Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients

NCT01346852 | Completed Results

• 1 other identifier: 112607
• Study Type: observational
• Target: 101,437
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the predictive ability of three asthma risk markers: the ratio of controller medication to total asthma medication, an albuterol only marker, and an oral corticosteroid use marker, as well as to compare the precision of these tools between adult and pediatric patient populations. This retrospective longitudinal analysis will use 2 different databases: a large managed care database and a large fee for service Medicaid database.

Conditions

Asthma

Keywords

pediatrics; Medicaid; asthma; outcomes; asthma medication ratio

Outcome Measures

Primary Outcomes (1)

• Mean Ratio of Controller Medication to Total Asthma Medication

  The ratio of controller medication (CM) to total asthma medication (AM), which is well established in predicting future asthma events in adults, was calculated as the ratio of the units of CMs used during the defined period divided by the sum of the units of CMs plus the units of inhaled short-acting beta-agonists used during the same period. A CM is defined as any inhaled corticosteroid containing medication, methylxanthines, leukotriene receptor antagonists, or cromolyn sodium. The ratio is calculated using all CM. Asthma controllers are medications used to treat asthma on a regular basis.

  January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods

Secondary Outcomes (1)

• Mean Number of Short-acting Beta-agonist (SABA) Canisters Used

  January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods

Study Arms (2)

Pediatric participants

Pediatric participants (age 4 to 17) with a diagnosis of asthma

Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication

Adult participants

Adult participants (age 18 and older) with a diagnosis of asthma

Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication

Interventions

Asthma treatment with an asthma-related medication and at least one asthma controller medication DRUG

participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol.

Adult participants; Pediatric participants

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study intends to identify subjects at least 4 years of age with asthma and using asthma medications

You may qualify if:

• Subjects with asthma as determined by ICD-9 codes and asthma drug use
• at least 4 years of age
• use of at least 1 controller or at least 5 albuterol prescriptions in 12 months

You may not qualify if:

• Subjects with COPD or treatment for COPD

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: May 3, 2011
• Study Start: July 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 30, 2017
• Results First Posted: June 1, 2011

Record last verified: 2017-05