Observed Outcomes Associated With Fluticasone Propionate/Salmeterol Xinafoate or Inhaled Corticosteroids in Asthma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01431924
First received: September 8, 2011
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

This is an observational retrospective analysis of linked pharmacy and medical claims data from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median).

Subjects will be identified in the database that have at least one ICD-9 diagnostic code (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids. Subjects will be followed in the database until they have the event of interest (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related emergency department/hospitalization or asthma-related emergency department/hospitalization/oral corticosteroids) or until they are lost to follow up whichever comes first. Subjects can be censored if they leave the database, have the event of interest, or are dispensed another asthma controller other than the medication of interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical models adjusting for differences in baseline (pre-index) asthma and patient demographics will be used to compare asthma events.


Condition Intervention
Asthma
Drug: Higher-dose inhaled corticosteroids
Drug: Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observed Outcomes Associated With Fluticasone Propionate/Salmeterol Xinafoate or Inhaled Corticosteroids in Asthma Patients

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Asthma-related exacerbations [ Time Frame: Outcomes period is at least 90 days during 5-year study period ] [ Designated as safety issue: No ]
    Asthma-related exacerbations contain resource utilization (ICD-9 code 493.xx) and/or asthma-related medications including asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related, emergency department/hospitalization or asthma-related, emergency department/hospitalization/oral corticosteroids


Enrollment: 7779
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adolescent and adult patients with asthma
Adolescents and Adults age 12-65 with an ICD-9 code for asthma and a prescription for an inhaled corticosteriod or a corticosteriod/salmeterol combination
Drug: Higher-dose inhaled corticosteroids
fluticasone propionate 110 or 220 mcg
Other Name: Flovent® is a registered trademark of GlaxoSmithKline
Drug: Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combination
Low dose inhaled corticosteroids/salmeterol xinafoate (100mcg/50mcg or 250 mcg/50mcg)
Other Name: Advair ® is a registered trademark of GlaxoSmithKline

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Asthma subjects identified from the IMS Health/Pharmetrics database, which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median). Subjects will be identified using asthma ICD-9 codes (493.xx) and use of asthma medications. Subjects will be between the ages of 12 and 65 without comorbid chronic obstruction pulmonary disease. To be included in the analysis, subjects will need a dispensing history of either fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or 100mcg/50mcg combinations or fluticasone propionate 110 mcg or 220 mcg.

Criteria

Inclusion Criteria:

  • One or more medical claims with a diagnosis (primary or secondary) of asthma (ICD-9-CM 493.XX) during study period;
  • One or more outpatient pharmacy claims during the study for one or more of the following "study medications":
  • Fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or 100mcg/50mcg combinations
  • Fluticasone propionate 110 mcg or 220 mcg
  • One or more asthma exacerbations (asthma-related hospitalization or emergency department visit, oral corticosteriod prescription drug claim, or a combination of any of the above events) during the 12 months prior to the index date ("pre-index period") or
  • Five or more prescriptions for a short-acting beta agonist during the pre-index period.

Exclusion Criteria:

  • Patients with more than one of the study medications during the 3-month period beginning with the index date;
  • One or more prescriptions within three months of index date (pre or post) for an ICS or LABA other than the study medications
  • One or more prescriptions within three months of post index date for:
  • Any asthma maintenance medication
  • Any medical claims during study period with a diagnosis of: Chronic obstructive pulmonary disease (COPD) (ICD-9-CM 491, 492, or 496); or Respiratory tract cancer (ICD-9-CM 160-164, or 231)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431924

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01431924     History of Changes
Other Study ID Numbers: 113903
Study First Received: September 8, 2011
Last Updated: February 21, 2013
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
outcomes
observational
retrospective
database
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Albuterol
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Anti-Inflammatory Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 19, 2014