY outcome

Timeframe: Baseline and six week followup

Population: Those subjects that completed the study protocol.

A composite measure of small airway dysfunction. A reduction in IOS scores indicate an improvement.

Outcome measures

Measure	Flunisolide 160 mcg Per Day Pretreatment - Baseline n=10 Participants Baseline value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 320 mcg Per Day Pretreatment - Baseline n=9 Participants Baseline for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 160 mcg Per Day Posttreatment - 6 Wks n=10 Participants After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period	Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks n=9 Participants After 6 week valeus for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA
Impulse Oscillometry (IOS) Area of Reactance (AX) After Flunisolide Treatment	17.4 cmH2O/L Standard Deviation 12.3	13.9 cmH2O/L Standard Deviation 16.6	18.5 cmH2O/L Standard Deviation 9.6	14.9 cmH2O/L Standard Deviation 13.5

PRIMARY outcome

Timeframe: baseline and six week followup

Population: Those subjects that completed the study protocol.

Indirectly assess small airway function.

Outcome measures

Measure	Flunisolide 160 mcg Per Day Pretreatment - Baseline n=10 Participants Baseline value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 320 mcg Per Day Pretreatment - Baseline n=9 Participants Baseline for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 160 mcg Per Day Posttreatment - 6 Wks n=10 Participants After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period	Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks n=9 Participants After 6 week valeus for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA
Spirometry Forced Expiratory Flow 25-75% (FEF 25-75%)	60.3 % of predicted Standard Deviation 20.0	61.5 % of predicted Standard Deviation 13.7	57.7 % of predicted Standard Deviation 12.1	65.2 % of predicted Standard Deviation 18.9

PRIMARY outcome

Timeframe: initial visit and six week followup

Population: Only data for subjects who completed study are presented.

Resistance of the respiratory system at 5 Hz is a measure of total airway resistance. Elevated value is indicative of respiratory dysfunction.

Outcome measures

Measure	Flunisolide 160 mcg Per Day Pretreatment - Baseline n=10 Participants Baseline value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 320 mcg Per Day Pretreatment - Baseline n=9 Participants Baseline for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 160 mcg Per Day Posttreatment - 6 Wks n=10 Participants After 6 weeks treatment value for Patients who received inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period	Flunisolide 320 mcg Per Day Posttreatment - 6 Weeks n=9 Participants After 6 week valeus for patients who received inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA
Impulse Oscillometry (IOS) Resistance 5 (R5)	6.5 cmH2O(L/s) Standard Deviation 2.0	5.8 cmH2O(L/s) Standard Deviation 2.3	7.0 cmH2O(L/s) Standard Deviation 1.4	6.0 cmH2O(L/s) Standard Deviation 1.8

Adverse Events

Flunisolide 160 mcg Per Day

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Flunisolide 320 mcg Per Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Flunisolide 160 mcg Per Day n=10 participants at risk Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period Flunisolide HFA	Flunisolide 320 mcg Per Day n=9 participants at risk Patients will receive inhaled Flunisolide HFA 160 mcg twice per day for a total of 320 mcg per day over the 6 week study period Flunisolide HFA
Renal and urinary disorders Urinary tract infection	10.0% 1/10 • Number of events 1 • up to 6 weeks	0.00% 0/9 • up to 6 weeks

Other adverse events

Adverse event data not reported

Additional Information

Nemr Eid, MD

University Louisville

Phone: 502-852-3772

Email: n.eid@louisville.edu

Results disclosure agreements

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