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Trial record 48 of 321 for:    FLUTICASONE AND SALMETEROL

Outcomes in Patients Taking Fluticasone Propionate/Salmeterol Combination or Other Inhaled Corticosteroids

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: NCT01332344
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date March 4, 2010
First Posted Date April 11, 2011
Last Update Posted Date June 2, 2017
Study Start Date June 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 7, 2011)
To assess the difference in asthma related exacerbations [ Time Frame: 90 days post index ]
Asthma related exaceberation is defined as any asthma related emergency department visit, or inpatient visit or oral corticosteroid dispensing.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01332344 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes in Patients Taking Fluticasone Propionate/Salmeterol Combination or Other Inhaled Corticosteroids
Official Title Comparison of Healthcare Utilization and Costs in Patients With Asthma Who Fluticasone/Salmeterol Inhalation Powder Versus Other Inhaled Corticosteroid(s) in Typical Clinical Practice Using Health Insurance Claims Data.
Brief Summary The objective of this study is to compare healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg ("FSC 100/50") or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care database.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study intends to identify subjects with asthma treated with inhaled corticosteroids
Condition Asthma
Intervention
  • Drug: Fluticasone propionate/salmeterol combination
    Asthma subjects newly prescribed fluticasone propionate/salmeterol combination
  • Drug: Inhaled corticosteroids
    asthma subjects newly prescribed inhaled corticosteroids in clinical practice
Study Groups/Cohorts Asthma patients treated with inhaled corticosteroids
Asthma subjects newly prescribed inhaled corticosteriods
Interventions:
  • Drug: Fluticasone propionate/salmeterol combination
  • Drug: Inhaled corticosteroids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 1, 2011)
5180
Original Actual Enrollment
 (submitted: April 7, 2011)
0
Actual Study Completion Date June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects with asthma as determined by ICD-9 codes and asthma drug use
  • at least 12 years of age
  • treated with inhaled corticosteroids

Exclusion Criteria:

  • Subjects with COPD or treatment for COPD
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01332344
Other Study ID Numbers 112604
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2017