Trial Outcomes & Findings for Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room. (NCT NCT00588406)

NCT ID: NCT00588406

Last Updated: 2016-01-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 95 participants
• Primary outcome timeframe: 4 hours post-randomization
• Results posted on: 2016-01-21

Participant Flow

Participant milestones

Measure	Budesonide Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO	Placob Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO
Overall Study STARTED	46	49
Overall Study COMPLETED	46	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.

Baseline characteristics by cohort

Measure	Budesonide n=46 Participants Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO	Placebo n=49 Participants Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO	Total n=95 Participants Total of all reporting groups
Age, Continuous	37.2 years STANDARD_DEVIATION 11.4 • n=5 Participants	42.6 years STANDARD_DEVIATION 11.4 • n=7 Participants	40 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	22 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	27 Participants n=7 Participants	44 Participants n=5 Participants
Race/Ethnicity, Customized White	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Black	28 participants n=5 Participants	18 participants n=7 Participants	46 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	12 participants n=5 Participants	20 participants n=7 Participants	32 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants
Race/Ethnicity, Customized Unknown	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	49 participants n=7 Participants	95 participants n=5 Participants
Forced expiratory volume at one second (FEV1) % predicted	29.5 percent predicted of FEV1 STANDARD_DEVIATION 9.5 • n=5 Participants	29 percent predicted of FEV1 STANDARD_DEVIATION 8.1 • n=7 Participants	29.2 percent predicted of FEV1 STANDARD_DEVIATION 8.7 • n=5 Participants

PRIMARY outcome

Timeframe: 4 hours post-randomization

Outcome measures

Measure	Budesonide n=46 Participants Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO	Placebo n=49 Participants Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO
FEV1 Percent Predicted	51.7 percent predicted of FEV1 Standard Deviation 16.8	52.6 percent predicted of FEV1 Standard Deviation 15.8

SECONDARY outcome

Timeframe: 6 hours

Outcome measures

Measure	Budesonide n=46 Participants Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO	Placebo n=49 Participants Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO
Hospitalization	39 percentage of participants	39 percentage of participants

Adverse Events

Budesonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Robert Silverman

North Shore Long Island Jewish Health System

Phone: 718-470-7501

Email: rsilverman@nshs.edu

Results disclosure agreements

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