Comparison of recovery of adrenal gland function following short and long term steroid treatment

• Register: EUCTR
• Last refreshed on: 28 August 2012
• Main ID: EUCTR2011-005790-23-GB
• Date of registration: 06/06/2012
• Prospective Registration: Yes
• Primary sponsor: Birmingham Children's Hospital NHS Foundation Trust
• Public title: Comparison of recovery of adrenal gland function following short and long term steroid treatment
• Scientific title: Comparison of adrenal recovery following short and long-term glucocorticoid therapy. - Adrenal recovery following short and long-term glucocorticoid therapy
• Date of first enrolment: 17/07/2012
• Target sample size: 60
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005790-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
The inclusion criteria for the two categories include.

Short-term Glucocorticosteroid tratment group: Patients with newly diagnosed Acute Lymoblastic Leukemia (above 1 year of age) presenting to Birmingham Children’s Hospital, receiving high dose dexamethasone for <8 weeks.
Long-term Glucocorticosteroid tratment group: Patients between 1-17 years of age with chronic lung, liver or rheumatological disorders requiring long-term (>8 weeks) Glucocorticosteroid (GC) therapy

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
Exclusion criteria for short and long term GC groups include,
GC use for any other underlying conditions including use of topical or inhaled steroids.

Unwilling, or unable to give informed consent



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Physiological processes [G07]

Adrenal recovery following long and short term steroid treatment.
MedDRA version: 14.1 Level: LLT Classification code 10066550 Term: Chronic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1 Level: LLT Classification code 10000842 Term: Acute lymphatic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1 Level: LLT Classification code 10008953 Term: Chronic liver disease System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 14.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders

Intervention(s)

Product Name: Prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 53-03-2
Current Sponsor code: N/A
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 2.5-

Product Name: Hydrocortisone
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydrocortisone
CAS Number: 50-23-7
Current Sponsor code: N/A
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 5-10

Primary Outcome(s)

Primary end point(s): The primary endpoint is adrenal recovery, as defined by the time taken for the adrenals to recover (peak 30min cortisol >550nmol/L) following short or long term corticosteroid therapy, i.e from the last GC dose to the first normal ACTH test.

For comparison of categorical data between the short- and long-term GC group, and between the two GC weaning groups, Chi-square and Fisher’s exact tests are used, giving binomial confidence intervals for % recovering at each time point.

Main Objective: The primary research question is to compare how quickly the adrenal glands take to recover following short term (4 weeks) or long term (more than 2 months) steroid treatment.

Secondary Objective: The secondary research question in the long term steroid users is whether there is a difference in adrenal recovery time in children on two different types of steroid medications.

Timepoint(s) of evaluation of this end point: Time points after last GC dose: day 7±1, day 14±1, day 21±1 and day 35±1. First normal synacthen test ends the study participation, i.e. if synacthen test is normal already on day 7±1, no further testing at other time points.
Adrenal recovery is defined as the time taken for the adrenals to recover (peak 30min cortisol >550nmol/L) following short or long term corticosteroid therapy, i.e from the last GC dose to the first normal ACTH test.

Secondary Outcome(s)

Secondary end point(s): A self-administered questionnaire to be completed by the patient or parent on each visit, evaluating the symptoms and signs of steroid withdrawal syndrome

Timepoint(s) of evaluation of this end point: Frequency of signs/symptoms of the steroid withdrawal syndrome and the peak cortisol in nmol/l at which this occurs at day 7±1, day 14±1, day 21±1 and day 35±1 after last GC dose.

Secondary ID(s)

N/A