Trial Outcomes & Findings for Prednisolone Pharmacokinetics in Severe Asthma (NCT NCT00662298)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

2h, 6h, 24h

Results posted on

2019-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Severe Asthma prednisolone: 40mg of prednisolone once a day for 14 days
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Severe Asthma n=5 Participants prednisolone: 40mg of prednisolone once a day for 14 days
Age, Continuous	52.2 years STANDARD_DEVIATION 2.87 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United Kingdom	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 2h, 6h, 24h

Outcome measures

Outcome measures
Measure	Severe Asthma n=5 Participants prednisolone: 40mg of prednisolone once a day for 14 days
Serum Prednisolone Levels Over 24 Hours 2h	800 nmol/l Standard Deviation 600
Serum Prednisolone Levels Over 24 Hours 6h	700 nmol/l Standard Deviation 500
Serum Prednisolone Levels Over 24 Hours 24h	NA nmol/l Standard Deviation NA NA (Not Available), below level of detection

PRIMARY outcome

Timeframe: 14 days

Population: No data collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 14 days

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 14 days

Outcome measures

Outcome measures
Measure	Severe Asthma n=5 Participants prednisolone: 40mg of prednisolone once a day for 14 days
Difference Between Baseline and Day 14 in Serum Prednisolone Levels baseline	2.0 nmol/litres Interval 1.45 to 2.73
Difference Between Baseline and Day 14 in Serum Prednisolone Levels 14days	2.11 nmol/litres Interval 1.61 to 2.82

SECONDARY outcome

Timeframe: 14 days

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Population: Data were not collected.

Outcome measures

Outcome data not reported

Adverse Events

Severe Asthma

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

Professor Fan Chung

Imperial College London

Phone: 00442075947954

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place