Trial Outcomes & Findings for Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients (NCT NCT01346852)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

101437 participants

Primary outcome timeframe

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

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Pediatric Participants Diagnosed With Asthma Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.	Adult Participants Diagnosed With Asthma Adult (\>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
Overall Study STARTED	41753	59684
Overall Study COMPLETED	41753	59684
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pediatric Participants Diagnosed With Asthma n=41753 Participants Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.	Adult Participants Diagnosed With Asthma n=59684 Participants Adult (\>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.	Total n=101437 Participants Total of all reporting groups
Age, Continuous	10.1 Years STANDARD_DEVIATION 4.0 • n=5 Participants	43.6 Years STANDARD_DEVIATION 13.3 • n=7 Participants	29.8 Years STANDARD_DEVIATION 19.5 • n=5 Participants
Sex: Female, Male Female	18339 Participants n=5 Participants	38211 Participants n=7 Participants	56550 Participants n=5 Participants
Sex: Female, Male Male	23414 Participants n=5 Participants	21473 Participants n=7 Participants	44887 Participants n=5 Participants

PRIMARY outcome

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

Population: Ingenix Impact National Managed Care Database members who had \>=1 ICD-9 code for asthma and had \>= 1 controller medication or \>=5 albuterol canisters dispensed identified in the database during the 12-month identification period (pre-index). We tested 3 different capture/follow-up periods; thus, sample sizes varied depending capture period used.

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.

Outcome measures

Outcome measures
Measure	Pediatric Participants Diagnosed With Asthma n=40659 Participants Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.	Adult Participants Diagnosed With Asthma n=59174 Participants Adult (\>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
Mean Ratio of Controller Medication to Total Asthma Medication 3 months, n=40419, 59016	0.57 ratio Standard Deviation 0.34	0.66 ratio Standard Deviation 0.34
Mean Ratio of Controller Medication to Total Asthma Medication 6 months, n=40525, 59091	0.66 ratio Standard Deviation 0.26	0.71 ratio Standard Deviation 0.29
Mean Ratio of Controller Medication to Total Asthma Medication 12 months, n=40659, 59174	0.63 ratio Standard Deviation 0.26	0.70 ratio Standard Deviation 0.29

SECONDARY outcome

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

Population: Ingenix Impact National Managed Care Database members who had \>=1 ICD-9 code for asthma and had \>= 1 controller medication or \>=1 albuterol canister dispensed during the 12-month pre-index period.

The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population.

Outcome measures

Outcome measures
Measure	Pediatric Participants Diagnosed With Asthma n=41753 Participants Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.	Adult Participants Diagnosed With Asthma n=59684 Participants Adult (\>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
Mean Number of Short-acting Beta-agonist (SABA) Canisters Used 3 months	1.03 canisters Standard Deviation 0.90	1.04 canisters Standard Deviation 1.06
Mean Number of Short-acting Beta-agonist (SABA) Canisters Used 6 months	1.24 canisters Standard Deviation 1.18	1.28 canisters Standard Deviation 1.57
Mean Number of Short-acting Beta-agonist (SABA) Canisters Used 12 months	1.72 canisters Standard Deviation 1.86	1.82 canisters Standard Deviation 2.71

Adverse Events

Pediatric Participants Diagnosed With Asthma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adult Participants Diagnosed With Asthma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER