ClinicalTrials.gov
ClinicalTrials.gov Menu

Outcomes Associated With Early or Delayed Maintenance Treatment Post-Chronic Obstructive Pulmonary Disease Exacerbation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01431911
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The timing of initiating short-term treatment for COPD exacerbations with oral corticosteroids and/or antibiotic therapy has been shown to influence the recovery time of exacerbations with early initiation of exacerbation therapy having a faster symptom recovery compared to delayed initiation. While oral corticosteroids and/or antibiotic therapy are crucial for immediate exacerbation therapy, maintenance therapy with controller medications for COPD has been recommended to reduce the risk of future exacerbations. The initiation of maintenance therapy after a COPD exacerbation has been shown to be beneficial in the reduction of risk of future exacerbations. However, there is a lack of information on whether the timing of this initiation influences the risk of future exacerbations. The following study evaluates the impact of early versus delayed initiation of controller medication therapy for maintenance treatment following a COPD-related exacerbation on outcomes of future exacerbations and costs in patients with COPD.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Early maintenance treatment Drug: Delayed Maintenance treatment

Detailed Description:

Study period for this analysis will range from January 2003 through June 2009. Patients with at least one COPD exacerbation will be selected as the initial population. Three types of COPD exacerbations will be identified: 1) hospitalization with a primary discharge diagnosis code for COPD, 2) an emergency department (ED) visit with a primary diagnosis code for COPD, 3) physician visit with a dispensing of oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit. Only the first two will be selected as index exacerbations, which is defined as the first chronologically occurring exacerbation for a patient. For hospitalization exacerbations the discharge date of the hospitalization will be the index date and for ED exacerbations the date of the visit will be the index date. The pre-index period will be defined as the 1-year period before index date and the post-index period will be defined as 1-year period after index date. The enrollment period will thus range from January 1, 2004 through June 30, 2008. The post-index period will be used to identify the date of receipt of prescription for first COPD maintenance medication. This date of receipt will be used to compute the time to start maintenance treatment. Maintenance treatment refers to the use of controller medications.

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

Ho: There is no difference in risk of COPD-related hospitalization/ED visit between early and delayed cohorts Ha: There is a difference in risk of COPD-related hospitalization/ED visit between early and delayed 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 early and delayed cohorts Ha: There is a difference in COPD-related costs between early and delayed cohorts


Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 3806 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcomes Associated With Early or Delayed Maintenance Treatment Post-Chronic Obstructive Pulmonary Disease Exacerbation
Study Start Date : October 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patients diagnosed with COPD
Patients diagnosed with COPD using ICD codes with a COPD-related exacerbation and receiving maintenance therapy
 Drug: Early maintenance treatment
Various classes of COPD maintenance treatment initiated within 30 days post index COPD exacerbation (hospitalization/ED visit)
Drug: Delayed Maintenance treatment
Various classes of COPD maintenance treatment initiated after 30 days post index COPD exacerbation (hospitalization/ED visit)


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. COPD hospitalization/ED visit [ Time Frame: Up to 6 years (January 1, 2003 through June 30, 2009) ]
    Risk and number of COPD exacerbations will be computed in the post-index period. Hospitalization with a primary discharge diagnosis code (ICD code 491.xx, 492.xx, and 496.xx) for COPD. ED visit will be defined as COPD related if accompanied by diagnosis code for COPD.


Secondary Outcome Measures :
  1. COPD-related ED visit [ Time Frame: Up to 6 years (January 1, 2003 through June 30, 2009) ]
    The risk and proportion of patients with a COPD-related exacerbation requiring ED visit was defined as a COPD-related ED visit.

  2. COPD-related hospitalization [ Time Frame: Up to 6 years (January 1, 2003 through June 30, 2009) ]
    risk and number of COPD hospitalizations will be computed in the post-index period. Hospitalization with a primary discharge diagnosis code (ICD code 491.xx, 492.xx, and 496.xx) for COPD will be captured.

  3. COPD-related Phy+Rx visit [ Time Frame: January 1, 2003 through June 30, 2009 (up to 6 years) ]
    Risk and number of COPD-related physician office visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit

  4. COPD related Costs [ Time Frame: January 1, 2003 through June 30, 2009 (up to 6 years) ]
    COPD related medical, pharmacy and total costs. Costs were standardized to 2009 US dollars (USD) using consumer price index for US medical care.


Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients meeting study criteria mentioned belowwere classified into two cohorts, early and delayed, based on timing of (maintenance treatment) MTx after the index date - 0 to 30 days and 31 to 180 days, respectively. A 30-day period was chosen to define early initiation based on sample size considerations and recent evidence demonstrating the increased risk of subsequent exacerbations during an 8-week period following an initial exacerbation [Hurst JR 2009]. Outcomes were computed for and compared between these two cohorts. An incremental analysis evaluating the effect of delaying MTx by every 30 days was also done classifying patients into six categories based on 30-day increments of starting MTx (0 to 30 days, 31 to 60 days, 61 to 90 days, 91 to 120 days, 121 to 150 days, and 151 to 180 days) (Figure 1). Outcomes were then compared across the 6 categories thereby allowing assessment for every 30-day increment up to 180 days after the index date.
Criteria

Inclusion Criteria:

  • at least 40 years of age,
  • continuously enrolled for medical and pharmacy benefits during their pre- and post-period
  • diagnosis of COPD (ICD 491.xx, 492.xx, 496.xx)

Exclusion Criteria:

  • Patients were excluded if they had MTx in the pre-index period (to ensure inclusion of MTx-naïve patients) or if they received their first MTx during 181 to 365 days of the post-period (as dispensing of MTx unlikely to be related to the index exacerbation).
  • Additionally, patients were excluded if they had any of the following comorbid conditions anytime during the study period: respiratory cancer, cystic fibrosis, fibrosis due to, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, or sarcoidosis, and
  • also if they had other doses (unapproved in the US) of fluticasone propionate-salmeterol xinafoate combination (100/50 mcg or 500/50 mcg) or budesonide dipropionate-formoterol fumarate fixed dose combination (any dose).
Contacts and Locations
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431911


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01431911     History of Changes
Other Study ID Numbers: 113898
First Posted: September 12, 2011    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
 Disease Progression
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes