Last updated: 11/07/2018 06:59:35
Outcomes Associated with Early or Delayed Maintenance Treatment Post-Chronic Obstructive Pulmonary Disease Exacerbation
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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