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Trial Outcomes & Findings for Repeat Emergency Department Visits Among Patients With Asthma and COPD (NCT NCT02499887)

NCT ID: NCT02499887

Last Updated: 2019-06-04

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

30 days

Results posted on

2019-06-04

Participant Flow

Participant milestones

Participant milestones
Measure
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. albuterol: Inhaler Prednisone: Oral corticosteroid
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. beclamethasone dipropionate: Inhaler albuterol: Inhaler Prednisone: Oral corticosteroid
Overall Study
STARTED
3
3
Overall Study
COMPLETED
3
3
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Information on age of all subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard of Care
n=3 Participants
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
n=3 Participants
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
n=6 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants • Information on age of all subjects
0 Participants
n=7 Participants • Information on age of all subjects
0 Participants
n=5 Participants • Information on age of all subjects
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants • Information on age of all subjects
3 Participants
n=7 Participants • Information on age of all subjects
6 Participants
n=5 Participants • Information on age of all subjects
Age, Categorical
>=65 years
0 Participants
n=5 Participants • Information on age of all subjects
0 Participants
n=7 Participants • Information on age of all subjects
0 Participants
n=5 Participants • Information on age of all subjects
Age, Continuous
55 years
n=5 Participants • Information on age of all subjects
57 years
n=7 Participants • Information on age of all subjects
56 years
n=5 Participants • Information on age of all subjects
Sex: Female, Male
Female
1 Participants
n=5 Participants • Sex of all enrolled subjects
0 Participants
n=7 Participants • Sex of all enrolled subjects
1 Participants
n=5 Participants • Sex of all enrolled subjects
Sex: Female, Male
Male
2 Participants
n=5 Participants • Sex of all enrolled subjects
3 Participants
n=7 Participants • Sex of all enrolled subjects
5 Participants
n=5 Participants • Sex of all enrolled subjects
Region of Enrollment
United States
3 participants
n=5 Participants
3 participants
n=7 Participants
6 participants
n=5 Participants

PRIMARY outcome

Timeframe: 30 days

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

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.

Outcome measures

Outcome data not reported

Adverse Events

Standard of Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather Lindstrom

UBMD Emergency Medicine

Phone: 716-898-4564

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place