Trial · NCT01328964
Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
NCT01328964, Completed, GlaxoSmithKline; results first posted 2011-05-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population. Trials, record NCT01328964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01328964
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
- NCT number
- NCT01328964
- Status
- Completed
- Enrollment
- 9,906 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- Fluticasone propionate, Budesonide, Montelukast
- First posted
- 2011-04-05
- Last updated
- 2017-07-06
- Results first posted
- 2011-05-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | January 1, 2000 to June 30, 2008 | 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. |
| Secondary | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | 12 months prior to January 1, 2000 to June 30, 2008 | 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. |
| Secondary | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | 12 months prior to January 1, 2000 to June 30, 2008 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | January 1, 2000 to June 30, 2008 | 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. | asthma events per 100 person years | NUMBER |
| SECONDARY | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | 12 months prior to January 1, 2000 to June 30, 2008 | 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. | United States dollars | MEAN |
| SECONDARY | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | 12 months prior to January 1, 2000 to June 30, 2008 | 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. | Asthma related events per100 person year | NUMBER |
| SECONDARY | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | 12 months prior to January 1, 2000 to June 30, 2008 | 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. | United States dollars | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Fluticasone Propionate | Hospitalizations | 0.89 | 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 | Budesonide | Hospitalizations | 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 | Fluticasone Propionate | Emergency Department Visits | 3.35 | 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 | Budesonide | Emergency Department Visits | 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 | Fluticasone Propionate | Hospitalizations or Emergency Department Visits | 4.17 | 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 | Budesonide | Hospitalizations or Emergency Department Visits | 5.85 | asthma events per 100 person years | |
| Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Fluticasone Propionate | Monthly Medical Costs | 25 | Standard Deviation 126 | United States dollars |
| Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Budesonide | Monthly Medical Costs | 27 | Standard Deviation 166 | United States dollars |
| Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Fluticasone Propionate | Monthly Pharmacy Costs | 20 | Standard Deviation 40 | United States dollars |
| Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Budesonide | Monthly Pharmacy Costs | 32 | Standard Deviation 71 | United States dollars |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluticasone Propionate | 2,212 | |
| Overall Study | STARTED | Budesonide | 3,270 | |
| Overall Study | STARTED | Montelukast | 4,424 | |
| Overall Study | COMPLETED | Fluticasone Propionate | 2,212 | |
| Overall Study | COMPLETED | Budesonide | 3,270 | |
| Overall Study | COMPLETED | Montelukast | 4,424 | |
| Overall Study | NOT COMPLETED | Fluticasone Propionate | 0 | |
| Overall Study | NOT COMPLETED | Budesonide | 0 | |
| Overall Study | NOT COMPLETED | Montelukast | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluticasone Propionate | ||
| Total, all-cause mortality | Budesonide | ||
| Total, all-cause mortality | Montelukast | ||
| Total, other adverse events | Fluticasone Propionate | 0 | 0 |
| Total, other adverse events | Budesonide | 0 | 0 |
| Total, other adverse events | Montelukast | 0 | 0 |
| Total, serious adverse events | Fluticasone Propionate | 0 | 0 |
| Total, serious adverse events | Budesonide | 0 | 0 |
| Total, serious adverse events | Montelukast | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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