AsthmaSARAHNCT02270827
A Pilot Study Into Health Pre and Post Treatment With Intravenous Aminophylline and Hydrocortisone in Severe Asthmatics
An observational study of Asthma, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Aminophylline and Hydrocortisone
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe Asthmatic Adults
Who may be able to join
- Age 18-65 years
- Diagnosis of severe asthma
- Confirmed therapy adherence via serum Prednisolone and cortisol levels
Who cannot join
- Mild and moderate asthma
- Community acquired pneumonia
- Acute porphyria
- Pregnant and breast feeding women
- Patients hypersensitive to ethylenediamine or allergic to the theophyllines, caffeine and/or theorbromine.
- Patient with known hypersensitivity to components and in systemic fungal infection
- Patients that are being administered live attenuated vaccines.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Aminophylline, Hydrocortisone
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminophyllineDrug
intravenous medication
HydrocortisoneDrug
Intravenous medication
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure a significant improvement in lung function in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone
Lung function will be measured via spirometry (large airways) and impulse oscillometry (small airways) before and after treatment
Measured: Day 0 and Day 7 (+/- 3 days)
Secondary outcomes (4)
To measure a significant improvement in symptoms in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone
This will be measured by looking at symptoms via 2 questionnaires, ACQ-7, Dyspnoea-12, before and after treatment
Measured: Day 0 and Day 7 (+/- 3 days)
To measure a significant improvement in quality of life in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone
This will be measured by giving each patient the EuroQOL questionnaire before and after treatment
Measured: Day 0 and Day 7 (+/- 3 days)
To measure a significant improvement in exercise tolerance in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone
This will be measured by asking each patient to perform a 6 Minute Walk Test before and after treatment
Measured: Day 0 and Day 7 (+/- 3 days)
To measure a significant cardiovascular change in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone
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
Measured: Day 0 and Day 7 (+/- 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Study was set up by an MSc student who left her post.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Menzies-Gow, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270827
- Sponsor's protocol ID
- 2013AT001B
- Acronym
- SARAH
- Status last verified
- Oct 2015
- First submitted
- 6 Oct 2014
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Into Health Pre and Post Treatment With Intravenous Aminophylline and Hydrocortisone in Severe Asthmatics
- ClinicalTrials.gov ID
- NCT02270827
- Acronym / sponsor ID
- SARAH / 2013AT001B
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was set up by an MSc student who left her post.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe Asthmatic Adults
Key inclusion criteria (3 listed)
- Age 18-65 years
- Diagnosis of severe asthma
- Confirmed therapy adherence via serum Prednisolone and cortisol levels
Key exclusion criteria (7 listed)
- Mild and moderate asthma
- Community acquired pneumonia
- Acute porphyria
- Pregnant and breast feeding women
- Patients hypersensitive to ethylenediamine or allergic to the theophyllines, caffeine and/or theorbromine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminophyllineintravenous medication | Drug | – |
| HydrocortisoneIntravenous medication | Drug | – |
Primary outcome
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
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study was stopped early (reason given: Study was set up by an MSc student who left her post.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Menzies-Gow principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was set up by an MSc student who left her post.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.