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

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ClinicalTrials.gov Identifier: NCT02270827
Recruitment Status : Terminated (Study was set up by an MSc student who left her post.)
First Posted : October 21, 2014
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment
Asthma Drug: Aminophylline Drug: Hydrocortisone

Detailed Description:

The participant will be involved in this project for approximately 3 - 4 weeks, depending on how long they usually come into hospital for, for clinical treatment. For 1 week they will wear a physical activity monitor before the first course of Aminophylline and Hydrocortisone, during the treatment, and for 1 more week post treatment. This monitor records how active the participants are and is a small monitor worn on the upper arm.

Both study visits will happen while the patients are already in hospital, on admission and on discharge and will take approximately 2-3 hours to complete.

Both study visits include:

• 3 types of breathing tests: Impulse oscillometry in the asthma laboratory, which means they will breath through a mouth piece in and out at a comfortable, steady rate.

Exhaled nitric oxide which measures gas produced by cells in the lungs. This is a comfortable, steady blow into a handheld machine.

Spirometry which involves filling the lungs and blowing out hard into a machine.

  • A blood test - Full Blood Count (FBC) including eosinophils, glucose, fibrinogen, C-Reactive Protein (CRP), total Immunoglobulin-E (IgE), citrate coagulation and platelet aggregation.
  • 3 short questionnaires which ask about symptoms, control of asthma, and how the patient feels asthma affects them.
  • A 6 Minute Walk Test which involves walking up and down a ward corridor for 6 minutes to see distance covered in 6 minutes.
  • Cardiovascular test:

Arterial stiffness which is a series of blood pressures on the leg, arm and neck.

Some of these tests will be performed as part of their usual hospital care. These include blood test, 6 Minute Walk Test, and spirometry.

Blood samples will be done routinely as part of normal care. Blood will only be collected if they do not have a clinical blood test before the administration of IV Aminophylline and IV Hydrocortisone and after the final dose. The clinical trial is observing patients on a clinical treatment. All decisions regarding the treatment dose and duration will be made by the clinical team. All samples will go to the standard accredited hospital routine laboratory on the trial site. No samples will be stored, moved off site or leave the UK.


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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study Into Health Pre and Post Treatment With Intravenous Aminophylline and Hydrocortisone in Severe Asthmatics
Study Start Date : June 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015



Intervention Details:
  • Drug: Aminophylline
    intravenous medication
  • Drug: Hydrocortisone
    Intravenous medication


Primary Outcome Measures :
  1. To measure a significant improvement in lung function in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone [ Time Frame: Day 0 and Day 7 (+/- 3 days) ]
    Lung function will be measured via spirometry (large airways) and impulse oscillometry (small airways) before and after treatment


Secondary Outcome Measures :
  1. To measure a significant improvement in symptoms in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone [ Time Frame: Day 0 and Day 7 (+/- 3 days) ]
    This will be measured by looking at symptoms via 2 questionnaires, ACQ-7, Dyspnoea-12, before and after treatment

  2. To measure a significant improvement in quality of life in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone [ Time Frame: Day 0 and Day 7 (+/- 3 days) ]
    This will be measured by giving each patient the EuroQOL questionnaire before and after treatment

  3. To measure a significant improvement in exercise tolerance in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone [ Time Frame: Day 0 and Day 7 (+/- 3 days) ]
    This will be measured by asking each patient to perform a 6 Minute Walk Test before and after treatment

  4. To measure a significant cardiovascular change in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone [ Time Frame: Day 0 and Day 7 (+/- 3 days) ]
    This will be measured by performing Arterial Stiffness on each patient which involves measuring a series of blood pressures on the carotid, femoral and brachial arteries before and after treatment



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe Asthmatic Adults
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270827


Locations
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United Kingdom
Royal Brompton Hospital
London, United Kingdom, sw3 6hp
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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Principal Investigator: Andrew Menzies-Gow Royal Brompton & Harefield NHS Foundation Trust

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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02270827     History of Changes
Other Study ID Numbers: 2013AT001B
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Aminophylline
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents