AsthmaNCT01332344
Outcomes in Patients Taking Fluticasone Propionate/Salmeterol Combination or Other Inhaled Corticosteroids
An observational study of Asthma, run by GlaxoSmithKline.
Trial summary
The objective of this study is to compare healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg ("FSC 100/50") or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone propionate/salmeterol combination and Inhaled corticosteroids
- How many people
- 5,180 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study intends to identify subjects with asthma treated with inhaled corticosteroids
Who may be able to join
- Subjects with asthma as determined by ICD-9 codes and asthma drug use
- at least 12 years of age
- treated with inhaled corticosteroids
Who cannot join
- Subjects with COPD or treatment for COPD
About this study
Official title: Comparison of Healthcare Utilization and Costs in Patients With Asthma Who Fluticasone/Salmeterol Inhalation Powder Versus Other Inhaled Corticosteroid(s) in Typical Clinical Practice Using Health Insurance Claims Data.
The objective of this study is to compare healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg ("FSC 100/50") or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care database.
- Conditions
- Asthma
- Being tested
- Fluticasone propionate/salmeterol combination, Inhaled corticosteroids
- Keywords
- fluticasone propionate/salmeterol combination, Asthma, inhaled corticosteroids, outcomes
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionate/salmeterol combinationDrug
Asthma subjects newly prescribed fluticasone propionate/salmeterol combination
Inhaled corticosteroidsDrug
asthma subjects newly prescribed inhaled corticosteroids in clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Asthma patients treated with inhaled corticosteroids | Asthma subjects newly prescribed inhaled corticosteriods Receives: Drug: Fluticasone propionate/salmeterol combination; Drug: Inhaled corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the difference in asthma related exacerbations
Asthma related exaceberation is defined as any asthma related emergency department visit, or inpatient visit or oral corticosteroid dispensing.
Measured: 90 days post index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 5,180 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
- NCT01332344
- Sponsor's protocol ID
- 112604
- Status last verified
- Jun 2017
- First submitted
- 4 Mar 2010
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Healthcare Utilization and Costs in Patients With Asthma Who Fluticasone/Salmeterol Inhalation Powder Versus Other Inhaled Corticosteroid(s) in Typical Clinical Practice Using Health Insurance Claims Data.
- ClinicalTrials.gov ID
- NCT01332344
- Acronym / sponsor ID
- 112604
- Conditions
- Asthma
- Keywords
- fluticasone propionate/salmeterol combination, Asthma, inhaled corticosteroids, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,180 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Not posted in the source record
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 healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg ("FSC 100/50") or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care database.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma patients treated with inhaled corticosteroids | – | Drug: Fluticasone propionate/salmeterol combination, Drug: Inhaled corticosteroidsAsthma subjects newly prescribed inhaled corticosteriods |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study intends to identify subjects with asthma treated with inhaled corticosteroids
Key inclusion criteria (3 listed)
- Subjects with asthma as determined by ICD-9 codes and asthma drug use
- at least 12 years of age
- treated with inhaled corticosteroids
Key exclusion criteria (1 listed)
- Subjects with COPD or treatment for COPD
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 propionate/salmeterol combinationAsthma subjects newly prescribed fluticasone propionate/salmeterol combination | Drug | Asthma patients treated with inhaled corticosteroids |
| Inhaled corticosteroidsasthma subjects newly prescribed inhaled corticosteroids in clinical practice | Drug | Asthma patients treated with inhaled corticosteroids |
Primary outcome
To assess the difference in asthma related exacerbations
Time frame: 90 days post index
Asthma related exaceberation is defined as any asthma related emergency department visit, or inpatient visit or oral corticosteroid dispensing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
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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 1 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 2 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the difference in asthma related exacerbations (time frame: 90 days post index). 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 2 Jun 2017.