AsthmaNCT01332357

Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit

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 objective of this study is to compare readmission to the emergency department for asthma in asthma patients who receive treatment with fluticasone propionate and salmeterol oral inhaler after an initial emergency department visit using a retrospective observational cohort study design. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: Fluticasone propionate/salmeterol combination ED MD and Fluticasone propionate/salmeterol combination OP MD
How many people: 6,139 participants
Where: No sites listed yet
Study dates: Jun 2009to Jul 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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The study intends to identify subjects with asthma discharged from an emergency department that received fluticasone propionate/salmeterol from either an ED physician or from an outpatient physician

Who may be able to join

Subjects with asthma as determined by ICD-9 codes and asthma drug use
at least 12 years of age
discharged from an initial Emergency Department visit within 12 months

Who cannot join

Subjects with COPD or treatment for COPD

About this study

Conditions: Asthma
Being tested: Fluticasone propionate/salmeterol combination ED MD, Fluticasone propionate/salmeterol combination OP MD
Keywords: fluticasone/propionate salmeterol combination, hospitalization, emergency department, asthma
Medical subject headings: Asthma, Emergencies

What participants receive

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

Fluticasone propionate/salmeterol combination ED MDDrug
Receipt of fluticasone propionate/salmeterol combination from the ED physician
Fluticasone propionate/salmeterol combination OP MDDrug
Receipt of fluticasone propionate/salmeterol combination from the OP physician

Study groups in NCT01332357
Study group	Role	What they receive
Fluticasone propionate/salmeterol combination ED MD		Asthma subjects discharged from an institution after treatment for severe asthma exacerbation that receive fluticasone propionate/salmeterol combination from the ED physician Receives: Drug: Fluticasone propionate/salmeterol combination ED MD
Fluticasone propionate/salmeterol combination OP MD		Asthma subjects discharged from an institution after treatment for severe asthma exacerbation that receive fluticasone propionate/salmeterol combination from the OP physician Receives: Drug: Fluticasone propionate/salmeterol combination OP MD

What is being measured

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

Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event
A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.
Measured: Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.

Timeline

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

Jun 2009Jul 2010

First posted11 Apr 2011 (estimated)
Study startJun 2009
Primary completionJul 2010
Study completionJul 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: 6,139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01332357
Sponsor's protocol ID: 112606
Status last verified: Jun 2017
First submitted: 7 Apr 2011
Last updated: 6 Jul 2017
Results posted: Yes, on ClinicalTrials.gov

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 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit
ClinicalTrials.gov ID: NCT01332357
Acronym / sponsor ID: 112606
Conditions: Asthma
Keywords: fluticasone/propionate salmeterol combination, hospitalization, emergency department, asthma
Study type: Observational
Recruitment status: Completed
Enrolment: 6,139 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 11 Apr 2011 (estimated)
Results: Posted 13 Oct 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
Fluticasone propionate/salmeterol combination ED MD	–	Drug: Fluticasone propionate/salmeterol combination ED MDAsthma subjects discharged from an institution after treatment for severe asthma exacerbation that receive fluticasone propionate/salmeterol combination from the ED physician
Fluticasone propionate/salmeterol combination OP MD	–	Drug: Fluticasone propionate/salmeterol combination OP MDAsthma subjects discharged from an institution after treatment for severe asthma exacerbation that receive fluticasone propionate/salmeterol combination from the OP physician

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The study intends to identify subjects with asthma discharged from an emergency department that received fluticasone propionate/salmeterol from either an ED physician or from an outpatient physician

Key inclusion criteria (3 listed)

Subjects with asthma as determined by ICD-9 codes and asthma drug use
at least 12 years of age
discharged from an initial Emergency Department visit within 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
Fluticasone propionate/salmeterol combination ED MDReceipt of fluticasone propionate/salmeterol combination from the ED physician	Drug	Fluticasone propionate/salmeterol combination ED MD
Fluticasone propionate/salmeterol combination OP MDReceipt of fluticasone propionate/salmeterol combination from the OP physician	Drug	Fluticasone propionate/salmeterol combination OP MD

Primary outcome

Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event
Time frame: Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.
A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.

Results and safety

Results posted to the registry on 13 Oct 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
Total Population	6,139	6,139

Primary outcome: Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event

Time frame: Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.. Number. Unit: participants

Measure	Total Population n = 6139
Value	915

Total Population: Hazard Ratio (HR): 1.96 (95% CI 1.56 to 2.46), p <0.0001, Regression, Cox
Total Population: Hazard Ratio (HR): 1.79 (95% CI 1.42 to 2.25), p <0.0001, Regression, Cox
Total Population: Hazard Ratio (HR): 1.008 (95% CI 1.005 to 1.011), p <0.0001, Regression, Cox

Population analysed: Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total Population	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 6 Jul 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 6 Jul 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 13 Oct 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?

Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event (time frame: Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.). 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 NCT01332357.

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 6 Jul 2017.