Corticosteroids in Asthma

Randomised, placebo controlled trial investigating adverse effects of Oral Corticosteroids in adults with stable asthma

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000562976

Acronym

CIA

Enrollment

Registered

2011-06-01

Start date

2011-11-01

Completion date

2013-04-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There is some evidence to suggest that oral corticosteroid medications may increase appetite and lead to weight gain. However it is unknown whether people with asthma experience these effects when prescribed oral corticosteroids when their asthma symptoms worsen. This study is designed to examine whether taking oral corticosteroids for a short time affects appetite, dietary intake, body weight or body composition and bone metabolism.

Interventions

Adults with stable asthma will be randomised to receive a 10 day course of either 1 x Prednisolone 25mg oral capsule twice daily or 1 x placebo oral capsule twice daily and after a 6 week wash out period subjects will begin a 10 day course of the alternate treatment.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adults with stable asthma not currently taking oral corticosteroid medication or other medications known to interact with them. No asthma exacerbation, respiratory tract infection or oral corticosteroids in the previous 4 weeks.

Exclusion criteria

Under 18 years old, diabetes mellitus.

Outcome results