Gabapentin In The Treatment Of Idiopathic Chronic Cough: A Randomised Double-blind Placebo-controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$331,229.00
Summary
Better treatment approaches are needed to address the significant quality of life impairment associated with chronic cough. We propose to conduct a double-blind, placebo controlled study comparing the efficacy (and safety) of oral gabapentin therapy on cough reflex severity and cough-specific quality of life in people with idiopathic cough. The advantages are a strong design, use of objective assessment techniques, and investigation of a new treatment modality for cough.
The AMAZES Study: Asthma And Macrolides: The AZithromycin Efficacy And Safety Study
Funder
National Health and Medical Research Council
Funding Amount
$3,157,566.00
Summary
Asthma is a health priority for Australia where better and new treatment approaches are needed. This project tests the benefit of a common antibiotic for use in asthma. We propose to conduct a large-scale, multicentre, double-blind, placebo controlled study comparing the efficacy (and safety) of the addition of oral low dose azithromycin to maintenance asthma therapy on the incidence of asthma exacerbations and clinical asthma status in participants with asthma.
A Randomised, Placebo-controlled Trial Of Erythropoietin In ICU Patients With Traumatic Brain Injury
Funder
National Health and Medical Research Council
Funding Amount
$1,950,735.00
Summary
Patients who suffer a moderate or severe head injury (traumatic brain injury) have a 50% chance of having a long term neurological disability or death. Erythropoietin is a medication which encourages red blood cell formation but its other beneficial effects are likely to improve outcomes after traumatic brain injury. This study will examine the safety and effects of erythropoietin on long term neurological function in patients who have suffered a traumatic brain injury.
Parent Initiated Oral Prednisolone For Acute Asthma In Children Aged 5-11 Years: Randomised Controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$139,250.00
Summary
The objective of this trial is to determine whether parents should commence prednisolone (a steroid anti-inflammatory drug) for an asthma attack in their child without waiting to see a doctor first. This strategy could be described as parent initiated prednisolone in asthma (PIPA). PIPA is an important consideration in every child's asthma management plan, but because of a lack of research evidence the role of PIPA is not clarified in any of the international asthma guidelines. Hence prednisolon ....The objective of this trial is to determine whether parents should commence prednisolone (a steroid anti-inflammatory drug) for an asthma attack in their child without waiting to see a doctor first. This strategy could be described as parent initiated prednisolone in asthma (PIPA). PIPA is an important consideration in every child's asthma management plan, but because of a lack of research evidence the role of PIPA is not clarified in any of the international asthma guidelines. Hence prednisolone is rarely commenced without waiting for a preceding medical review. PIPA has the potential to significantly reduce the health and economic burden of the disease by increasing the proportion of asthma exacerbations managed at home rather than in the emergency department or hospital. Prednisolone has been shown to be an effective drug when it is given to children with an asthma attack that is severe enough for them to attend hospital. Whilst it would seem logical that PIPA should be an effective strategy it is important to recognise that mild attacks are far more common than severe ones, and the promotion of PIPA as standard practice would be associated with a significant increase in the frequency prednisolone administration. As such it is important to determine if prednisolone is safe and effective when commenced in the home setting. The PIPA trial has many unique features: It is community based, where the vast majority of asthmatic children are managed. The eligibility criteria and dosing schedule have been chosen to mimic 'real world' management and it will be easy for clinicians and families to interpret and apply the results. A very large number of children will be involved (308) which has been made feasible by the trial setting and recruitment methods. Furthermore the protocol has been designed in accordance with the highest standards specified by the international research community and has been submitted to 'The Lancet' for pre-trial publication.Read moreRead less
Plasma Exchange And Glucocorticoids In ANCA Associated Vasculitis: A Randomised Controlled Trial (PEXIVAS Australia)
Funder
National Health and Medical Research Council
Funding Amount
$635,243.00
Summary
Vasculitis is a life-threatening disease, and the current treatment for this condition is not satisfactory. This clinical trial aims to determine 1) if plasma exchange can lower mortality and the development of severe kidney failure due to this disease, and 2) if the use of lower doses of corticosteroids can lessen the infectious complications of treatment. This trial is part of a major international effort which will involve a total of 500 patients from Australia, UK, Europe, USA and NZ.
