An interventional study of beclamethasone dipropionate and albuterol in Asthma and COPD, sponsored by State University of New York at Buffalo. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-04.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Health services research
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 6 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: albuterol · Drug: Prednisone
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.
Drug: beclamethasone dipropionate · Drug: albuterol · Drug: Prednisone
Inhaler
Also known as: Qvar
Inhaler
Also known as: Ventolin
Oral corticosteroid
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.
Time frame: 30 days
| Milestone | Standard of Care | Treatment |
|---|---|---|
| Started | 3 | 3 |
| Completed | 3 | 3 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
Collected over Enrolled patients were contacted within 72 hours of ED discharge. Subjects were asked to describe how they were taking study medications and whether or not they were experiencing any side effects of the medication.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | — | 0/3 (0%) | 0/3 (0%) |
| Treatment | — | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Standard of Care | Treatment | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 6 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Standard of Care | Treatment | Total |
|---|---|---|---|
| Median | 55 (45 to 62) | 57 (52 to 61) | 56 (45 to 62) |
| Sex: Female, Male(Participants) | Standard of Care | Treatment | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 2 | 3 | 5 |
| Region of Enrollment(participants) | Standard of Care | Treatment | Total |
|---|---|---|---|
| United States | 3 | 3 | 6 |
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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State University of New York at Buffalo