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Severe Asthma Regimen of Aminophylline And Hydrocortisone (SARAH)

A pilot study into health pre and post treatment with intravenous Aminophylline and Hydrocortisone in severe asthmatics - SARAH pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-000182-45-GB
Enrollment
Unknown
Registered
2014-04-02
Start date
2014-04-02
Completion date
Unknown
Last updated
2015-07-10

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

Conditions

Severe asthma MedDRA version: 16.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Solu-Cortef® (Hydrocortisone sodium succinate) Product Name: Solu-Cortef 100mg (Hydrocortisone sodium succinate for injection BP 100mg) Pharmaceutical Form: INN or Proposed INN: Hydrocor

Sponsors

Royal Brompton and Harefield NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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?—

Countries

United Kingdom

Contacts

Public ContactIra Jakupovic

Royal Brompton and Harefield NHS Foundation Trust

i.jakupovic@rbht.nhs.uk02073518109

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026