Pulmonary Disease, Chronic ObstructiveNCT01395875
Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline.
Trial summary
Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of all diagnosed COPD patients. Yet limited data exists on characterizing this study population in terms of drug therapy patterns and COPD-related resource use and costs. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC) and Anticholinergics (AC)
- Type of treatment
- Pill or oral medicine
- How many people
- 2,849 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jun 2011
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data from January 1, 2003 to March 31, 2009 will be available and termed as the study period. Patients with at least one moderate exacerbation defined as a physician/outpatient visit with a primary diagnosis of COPD (ICD-9 diagnosis codes) and having an oral corticosteroid (OCS) or antibiotic (ABX) prescription within 5 days of physician/outpatient visit will be identified as the target population. The date of this first moderate exacerbation will serve as the patient's index date, and will be identified during an identification period of January 1, 2004 to March 31, 2008 allowing for a maximum of a 1-year period before (pre-period) and after the index date (follow-up). The specific dates for the pre- and follow-up periods will be different for each patient depending on their index date. Furthermore this index moderate exacerbation should be the first medical claim with a primary diagnosis of COPD to ensure that only patients with moderate exacerbations will be captured.
Who may be able to join
- minimum age 40 years at index
- continuously enrolled in health plan
- diagnosis of COPD (ICD-9 codes of 491, 492, 496)
- at least one moderate exacerbation event as defined previously.
Who cannot join
- Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, or sarcoidosis
- Patients excluded if they did not receive treatment within the treatment assessment period following moderate exacerbation
- Receipt of maintenance medication in the pre-period
- Presence of treatment switch, discontinuation of index drug, or any COPD-related exacerbation during the treatment assessment period
About this study
Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of all diagnosed COPD patients. Yet limited data exists on characterizing this study population in terms of drug therapy patterns and COPD-related resource use and costs. The objective of the following study was to conduct an analysis in the real-world setting to (1) identify and characterize COPD patients with moderate exacerbations and (2) evaluate the impact of initiating different maintenance therapies in this population. Maintenance therapy medications include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs), combination of ICS+LABA, and anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]).
Read the detailed description
Data from January 1, 2003 to March 31, 2009 will be available and termed as the study period. Patients with at least one moderate exacerbation defined as a physician/outpatient visit with a primary diagnosis of COPD and having an oral corticosteroid (OCS) or antibiotic prescription (ABX) within 5 days of physician/outpatient visit will be identified as the target population. The date of the first moderate exacerbation will serve as the patient's index date, and will be identified during the identification period of January 1, 2004 through February 28, 2009. Furthermore this moderate exacerbation should be the first medical claim with a primary diagnosis of COPD to ensure that only patients with moderate exacerbations will be captured. Subsequently, patients will be categorized into study cohorts based on the first maintenance drug prescription (index drug) received during the 30-day period after the index date termed as the treatment assessment period. Maintenance drugs considered include fluticasone-salmeterol 250/50 mcg (FSC) or anticholinergics (AC) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]). Patients not receiving any maintenance medication or those receiving maintenance medications other than those considered during the treatment assessment period will be excluded.
All outcomes will be assessed during a follow-up period that will vary in length between 1 day and 1 year for each patient. The variable follow-up period will be defined as the period that starts on the day after the treatment assessment period, and ends on the earliest of the following event dates: the end of the study period (March 31, 2009), the end of the patient's continuous eligibility in the health plan, the end of the patient's 1-year follow-up, treatment switch date (ie, a switch to any study medication different from the index drug), discontinuation date of the index drug (ie, more than a 60-day gap between the end of the days' supply of the preceding prescription and the fill date of the next consecutive prescription), or occurrence of any COPD-related exacerbation (COPD-related hospitalization, ED visit, or physician/outpatient visit with a prescription for an oral corticosteroid or antibiotic within 5 days of the visit).
A 1-year period before the index date (pre-period) will be used to provide a baseline assessment of the study cohorts. The specific dates for the pre- and follow-up periods will vary for each patient depending on their index date.
Specifically the study hypothesis for the primary outcome being tested was:
Ho: There is no difference in risk of any COPD-related exacerbation between FSC and AC cohorts Ha: There is a difference in risk of any COPD-related exacerbation between FSC and AC cohorts
Hypothesis for the key secondary outcome of COPD-related costs that was tested was:
Ho: There is no difference in COPD-related costs between FSC and AC cohorts Ha: There is a difference in COPD-related costs between FSC and AC cohorts
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC), Anticholinergics (AC)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC)Drug
Also called Advair (TM)
COPD patients receiving fluticasone propionate/salmeterol xinafoate combination (FSC) 250/50mcg
Anticholinergics (AC)Drug
Also called Spiriva (TM), Atrovent (TM), Combivent (TM)
COPD patients receiving anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]).
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with moderate exacerbations | COPD patients with COPD-related using ICD-9 codes physician office/outpatient visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit (Phy+Rx) Receives: Drug: Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC); Drug: Anticholinergics (AC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of any COPD-related exacerbation
risk of the following types of COPD-related exacerbations between patients receiving FSC vs AC: COPD-related physician office/outpatient visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit (Phy+Rx) and/or COPD-related hospitalization or an ED visit
Measured: January 1, 2003 to March 31, 2009 (up to 6 years)
Secondary outcomes (3)
Moderate COPD exacerbation
Risk of COPD-related exacerbations for patients with physician office/outpatient visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit (Phy+Rx).
Measured: January 1, 2003 to March 31, 2009 (up to 6 years)
COPD-related hospitalization/ED
Risk of COPD-related exacerbations for patients with COPD hospitalization with primary diagnosis code for COPD and ED visits with the same.
Measured: January 1, 2003 to March 31, 2009 (up to 6 years)
COPD-related Costs
Comparing average monthly COPD-related costs and cost components between patients receiving FSC vs AC. Medical, pharmacy and total costs were examined
Measured: January 1, 2003 to March 31, 2009 (up to 6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 2,849 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
- NCT01395875
- Sponsor's protocol ID
- 113901
- Status last verified
- May 2017
- First submitted
- 14 Jul 2011
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes for Chronic Obstructive Pulmonary Disease Moderate Exacerbators Initiating Treatment
- ClinicalTrials.gov ID
- NCT01395875
- Acronym / sponsor ID
- 113901
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,849 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Jul 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.
Patients with moderate COPD as defined by GOLD guidelines constitute almost 46% to 54% of all diagnosed COPD patients. Yet limited data exists on characterizing this study population in terms of drug therapy patterns and COPD-related resource use and costs. The objective of the following study was to conduct an analysis in the real-world setting to (1) identify and characterize COPD patients with moderate exacerbations and (2) evaluate the impact of initiating different maintenance therapies in this population. Maintenance therapy medications include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs), combination of ICS+LABA, and anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]).
Detailed description
Data from January 1, 2003 to March 31, 2009 will be available and termed as the study period. Patients with at least one moderate exacerbation defined as a physician/outpatient visit with a primary diagnosis of COPD and having an oral corticosteroid (OCS) or antibiotic prescription (ABX) within 5 days of physician/outpatient visit will be identified as the target population. The date of the first moderate exacerbation will serve as the patient's index date, and will be identified during the identification period of January 1, 2004 through February 28, 2009. Furthermore this moderate exacerbation should be the first medical claim with a primary diagnosis of COPD to ensure that only patients with moderate exacerbations will be captured. Subsequently, patients will be categorized into study cohorts based on the first maintenance drug prescription (index drug) received during the 30-day period after the index date termed as the treatment assessment period. Maintenance drugs considered include fluticasone-salmeterol 250/50 mcg (FSC) or anticholinergics (AC) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]). Patients not receiving any maintenance medication or those receiving maintenance medications other than those considered during the treatment assessment period will be excluded.
