The aim of this study was to assess the effects of high dose inhalational steroids on hypopituitary adrenal axis. 62 moderate asthmatic patients aged 15-65 years and without history of smoking, occupational asthma or history of systemic steroid consumption within the last 6 months were divided in two equal groups of 31 patients to receive Beclomethasone forte, 250 microgram, 6 puffs per day (1500 microgam/day) or Fluticasone 250 microgram, 6 puffs per day (1500 microgram/day). Patients who received Beclomethasone or Fluticasone previously entered to the same group. Fasting Blood sugar (FBS), spirometry and serum cortisol levels at 0, 30, and 60 minutes following ACTH stimulation injection were measured in all patients. Patients continued to receive previous asthma medications without changing the dose except for steroid MDI dose increased to 2 puffs three times daily for three weeks using spacer. FBS, spirometry and cortisol levels at 0, 30, and 60 minutes following ACTH stimulation test were measured at the first day and after three weeks. If the patient consumed systemic steroid or did not folow advised dose during three weeks, was excluded from the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138712121731N1
Registration date:2009-07-22, 1388/04/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-07-22, 1388/04/31
Registrant information
Name
Keivan Gohari Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2250 7698
Email address
kgohari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrine and Metabolism Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2009-04-09, 1388/01/20
Expected recruitment end date
2010-07-11, 1389/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of inhalational steroids on hypopituitary adrenal gland
Public title
Effects of High dose Fluticasone and Beclomethasone on hypopituitary adrenal axis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of moderate asthma
Exclusion criteria: cigarette smoking, occupational asthma, history of systemic steroid use during the last 6 months, low compliance for 1500 microgram MDI use, consumption of systemic steroid during the study
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
ACTH stimulation test and measurement of serum cortisol levels following it and increased steroid MDI dose and repeat stimulation test and cortisol measurement are the features of the study which is much more precise for adequacy of adrenal-hypopituitary axis.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Endocrine Research Center
Street address
Shariati Hospital
City
Tehran
Postal code
1411413137
Approval date
empty
Ethics committee reference number
E0026
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Serum cortisol levels
Timepoint
0, 30, and 60 min. after ACTH in ther 1st and last session after (3 weeks)
Method of measurement
Serum Cortisol levels
Secondary outcomes
1
Description
FBS
Timepoint
First and 3 weeks 3 after increased MDI dose
Method of measurement
Serum glucose fasting level
2
Description
Spirometric values
Timepoint
3 weeks later
Method of measurement
Spirometry
Intervention groups
1
Description
Beclomethasone 250 microgram MDI to 6 puffs /d ( 1500 microgram ) for 3 weeks by spacer.
Category
Treatment - Drugs
2
Description
Fluticasone MDI 250 microgram to 6 puffs/d ( 1500 microgram ) for 3 weeks by spacer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital, Tehran University of Medical Sciences
Full name of responsible person
Keivan Gohari Moghadam
Street address
Shariati Hospital, North Kargar Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrine Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Heshmat
Street address
Shariati Hospital
City
Tehran
Grant name
Grant code / Reference number
P.M .8611/82
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrine Research Center, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Faculty of Medicine , Shariati hospital
Full name of responsible person
Keivan Gohari Moghadam
Position
Assistant professor
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
1411413137
Phone
+98 21 2290 0008
Fax
+98 212276951
Email
kgohari@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Keivan Gohari Moghadam
Position
Assistant professor
Other areas of specialty/work
Street address
Shariati hospital
City
Tehran
Postal code
1411432583
Phone
+98 21 2250 7698
Fax
+98 21 2227 6951
Email
kgohari@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Keivan Gohari Moghadam
Position
Assistant professor
Other areas of specialty/work
Street address
Shariati hospital
City
Tehran
Postal code
1411413137
Phone
+98 21 2250 7698
Fax
+98 21 2227 6951
Email
kgohari@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)