Last updated: 11/07/2018 06:59:35

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

GSK study ID
113898
See study documents
Clinicaltrials.gov ID
NCT01431911
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Outcomes Associated with Early or Delayed Maintenance Treatment Post-Chronic Obstructive Pulmonary Disease Exacerbation
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

COPD hospitalization/ED visit

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

Secondary outcomes:

COPD-related ED visit

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

COPD-related hospitalization

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

COPD-related Phy+Rx visit

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

COPD related Costs

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

Interventions:
  • Drug: Early maintenance treatment
  • Drug: Delayed Maintenance treatment
    • Enrollment:
    3806
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Dalal AA, Shah MB, D’Souza AO, Dhamane A, Crater GD.Outcomes associated with timing of maintenance treatment for COPD exacerbation.Am J Manag Care.2012;18(9):e338-345
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    October 2010 to December 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    None
    • at least 40 years of age,
    • continuously enrolled for medical and pharmacy benefits during their pre- and post-period
    • 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
    Inclusion and exclusion 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).

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-01-12

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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