All outcomes will be assessed during a follow-up period that will vary in length between 1 day and 1 year for each patient. The variable follow-up period will be defined as the period that starts on the day after the treatment assessment period, and ends on the earliest of the following event dates: the end of the study period (March 31, 2009), the end of the patient's continuous eligibility in the health plan, the end of the patient's 1-year follow-up, treatment switch date (ie, a switch to any study medication different from the index drug), discontinuation date of the index drug (ie, more than a 60-day gap between the end of the days' supply of the preceding prescription and the fill date of the next consecutive prescription), or occurrence of any COPD-related exacerbation (COPD-related hospitalization, ED visit, or physician/outpatient visit with a prescription for an oral corticosteroid or antibiotic within 5 days of the visit).
A 1-year period before the index date (pre-period) will be used to provide a baseline assessment of the study cohorts. The specific dates for the pre- and follow-up periods will vary for each patient depending on their index date.
Specifically the study hypothesis for the primary outcome being tested was:
Ho: There is no difference in risk of any COPD-related exacerbation between FSC and AC cohorts Ha: There is a difference in risk of any COPD-related exacerbation between FSC and AC cohorts
Hypothesis for the key secondary outcome of COPD-related costs that was tested was:
Ho: There is no difference in COPD-related costs between FSC and AC cohorts Ha: There is a difference in COPD-related costs between FSC and AC cohorts
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients with moderate exacerbations | – | Drug: Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC), Drug: Anticholinergics (AC)COPD patients with COPD-related using ICD-9 codes physician office/outpatient visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit (Phy+Rx) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from January 1, 2003 to March 31, 2009 will be available and termed as the study period. Patients with at least one moderate exacerbation defined as a physician/outpatient visit with a primary diagnosis of COPD (ICD-9 diagnosis codes) and having an oral corticosteroid (OCS) or antibiotic (ABX) prescription within 5 days of physician/outpatient visit will be identified as the target population. The date of this first moderate exacerbation will serve as the patient's index date, and will be identified during an identification period of January 1, 2004 to March 31, 2008 allowing for a maximum of a 1-year period before (pre-period) and after the index date (follow-up). The specific dates for the pre- and follow-up periods will be different for each patient depending on their index date. Furthermore this index moderate exacerbation should be the first medical claim with a primary diagnosis of COPD to ensure that only patients with moderate exacerbations will be captured.
Key inclusion criteria (4 listed)
- minimum age 40 years at index
- continuously enrolled in health plan
- diagnosis of COPD (ICD-9 codes of 491, 492, 496)
- at least one moderate exacerbation event as defined previously.
Key exclusion criteria (4 listed)
- Exclusionary comorbid conditions of respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis (TB), bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, or sarcoidosis
- Patients excluded if they did not receive treatment within the treatment assessment period following moderate exacerbation
- Receipt of maintenance medication in the pre-period
- Presence of treatment switch, discontinuation of index drug, or any COPD-related exacerbation during the treatment assessment 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 Propionate / Salmeterol Xinafoate Combination (FSC)Also: Advair (TM)COPD patients receiving fluticasone propionate/salmeterol xinafoate combination (FSC) 250/50mcg | Drug | COPD patients with moderate exacerbations |
| Anticholinergics (AC)Also: Spiriva (TM), Atrovent (TM), Combivent (TM)COPD patients receiving anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]). | Drug | COPD patients with moderate exacerbations |
Primary outcome
risk of any COPD-related exacerbation
Time frame: January 1, 2003 to March 31, 2009 (up to 6 years)
risk of the following types of COPD-related exacerbations between patients receiving FSC vs AC: COPD-related physician office/outpatient visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit (Phy+Rx) and/or COPD-related hospitalization or an ED visit
3 secondary outcomes
Moderate COPD exacerbation
Time frame: January 1, 2003 to March 31, 2009 (up to 6 years)
COPD-related hospitalization/ED
Time frame: January 1, 2003 to March 31, 2009 (up to 6 years)
COPD-related Costs
Time frame: January 1, 2003 to March 31, 2009 (up to 6 years)
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 16 May 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 Pulmonary Disease, Chronic Obstructive, 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 4 inclusion and 4 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 16 May 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?
risk of any COPD-related exacerbation (time frame: January 1, 2003 to March 31, 2009 (up to 6 years)). 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 16 May 2017.