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

NCT01431911 | Completed

• 1 other identifier: 113898
• Study Type: observational
• Target: 3,806
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• COPD hospitalization/ED visit

  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.

  Up to 6 years (January 1, 2003 through June 30, 2009)

Secondary Outcomes (4)

• COPD-related ED visit

  Up to 6 years (January 1, 2003 through June 30, 2009)

• COPD-related hospitalization

  Up to 6 years (January 1, 2003 through June 30, 2009)

• COPD-related Phy+Rx visit

  January 1, 2003 through June 30, 2009 (up to 6 years)

• COPD related Costs

  January 1, 2003 through June 30, 2009 (up to 6 years)

Study Arms (1)

Patients diagnosed with COPD

Patients diagnosed with COPD using ICD codes with a COPD-related exacerbation and receiving maintenance therapy

Drug: Early maintenance treatment; Drug: Delayed Maintenance treatment

Interventions

Early maintenance treatment DRUG

Various classes of COPD maintenance treatment initiated within 30 days post index COPD exacerbation (hospitalization/ED visit)

Patients diagnosed with COPD

Delayed Maintenance treatment DRUG

Various classes of COPD maintenance treatment initiated after 30 days post index COPD exacerbation (hospitalization/ED visit)

Patients diagnosed with COPD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: September 12, 2011
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: May 16, 2017

Record last verified: 2017-05