AsthmaNCT01346852

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

An observational study of Asthma, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 4 years and older
Conditions the study is for: Asthma
How many people: 101,437 participants
Where: No sites listed yet
Study dates: Jul 2009to Apr 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

Subjects with COPD or treatment for COPD

About this study

Conditions: Asthma
Being tested: Asthma treatment with an asthma-related medication and at least one asthma controller medication
Keywords: pediatrics, Medicaid, asthma, outcomes, asthma medication ratio
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01346852
Study group	Role	What they receive
Pediatric participants		Pediatric participants (age 4 to 17) with a diagnosis of asthma Receives: 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 Receives: Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population.
Measured: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Apr 2010

First posted3 May 2011 (estimated)
Study startJul 2009
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 101,437 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01346852
Sponsor's protocol ID: 112607
Status last verified: May 2017
First submitted: 15 Apr 2011
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
ClinicalTrials.gov ID: NCT01346852
Acronym / sponsor ID: 112607
Conditions: Asthma
Keywords: pediatrics, Medicaid, asthma, outcomes, asthma medication ratio
Study type: Observational
Recruitment status: Completed
Enrolment: 101,437 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 3 May 2011 (estimated)
Results: Posted 1 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Pediatric participants	–	Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medicationPediatric participants (age 4 to 17) with a diagnosis of asthma
Adult participants	–	Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medicationAdult participants (age 18 and older) with a diagnosis of asthma

Who may qualify

Ages: 4 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The study intends to identify subjects at least 4 years of age with asthma and using asthma medications

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Subjects with COPD or treatment for COPD

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Asthma treatment with an asthma-related medication and at least one asthma controller medicationparticipants 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.	Drug	Adult participants, Pediatric participants

Primary outcome

Mean Ratio of Controller Medication to Total Asthma Medication
Time frame: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
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.

1 secondary outcome

Mean Number of Short-acting Beta-agonist (SABA) Canisters Used
Time frame: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods

Results and safety

Results posted to the registry on 1 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pediatric Participants Diagnosed With Asthma	41,753	41,753
Adult Participants Diagnosed With Asthma	59,684	59,684

Primary outcome: Mean Ratio of Controller Medication to Total Asthma Medication

Time frame: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods. Mean (Standard Deviation). Unit: ratio

Measure	Pediatric Participants Diagnosed With Asthma n = 40659	Adult Participants Diagnosed With Asthma n = 59174
3 months, n=40419, 59016	0.57 (0.34)	0.66 (0.34)
6 months, n=40525, 59091	0.66 (0.26)	0.71 (0.29)
12 months, n=40659, 59174	0.63 (0.26)	0.70 (0.29)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pediatric Participants Diagnosed With Asthma	0 of 0	0 of 0	Not reported
Adult Participants Diagnosed With Asthma	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Ratio of Controller Medication to Total Asthma Medication (time frame: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01346852.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.