Trial Outcomes & Findings for Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population (NCT NCT01328964)

Results Overview

The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.

Recruitment status

COMPLETED

Target enrollment

9906 participants

Primary outcome timeframe

January 1, 2000 to June 30, 2008

Results posted on

2017-07-06

Participant Flow

This was a retrospective observational study utilizing a large managed care database with linked pharmacy and medical claims. The dose of each inhaled corticosteroid was not known in the database.

Participant milestones

Participant milestones
Measure	Fluticasone Propionate Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma	Budesonide Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma	Montelukast Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
Overall Study STARTED	2212	3270	4424
Overall Study COMPLETED	2212	3270	4424
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluticasone Propionate n=2212 Participants Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma	Budesonide n=3270 Participants Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma	Montelukast n=4424 Participants Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma	Total n=9906 Participants Total of all reporting groups
Age, Continuous	7.18 Years STANDARD_DEVIATION 2.20 • n=5 Participants	7.30 Years STANDARD_DEVIATION 2.27 • n=7 Participants	7.21 Years STANDARD_DEVIATION 2.23 • n=5 Participants	7.23 Years STANDARD_DEVIATION 2.23 • n=4 Participants
Sex: Female, Male Female	897 Participants n=5 Participants	1267 Participants n=7 Participants	1797 Participants n=5 Participants	3961 Participants n=4 Participants
Sex: Female, Male Male	1315 Participants n=5 Participants	2003 Participants n=7 Participants	2627 Participants n=5 Participants	5945 Participants n=4 Participants

PRIMARY outcome

Timeframe: January 1, 2000 to June 30, 2008

Population: Members of the IMS Life Link Health Plans Claims Database (containing data from \>=90 managed healthcare plans, encompassing \>=60 million lives) who had \>=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.

The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate n=1635 Participants Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma	Budesonide n=3270 Participants Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years Hospitalizations	0.89 asthma events per 100 person years	0.61 asthma events per 100 person years
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years Emergency Department Visits	3.35 asthma events per 100 person years	5.30 asthma events per 100 person years
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years Hospitalizations or Emergency Department Visits	4.17 asthma events per 100 person years	5.85 asthma events per 100 person years

SECONDARY outcome

Timeframe: 12 months prior to January 1, 2000 to June 30, 2008

Population: Members of the IMS Life Link Health Plans Claims Database (containing data from \>=90 managed healthcare plans, encompassing \>=60 million lives) who had \>=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.

The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate n=1635 Participants Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma	Budesonide n=3270 Participants Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period Monthly Medical Costs	25 United States dollars Standard Deviation 126	27 United States dollars Standard Deviation 166
Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period Monthly Pharmacy Costs	20 United States dollars Standard Deviation 40	32 United States dollars Standard Deviation 71
Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period Monthly Total Costs	45 United States dollars Standard Deviation 136	59 United States dollars Standard Deviation 186

SECONDARY outcome

Timeframe: 12 months prior to January 1, 2000 to June 30, 2008

Population: Members of the IMS Life Link Health Plans Claims Database (containing data from \>=90 managed healthcare plans, encompassing \>=60 million lives) who had \>=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.

The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate n=2212 Participants Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma	Budesonide n=4424 Participants Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years Hospitalizations	0.71 Asthma related events per100 person year	0.62 Asthma related events per100 person year
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years Emergency Department Visits	3.40 Asthma related events per100 person year	4.76 Asthma related events per100 person year
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years Hospitalizations or Emergency Department Visits	4.07 Asthma related events per100 person year	5.29 Asthma related events per100 person year

SECONDARY outcome

Timeframe: 12 months prior to January 1, 2000 to June 30, 2008

Population: Members of the IMS Life Link Health Plans Claims Database (containing data from \>=90 managed healthcare plans, encompassing \>=60 million lives) who had \>=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.

The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate n=2212 Participants Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma	Budesonide n=4424 Participants Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period Monthly Medical Costs	26 United States dollars Standard Deviation 165	27 United States dollars Standard Deviation 176
Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period Monthly Pharmacy Costs	21 United States dollars Standard Deviation 87	48 United States dollars Standard Deviation 75
Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period Monthly Total Costs	48 United States dollars Standard Deviation 190	75 United States dollars Standard Deviation 197

Adverse Events

Fluticasone Propionate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Budesonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Montelukast

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

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER