Pulmonary Disease, Chronic ObstructiveNCT01381406

Impact of Initiating Tiotropium Alone Versus Initiating Tiotropium in Combination With Fluticasone Propionate/Salmeterol Xinafoate Combination (FSC) on Chronic Obstructive Pulmonary Disease-related Outcomes in Patients With Pre-existing Exacerbations

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: TIO and TIO+FSC
How many people: 3,333 participants
Where: No sites listed yet
Study dates: Jul 2008to Sep 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 40 years and older
All sexes
Adult, Older adult

Study population: Data for managed-care enrollees age 40 and older with a diagnosis of COPD and an index event of at least one pharmacy claim for TIO during the study period (January 1, 2003 through April 30, 2008) were identified. Subjects were required to have ≥1 exacerbation in the pre-index period (defined as a COPD-related emergency room visit or hospitalization), ≥1 prescription claim for ipratropium or ipratropium/albuterol combination in the pre-index period, ≥2 prescriptions for TIO (including the index prescription) during the post-index period, no prescription for FSC during the pre-index period, and no exacerbation or hospital/emergency room visit within 30 days after the index date. ICD-9-CM code 490.xx, bronchitis not specified as chronic or acute, was included in an attempt to enhance the validity of the analysis by capturing patients with chronic bronchitis whose condition was coded incorrectly.

Who may be able to join

Continuous health plan eligibility in the pre- and post-index periods
age ≥40 years at the index date
Presence of at least 1 claim with an ICD-9-CM code for COPD in any diagnosis field (490.xx, 491.xx, 492.xx, 496.xx) in the pre- and post-index period
≥1 exacerbation in the pre-index period (defined as a COPD-related Emergency Room visit or hospitalization)
≥1 prescription claim for ipratropium or ipratropium/albuterol combination in the pre-index period
an index event of at least one pharmacy claim for TIO (tiotropium) combination in the pre-index period during the study period (January 1, 2003 through April 30, 2008)
≥2 prescriptions for TIO (including the index prescription) during the post-index period

Who cannot join

presence of comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis [TB], and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, sarcoidosis) during the pre- and post-index periods
use of FSC in pre-index period
exacerbation (emergency room visit or hospitalization) within 30 days after the index date

About this study

This was a retrospective cohort design using administrative claims data from Jan 1, 2003 through Sep 30, 2007, representing the years of available data, were used for this study. Managed care enrollees having at least one pharmacy claim for tiotropium (TIO) during the study period were identified as the target population. An index TIO prescription was defined as the first chronologically occurring pharmacy claim for TIO during the period Jan 1, 2004 to Aug 31, 2006, called the enrollment period. The date of the index TIO prescription was termed as the index Rx date, and the 1-year period before the index Rx date was termed as the pre-index period. The period after the index date was termed as the post-index date, and is further divided into a 30-day combination assessment period and a 1-year follow-up period. COPD clinical and economic outcomes were measured in a variable length follow up period.

The combination assessment period, defined as the 30-day period following the index Rx date, was used to categorize patients into 2 cohorts: TIO alone or TIO + FSC (fluticasone propionate/salmeterol xinofoate combination) depending on whether they use FSC in combination with TIO during this period. Combination therapy with TIO + FSC was defined as having an FSC claim on the same date as the TIO claim or a TIO and FSC pharmacy claim with overlapping days supply occurring within 30 days of index Rx date. Enrollees adding FSC for the first time after the 30-day combination assessment period were excluded from the sample, thus ensuring that the TIO-alone cohort is not using FSC. No outcomes were assessed in the 30-day combination assessment period. The 1-year period after the end of the 30-day combination assessment period was termed as the follow-up period and was used to assess all study outcomes. Enrollees were required to be continuously eligible in their health plans during the pre-index and post-index periods for a total of 25 months. An intent-to-treat approach was used for the analyses. Thus, patients identified to be in a drug therapy cohort were considered to be using that therapy during the entire follow-up period, regardless of therapy discontinuations.

Specifically the study hypothesis for the primary outcome being tested was:

Ho: There is no difference in risk of any COPD-related exacerbation between TIO+FSC and TIO cohorts Ha: There is a difference in risk of any COPD-related exacerbation between TIO+FSC and TIO 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 TIO+FSC and TIO cohorts Ha: There is a difference in COPD-related costs between TIO+FSC and TIO cohorts

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: TIO, TIO+FSC
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.

TIODrug
Also called Spiriva®
Patients receiving tiotropium bromide at index within the study period.
TIO+FSCDrug
Also called Spiriva ® + ADVAIR ®
Patients receiving tiotropium bromide plus fluticasone propionate-salmeterol xinafoate combination at time of index within the study period.

Study groups in NCT01381406
Study group	Role	What they receive
COPD patients		Patients who are at least 40 years of age and diagnosed with COPD using ICD-9 codes of 491.xx, 492.xx, and 496.xx in an administrative claims database. Receives: Drug: TIO; Drug: TIO+FSC

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
A severe exacerbation is defined as one with a primary diagnosis of COPD. A moderate exacerbation is an ED visit with a primary diagnosis of COPD, a physician visit with a diagnosis of COPD and a prescription for an oral corticosteroid, a physician visit with a diagnosis code for COPD and an antibiotic for respiratory infection, or physician administration of nebulized albuterol within 3 days of an office visit. Incidence rate is calculated by dividing the number of exacerbations by the number of person years. Person years adjust for different lengths of follow up for participants.
Measured: Data were collected over a maximum period of 4 years

Secondary outcomes (2)

Adjusted Mean Monthly Costs Per COPD Patient by Treatment Group
The mean costs of health care encounters adjusted to control for baseline differences between treatment groups and reported in 2008 United States dollars as calculated with the consumer price index (CPI) are presented. CPI is standard multiplier for adjusting the cost of goods and services to a single year. Total costs include pharmacy and medical costs. Medical costs were computed from the paid amounts of medical claims with a primary diagnosis code for COPD. COPD-related pharmacy costs were computed from paid amounts of COPD-related prescription medications.
Measured: Data were collected over a maximum period of 4 years
Incidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years
Unadjusted incidence rates per 100 person years of chronic obstructive pulmonary disease (COPD)-related hospitalizations and emergency department visits by treatment group are presented. Incidence rate is calculated by dividing the number of healthcare service encounters by the number of person years of follow up. Person years adjust for different lengths of follow up for individual participants
Measured: Data were collected over a maximum period of 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Sep 2010

First posted27 Jun 2011 (estimated)
Study startJul 2008
Primary completionJun 2010
Study completionSep 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 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: 3,333 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01381406
Sponsor's protocol ID: 111266
Status last verified: May 2017
First submitted: 23 Jun 2011
Last updated: 14 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Initiating Tiotropium Alone Versus Initiating Tiotropium in Combination With Fluticasone Propionate/Salmeterol Xinafoate Combination (FSC) on Chronic Obstructive Pulmonary Disease-related Outcomes in Patients With Pre-existing Exacerbations
ClinicalTrials.gov ID: NCT01381406
Acronym / sponsor ID: 111266
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 3,333 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Jun 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 27 Jun 2011 (estimated)
Results: Posted 21 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Specifically the study hypothesis for the primary outcome being tested was:

Ho: There is no difference in risk of any COPD-related exacerbation between TIO+FSC and TIO cohorts Ha: There is a difference in risk of any COPD-related exacerbation between TIO+FSC and TIO 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 TIO+FSC and TIO cohorts Ha: There is a difference in COPD-related costs between TIO+FSC and TIO cohorts

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
COPD patients	–	Drug: TIO, Drug: TIO+FSCPatients who are at least 40 years of age and diagnosed with COPD using ICD-9 codes of 491.xx, 492.xx, and 496.xx in an administrative claims database.

Who may qualify

Ages: 40 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Data for managed-care enrollees age 40 and older with a diagnosis of COPD and an index event of at least one pharmacy claim for TIO during the study period (January 1, 2003 through April 30, 2008) were identified. Subjects were required to have ≥1 exacerbation in the pre-index period (defined as a COPD-related emergency room visit or hospitalization), ≥1 prescription claim for ipratropium or ipratropium/albuterol combination in the pre-index period, ≥2 prescriptions for TIO (including the index prescription) during the post-index period, no prescription for FSC during the pre-index period, and no exacerbation or hospital/emergency room visit within 30 days after the index date. ICD-9-CM code 490.xx, bronchitis not specified as chronic or acute, was included in an attempt to enhance the validity of the analysis by capturing patients with chronic bronchitis whose condition was coded incorrectly.

Key inclusion criteria (7 listed)

Continuous health plan eligibility in the pre- and post-index periods
age ≥40 years at the index date
Presence of at least 1 claim with an ICD-9-CM code for COPD in any diagnosis field (490.xx, 491.xx, 492.xx, 496.xx) in the pre- and post-index period
≥1 exacerbation in the pre-index period (defined as a COPD-related Emergency Room visit or hospitalization)
≥1 prescription claim for ipratropium or ipratropium/albuterol combination in the pre-index period

Key exclusion criteria (3 listed)

presence of comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis [TB], and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, sarcoidosis) during the pre- and post-index periods
use of FSC in pre-index period
exacerbation (emergency room visit or hospitalization) within 30 days after the index date

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
TIOAlso: Spiriva®Patients receiving tiotropium bromide at index within the study period.	Drug	COPD patients
TIO+FSCAlso: Spiriva ® + ADVAIR ®Patients receiving tiotropium bromide plus fluticasone propionate-salmeterol xinafoate combination at time of index within the study period.	Drug	COPD patients

Primary outcome

Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Time frame: Data were collected over a maximum period of 4 years
A severe exacerbation is defined as one with a primary diagnosis of COPD. A moderate exacerbation is an ED visit with a primary diagnosis of COPD, a physician visit with a diagnosis of COPD and a prescription for an oral corticosteroid, a physician visit with a diagnosis code for COPD and an antibiotic for respiratory infection, or physician administration of nebulized albuterol within 3 days of an office visit. Incidence rate is calculated by dividing the number of exacerbations by the number of person years. Person years adjust for different lengths of follow up for participants.

2 secondary outcomes

Adjusted Mean Monthly Costs Per COPD Patient by Treatment Group
Time frame: Data were collected over a maximum period of 4 years
Incidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years
Time frame: Data were collected over a maximum period of 4 years

Results and safety

Results posted to the registry on 21 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tiotropium Bromide (TIO)	2,481	2,481
TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)	852	852

Primary outcome: Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Time frame: Data were collected over a maximum period of 4 years. Number. Unit: exacerbations per 100 person years

Measure	Tiotropium Bromide (TIO) n = 2481	TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC) n = 852
Any exacerbation	95.58	75.38
Severe exacerbation	7.86	5.06
Moderate exacerbation	88.65	69.74

Tiotropium Bromide (TIO) vs TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC): Hazard Ratio (HR): 0.772 (95% CI 0.641 to 0.930), p = 0.007, Regression, Logistic
Tiotropium Bromide (TIO) vs TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC): Hazard Ratio (HR): 0.622 (95% CI 0.328 to 1.180), p = 0.146, Regression, Logistic
Tiotropium Bromide (TIO) vs TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC): Hazard Ratio (HR): 0.763 (95% CI 0.646 to 0.949), p = 0.013, Regression, Logistic

Population analysed: Managed care enrollees (aged \>40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tiotropium Bromide (TIO)	0 of 0	0 of 0	Not reported
TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 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 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 7 inclusion and 3 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 14 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?

Yes. Results are posted in the registry (first posted 21 Oct 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?

Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) (time frame: Data were collected over a maximum period of 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01381406.

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 14 Jun 2017.