AsthmaNCT01431924
Observed Outcomes Associated With Fluticasone Propionate/Salmeterol Xinafoate or Inhaled Corticosteroids in Asthma Patients
An observational study of Asthma, run by GlaxoSmithKline.
Trial summary
This is an observational retrospective analysis of linked pharmacy and medical claims data from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Higher-dose inhaled corticosteroids and Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combination
- How many people
- 7,779 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Jan 2012
- 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: Asthma subjects identified from the IMS Health/Pharmetrics database, which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median). Subjects will be identified using asthma ICD-9 codes (493.xx) and use of asthma medications. Subjects will be between the ages of 12 and 65 without comorbid chronic obstruction pulmonary disease. To be included in the analysis, subjects will need a dispensing history of either fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or 100mcg/50mcg combinations or fluticasone propionate 110 mcg or 220 mcg.
Who may be able to join
- One or more medical claims with a diagnosis (primary or secondary) of asthma (ICD-9-CM 493.XX) during study period;
- One or more outpatient pharmacy claims during the study for one or more of the following "study medications":
- Fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or 100mcg/50mcg combinations
- Fluticasone propionate 110 mcg or 220 mcg
- One or more asthma exacerbations (asthma-related hospitalization or emergency department visit, oral corticosteriod prescription drug claim, or a combination of any of the above events) during the 12 months prior to the index date ("pre-index period") or
- Five or more prescriptions for a short-acting beta agonist during the pre-index period.
Who cannot join
- Patients with more than one of the study medications during the 3-month period beginning with the index date;
- One or more prescriptions within three months of index date (pre or post) for an ICS or LABA other than the study medications
- One or more prescriptions within three months of post index date for:
- Any asthma maintenance medication
- Any medical claims during study period with a diagnosis of: Chronic obstructive pulmonary disease (COPD) (ICD-9-CM 491, 492, or 496); or Respiratory tract cancer (ICD-9-CM 160-164, or 231)
About this study
This is an observational retrospective analysis of linked pharmacy and medical claims data from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median).
Subjects will be identified in the database that have at least one ICD-9 diagnostic code (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids. Subjects will be followed in the database until they have the event of interest (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related emergency department/hospitalization or asthma-related emergency department/hospitalization/oral corticosteroids) or until they are lost to follow up whichever comes first. Subjects can be censored if they leave the database, have the event of interest, or are dispensed another asthma controller other than the medication of interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical models adjusting for differences in baseline (pre-index) asthma and patient demographics will be used to compare asthma events.
- Conditions
- Asthma
- Being tested
- Higher-dose inhaled corticosteroids, Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combination
- Keywords
- outcomes, observational, retrospective, database, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher-dose inhaled corticosteroidsDrug
Also called Flovent® is a registered trademark of GlaxoSmithKline
fluticasone propionate 110 or 220 mcg
Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combinationDrug
Also called Advair ® is a registered trademark of GlaxoSmithKline
Low dose inhaled corticosteroids/salmeterol xinafoate (100mcg/50mcg or 250 mcg/50mcg)
| Study group | Role | What they receive |
|---|---|---|
| Adolescent and adult patients with asthma | Adolescents and Adults age 12-65 with an ICD-9 code for asthma and a prescription for an inhaled corticosteriod or a corticosteriod/salmeterol combination Receives: Drug: Higher-dose inhaled corticosteroids; Drug: Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma-related exacerbations
Asthma-related exacerbations contain resource utilization (ICD-9 code 493.xx) and/or asthma-related medications including asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related, emergency department/hospitalization or asthma-related, emergency department/hospitalization/oral corticosteroids
Measured: Outcomes period is at least 90 days during 5-year study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2012
- Study completionJan 2012
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
- 7,779 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
- NCT01431924
- Sponsor's protocol ID
- 113903
- Status last verified
- Feb 2013
- First submitted
- 8 Sep 2011
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observed Outcomes Associated With Fluticasone Propionate/Salmeterol Xinafoate or Inhaled Corticosteroids in Asthma Patients
- ClinicalTrials.gov ID
- NCT01431924
- Acronym / sponsor ID
- 113903
- Conditions
- Asthma
- Keywords
- outcomes, observational, retrospective, database, asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,779 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Sep 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.
This is an observational retrospective analysis of linked pharmacy and medical claims data from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median).
Subjects will be identified in the database that have at least one ICD-9 diagnostic code (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids. Subjects will be followed in the database until they have the event of interest (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related emergency department/hospitalization or asthma-related emergency department/hospitalization/oral corticosteroids) or until they are lost to follow up whichever comes first. Subjects can be censored if they leave the database, have the event of interest, or are dispensed another asthma controller other than the medication of interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical models adjusting for differences in baseline (pre-index) asthma and patient demographics will be used to compare asthma events.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent and adult patients with asthma | – | Drug: Higher-dose inhaled corticosteroids, Drug: Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combinationAdolescents and Adults age 12-65 with an ICD-9 code for asthma and a prescription for an inhaled corticosteriod or a corticosteriod/salmeterol combination |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asthma subjects identified from the IMS Health/Pharmetrics database, which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median). Subjects will be identified using asthma ICD-9 codes (493.xx) and use of asthma medications. Subjects will be between the ages of 12 and 65 without comorbid chronic obstruction pulmonary disease. To be included in the analysis, subjects will need a dispensing history of either fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or 100mcg/50mcg combinations or fluticasone propionate 110 mcg or 220 mcg.
Key inclusion criteria (6 listed)
- One or more medical claims with a diagnosis (primary or secondary) of asthma (ICD-9-CM 493.XX) during study period;
- One or more outpatient pharmacy claims during the study for one or more of the following "study medications":
- Fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or 100mcg/50mcg combinations
- Fluticasone propionate 110 mcg or 220 mcg
- One or more asthma exacerbations (asthma-related hospitalization or emergency department visit, oral corticosteriod prescription drug claim, or a combination of any of the above events) during the 12 months prior to the index date ("pre-index period") or
Key exclusion criteria (5 listed)
- Patients with more than one of the study medications during the 3-month period beginning with the index date;
- One or more prescriptions within three months of index date (pre or post) for an ICS or LABA other than the study medications
- One or more prescriptions within three months of post index date for:
- Any asthma maintenance medication
- Any medical claims during study period with a diagnosis of: Chronic obstructive pulmonary disease (COPD) (ICD-9-CM 491, 492, or 496); or Respiratory tract cancer (ICD-9-CM 160-164, or 231)
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 |
|---|---|---|
| Higher-dose inhaled corticosteroidsAlso: Flovent® is a registered trademark of GlaxoSmithKlinefluticasone propionate 110 or 220 mcg | Drug | Adolescent and adult patients with asthma |
| Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combinationAlso: Advair ® is a registered trademark of GlaxoSmithKlineLow dose inhaled corticosteroids/salmeterol xinafoate (100mcg/50mcg or 250 mcg/50mcg) | Drug | Adolescent and adult patients with asthma |
Primary outcome
Asthma-related exacerbations
Time frame: Outcomes period is at least 90 days during 5-year study period
Asthma-related exacerbations contain resource utilization (ICD-9 code 493.xx) and/or asthma-related medications including asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related, emergency department/hospitalization or asthma-related, emergency department/hospitalization/oral corticosteroids
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 25 Feb 2013.
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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 6 inclusion and 5 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 25 Feb 2013. 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?
Asthma-related exacerbations (time frame: Outcomes period is at least 90 days during 5-year study period). 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 25 Feb 2013.