AsthmaNCT01328964
Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
An observational study of Asthma, run by GlaxoSmithKline.
Trial summary
The objective of this study is to compare asthma-related exacerbations (emergency department (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that received either fluticasone propionate 44 mcg (FP44) or budesonide (BUD) or montelukast (MON). Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone propionate, Budesonide and Montelukast
- How many people
- 9,906 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to May 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Claims related to pediatric patients age 4-12 in the database with one or more outpatient pharmacy claims for fluticasone propionate 44 micrograms (FP44) or budesonide (BUD) or montelukast (MON) between January 1, 2000 and June 30, 2008.
Who may be able to join
- ICD-9 code for asthma
- one or more outpatient pharmacy claims for fluticasone propionate 44mg or budesonide between January 1, 2000 and June 30, 2008
- ages 4 to 11 years
Who cannot join
- diagnosis of Cystic Fibrosis
- ≥ 1 Rx claim for any asthma controller in the pre-index period
About this study
The objective of this study is to compare asthma-related exacerbations (emergency department (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that received either fluticasone propionate 44 mcg (FP44) or budesonide (BUD) or montelukast (MON). This retrospective observational cohort analysis utilizes a large managed care database with linked pharmacy and medical claims. Patients with ≥ 1 pharmacy claim FP44 or BUD or MON between January 1, 2000 through June 30, 2008 (4-11 years old at time of index) with ≥ 1 diagnosis for asthma (ICD-9 493.xx) in the pre-index period and continuously eligible to receive healthcare services for 1-year pre-index and at least 30 days post-index. Dose of each inhaled corticosteroid was not known in the database. Follow-up was defined for each patient as the period beginning with the index date and ending with the last date of continuous claims history, switch to another asthma controller medication, or claim for an asthma related event (ED/IP visit or OCS use) post-index, whichever occurred first.
- Conditions
- Asthma
- Being tested
- Fluticasone propionate, Budesonide, Montelukast
- Keywords
- pediatric, asthma, outcomes, inhaled cortcosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionateDrug
Also called Flovent® is a registered trademark of GlaxoSmithKline
fluticasone propionate 44 mcg
BudesonideDrug
Also called Singulair®is a registered trademark of Merck and Company
budesonide
MontelukastDrug
Also called Rhinocort® is a registered trademark of AstraZeneca
montelukast
| Study group | Role | What they receive |
|---|---|---|
| Children Ages 4-11 with asthma | Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy Receives: Drug: Fluticasone propionate; Drug: Budesonide; Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years
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.
Measured: January 1, 2000 to June 30, 2008
Secondary outcomes (2)
Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period
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.
Measured: 12 months prior to January 1, 2000 to June 30, 2008
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years
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.
Measured: 12 months prior to January 1, 2000 to June 30, 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,906 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328964
- Sponsor's protocol ID
- 112608
- Status last verified
- Jun 2017
- First submitted
- 4 Mar 2010
- Last updated
- 6 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
- ClinicalTrials.gov ID
- NCT01328964
- Acronym / sponsor ID
- 112608
- Conditions
- Asthma
- Keywords
- pediatric, asthma, outcomes, inhaled cortcosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,906 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Posted 5 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare asthma-related exacerbations (emergency department (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that received either fluticasone propionate 44 mcg (FP44) or budesonide (BUD) or montelukast (MON). This retrospective observational cohort analysis utilizes a large managed care database with linked pharmacy and medical claims. Patients with ≥ 1 pharmacy claim FP44 or BUD or MON between January 1, 2000 through June 30, 2008 (4-11 years old at time of index) with ≥ 1 diagnosis for asthma (ICD-9 493.xx) in the pre-index period and continuously eligible to receive healthcare services for 1-year pre-index and at least 30 days post-index. Dose of each inhaled corticosteroid was not known in the database. Follow-up was defined for each patient as the period beginning with the index date and ending with the last date of continuous claims history, switch to another asthma controller medication, or claim for an asthma related event (ED/IP visit or OCS use) post-index, whichever occurred first.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children Ages 4-11 with asthma | – | Drug: Fluticasone propionate, Drug: Budesonide, Drug: MontelukastChildren ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Claims related to pediatric patients age 4-12 in the database with one or more outpatient pharmacy claims for fluticasone propionate 44 micrograms (FP44) or budesonide (BUD) or montelukast (MON) between January 1, 2000 and June 30, 2008.
Key inclusion criteria (3 listed)
- ICD-9 code for asthma
- one or more outpatient pharmacy claims for fluticasone propionate 44mg or budesonide between January 1, 2000 and June 30, 2008
- ages 4 to 11 years
Key exclusion criteria (2 listed)
- diagnosis of Cystic Fibrosis
- ≥ 1 Rx claim for any asthma controller in the pre-index period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone propionateAlso: Flovent® is a registered trademark of GlaxoSmithKlinefluticasone propionate 44 mcg | Drug | Children Ages 4-11 with asthma |
| BudesonideAlso: Singulair®is a registered trademark of Merck and Companybudesonide | Drug | Children Ages 4-11 with asthma |
| MontelukastAlso: Rhinocort® is a registered trademark of AstraZenecamontelukast | Drug | Children Ages 4-11 with asthma |
Primary outcome
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years
Time frame: 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.
2 secondary outcomes
Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period
Time frame: 12 months prior to January 1, 2000 to June 30, 2008
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years
Time frame: 12 months prior to January 1, 2000 to June 30, 2008
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years (time frame: January 1, 2000 to June 30, 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.