Severe Asthma Regimen of Aminophylline And Hydrocortisone (SARAH)

• Conditions: Severe asthma; MedDRA version: 16.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-000182-45-GB
• Lead Sponsor: Royal Brompton and Harefield NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-02
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age 18-65 years
2. Diagnosis of severe asthma
3. Confirmed therapy adherence via serum Prednisolone and cortisol levels

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Mild and moderate asthma
2. Community acquired pneumonia
3. Pregnant and breast feeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Is there a significant improvement lung function in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone?;Secondary Objective: Is there a significant improvement in symptom score, quality of life, cardiovascular function and exercise tolerance, with a concomitant change in inflammatory profile, in severe asthmatic patients after receiving a course of IV aminophylline and IV hydrocortisone?;Primary end point(s): The primary outcome will be lung function pre and post IV Aminophylline/IV Hydrocortisone treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Is there a significant improvement in symptoms, Quality of Life (QoL) and exercise tolerance and cardiovascular function with a concomitant change in inflammatory profile, in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone?