AsthmaNCT02499887
Repeat Emergency Department Visits Among Patients With Asthma and COPD
A study testing beclamethasone dipropionate, albuterol and Prednisone in people with Asthma and COPD, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of the proposed study is to determine whether the addition of inhaled corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat emergency department (ED) visits among patients treated for acute exacerbations of asthma and COPD discharged from the emergency department to home. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- beclamethasone dipropionate, albuterol and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Sep 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated in the ED at the Erie County Medical Center (ECMC) for acute symptoms of asthma or COPD during the study period
- Patient age ≥ 18 years
- Resident of the City of Buffalo or Erie County
- Discharged to home
- Patient expresses willingness to return to ECMC or own primary care provider for follow-up visits
- Able to provide informed consent
- Able to comprehend English language
Who cannot join
- Received oral or inhaled corticosteroids in the week before ED presentation
- Presented to the ED primarily for prescription refills
- Complicated comorbid conditions (e.g. renal disease, cardiovascular disease, CHF, HIV)
- Admitted to ECMC or discharged to another facility
- Previously enrolled during a prior visit to the ED during the study period
- For female patients--pregnant or pregnancy status indeterminate
- Antibiotics are prescribed to treat current asthma/COPD exacerbation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the proposed study is to determine whether the addition of inhaled corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat emergency department (ED) visits among patients treated for acute exacerbations of asthma and COPD discharged from the emergency department to home. The investigators hypothesize that patients treated with inhaled corticosteroids in addition to oral corticosteroids and albuterol will have lower rates of 30-day return visits to the emergency department than those patients treated with oral corticosteroids and albuterol only.
- Being tested
- beclamethasone dipropionate, albuterol, Prednisone
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclamethasone dipropionateDrug
Also called Qvar
Inhaler
albuterolDrug
Also called Ventolin
Inhaler
PrednisoneDrug
Oral corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED)
Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications. Receives: Drug: albuterol; Drug: Prednisone |
| Treatment | Experimental | Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days
Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications. Receives: Drug: beclamethasone dipropionate; Drug: albuterol; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge
Subjects' medical records will be reviewed for the 30 day period following ED discharge to determine if they return to the treating ED or another regional ED for treatment of an acute asthma/COPD exacerbation. Regional ED records will be queried by use of data maintained by HEALTHeLINK, our regional health information organization system. This will allow for more complete capture of ED return visits that could be obtained by looking only at a single ED.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Exclusion criteria prevented enrollment of adequate # of participants
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 State University of New York at BuffaloThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Lindstrom, State University of New York at Buffalo
- Investigators
- Heather A Lindstrom, PhD, Principal investigator, University at Buffalo, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499887
- Sponsor's protocol ID
- 754754
- Status last verified
- Jun 2019
- First submitted
- 10 Jul 2015
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeat Emergency Department Visits Among Patients With Asthma and COPD
- ClinicalTrials.gov ID
- NCT02499887
- Acronym / sponsor ID
- 754754
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Exclusion criteria prevented enrollment of adequate # of participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed study is to determine whether the addition of inhaled corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat emergency department (ED) visits among patients treated for acute exacerbations of asthma and COPD discharged from the emergency department to home. The investigators hypothesize that patients treated with inhaled corticosteroids in addition to oral corticosteroids and albuterol will have lower rates of 30-day return visits to the emergency department than those patients treated with oral corticosteroids and albuterol only.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: albuterol, Drug: PrednisoneStandard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED) Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications. |
| Treatment | Experimental | Drug: beclamethasone dipropionate, Drug: albuterol, Drug: PrednisoneTreatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Treated in the ED at the Erie County Medical Center (ECMC) for acute symptoms of asthma or COPD during the study period
- Patient age ≥ 18 years
- Resident of the City of Buffalo or Erie County
- Discharged to home
- Patient expresses willingness to return to ECMC or own primary care provider for follow-up visits
Key exclusion criteria (7 listed)
- Received oral or inhaled corticosteroids in the week before ED presentation
- Presented to the ED primarily for prescription refills
- Complicated comorbid conditions (e.g. renal disease, cardiovascular disease, CHF, HIV)
- Admitted to ECMC or discharged to another facility
- Previously enrolled during a prior visit to the ED during the study period
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 |
|---|---|---|
| beclamethasone dipropionateAlso: QvarInhaler | Drug | Treatment |
| albuterolAlso: VentolinInhaler | Drug | Standard of Care, Treatment |
| PrednisoneOral corticosteroid | Drug | Standard of Care, Treatment |
Primary outcome
Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge
Time frame: 30 days
Subjects' medical records will be reviewed for the 30 day period following ED discharge to determine if they return to the treating ED or another regional ED for treatment of an acute asthma/COPD exacerbation. Regional ED records will be queried by use of data maintained by HEALTHeLINK, our regional health information organization system. This will allow for more complete capture of ED return visits that could be obtained by looking only at a single ED.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- 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.
Heather A Lindstrom, PhD principal investigator
University at Buffalo, Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beclamethasone dipropionate, albuterol and Prednisone in people with Asthma and COPD, run by State University of New York at Buffalo at 1 site in United States.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 Jun 2019). 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?
Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2019.