Repeat Emergency Department Visits Among Patients With Asthma and COPD

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02499887
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Asthma; COPD	Drug: beclamethasone dipropionate; Drug: albuterol; Drug: Prednisone	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Repeat Emergency Department Visits Among Patients With Asthma and COPD
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care 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; Inhaler; Other Names: Ventolin ; Drug: Prednisone; Oral corticosteroid
Experimental: Treatment 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; Inhaler; Other Names: Qvar ; Drug: albuterol; Inhaler; Other Names: Ventolin ; Drug: Prednisone; Oral corticosteroid

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erie County Medical Center	Buffalo	New York	United States	14215

Sponsors and Collaborators

• State University of New York at Buffalo

Investigators

• Principal Investigator: Heather A Lindstrom, PhD, University at Buffalo, Department of Emergency Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heather Lindstrom, Research Assistant Professor, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT02499887
• Other Study ID Numbers: 754754
• First Posted: Jul 16, 2015
• Last Update Posted: Jun 4, 2019
• Last Verified: Jun 1, 2019

• Additional relevant MeSH terms: Asthma; Emergencies; Prednisone; Albuterol

Study Results

Participant Flow

Arm/Group Title	Standard of Care	Treatment
Arm/Group Description	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. albuterol: Inhaler Prednisone: Oral corticosteroid	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. beclamethasone dipropionate: Inhaler albuterol: Inhaler Prednisone: Oral corticosteroid
Period Title: Overall Study
STARTED	3	3
COMPLETED	3	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Standard of Care	Treatment	Total
Arm/Group Description	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. albuterol: Inhaler Prednisone: Oral corticosteroid	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. beclamethasone dipropionate: Inhaler albuterol: Inhaler Prednisone: Oral corticosteroid	Total of all reporting groups
Overall Participants	3	3	6
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	3 100%	6 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	55	57	56
Sex: Female, Male (Count of Participants)
Female	1 33.3%	0 0%	1 16.7%
Male	2 66.7%	3 100%	5 83.3%
Region of Enrollment (participants) [Number]
United States	3 100%	3 100%	6 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge
Description	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

Outcome Measure Data

Analysis Population Description

Study was discontinued due to low enrollment. No 30 day return visit data was collected.

Arm/Group Title	Standard of Care	Treatment
Arm/Group Description	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. albuterol: Inhaler Prednisone: Oral corticosteroid	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. beclamethasone dipropionate: Inhaler albuterol: Inhaler Prednisone: Oral corticosteroid
Measure Participants	0	0

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	Adverse event description does not differ.
Arm/Group Title	Standard of Care		Treatment
Arm/Group Description	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. albuterol: Inhaler Prednisone: Oral corticosteroid		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. beclamethasone dipropionate: Inhaler albuterol: Inhaler Prednisone: Oral corticosteroid
All Cause Mortality
	Standard of Care		Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard of Care		Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care		Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.