A Pilot Study Into Health Pre and Post Treatment With Intravenous Aminophylline and Hydrocortisone in Severe Asthmatics

• Status: Terminated
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study focuses on severe asthmatics and their asthma symptoms. 40% of asthma patients continue to experience symptoms and up to 5% of these have difficult-to-control asthma despite continually improving treatments. Severe asthmatics experience clinically-significant worse health-related quality of life than those than those with less severe asthma. Poorer health-related quality of life can be as a consequence of frequent, severe symptoms, which prevent the patient from continuing a normal, active lifestyle. The Royal Brompton Hospital uses the treatment regimen of intravenous (IV) Aminophylline and IV Hydrocortisone which appears to improve symptoms and reduce exacerbations. At present there is anecdotal evidence to support these assumptions. The objective of this study is to determine whether there is any objective evidence of improvement, in particular looking at lung function, symptoms and cardiovascular function.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Treatments: Aminophylline; Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

1. Age 18-65 years

2. Diagnosis of severe asthma

3. Confirmed therapy adherence via serum Prednisolone and cortisol levels

Exclusion Criteria:

1. Mild and moderate asthma

2. Community acquired pneumonia

3. Acute porphyria

4. Pregnant and breast feeding women

5. Patients hypersensitive to ethylenediamine or allergic to the theophyllines, caffeine and/or theorbromine.

6. Patient with known hypersensitivity to components and in systemic fungal infection

7. Patients that are being administered live attenuated vaccines.