Randomised Controlled Trials Of Laparoscopic Techniques For Antireflux Surgery
Funder
National Health and Medical Research Council
Funding Amount
$275,923.00
Summary
Gastro-oesophageal reflux is common, and over the last decade there has been an exponential rise in the usage of acid suppressing medication. Current trends suggest that the national cost of medical treatment of reflux will become unaffordable unless new management or preventative strategies can be developed. Presently, surgery is the only treatment which can cure reflux. Laparoscopic fundoplication has recently become an acceptable, low morbidity keyhole surgical treatment for this problem. How ....Gastro-oesophageal reflux is common, and over the last decade there has been an exponential rise in the usage of acid suppressing medication. Current trends suggest that the national cost of medical treatment of reflux will become unaffordable unless new management or preventative strategies can be developed. Presently, surgery is the only treatment which can cure reflux. Laparoscopic fundoplication has recently become an acceptable, low morbidity keyhole surgical treatment for this problem. However, research is essential to develop a procedure which optimizes the outcome for patients undergoing surgical management of reflux, and minimizes the risk of complications. This may provide a better alternative to long term management with acid suppressing medication, and could eventually achieve long term savings to the nation's health budget. Since 1994 research conducted at the Royal Adelaide Hospital has evaluated a range of different key hole operations aimed at improving the outcome for patients undergoing surgery for gastro-oesophageal reflux. Over 100 patients have been entered into each of the following clinical trials: total fundoplication with or without division of the short gastric vessels, total versus anterior partial fundoplication and posterior or anterior hiatal repair. Further trials will compare a lesser degree of anterior partial fundoplication with total fundoplication. A common research protocol has been developed and applied to all of these trials. This involves the use of double blind randomised methodology, with independent follow-up obtained by an independent investigator. These trials will determine the best surgical technique for the surgical correction of reflux, and this should lead to a more widely accepted surgical alternative to existing non-operative strategies for pathological reflux.Read moreRead less
Randomised Controlled Trial Of Stretching For Contracture After Ankle Fracture
Funder
National Health and Medical Research Council
Funding Amount
$55,220.00
Summary
Restricted ankle motion (contracture) commonly occurs after cast immobilisation following ankle fracture. The prevalence of contracture could be as high as 77% immediately following cast removal. This interferes with tasks such as walking and stair climbing, and can result in significant disability. While physiotherapists regularly treat contracture after ankle fracture, the efficacy of specific treatment programs has not been established. This project aims to determine the effectiveness of two ....Restricted ankle motion (contracture) commonly occurs after cast immobilisation following ankle fracture. The prevalence of contracture could be as high as 77% immediately following cast removal. This interferes with tasks such as walking and stair climbing, and can result in significant disability. While physiotherapists regularly treat contracture after ankle fracture, the efficacy of specific treatment programs has not been established. This project aims to determine the effectiveness of two commonly used stretching programs for contracture after ankle fracture initially treated with cast immobilisation. Stretches of short and long duration will be compared to a no stretch condition. The study will determine the effects of these interventions on ankle flexibility, ability to perform everyday tasks (eg, walking), self-ratings of disability and pain.Read moreRead less
The MASTER Anaesthesia Trial (or Mulcentre Australian Study of Epidural Anaesthesia) is a large clinical experiment designed to determine whether using epidural techniques to control pain during and after surgery results in fewer complications after major surgery. The Trial involves a comparison of epidural methods, in which some of the anaesthetic and pain-killing drugs are injected into the space in the spinal column surrounding the sac that encloses the spinal cord, with conventional methods, ....The MASTER Anaesthesia Trial (or Mulcentre Australian Study of Epidural Anaesthesia) is a large clinical experiment designed to determine whether using epidural techniques to control pain during and after surgery results in fewer complications after major surgery. The Trial involves a comparison of epidural methods, in which some of the anaesthetic and pain-killing drugs are injected into the space in the spinal column surrounding the sac that encloses the spinal cord, with conventional methods, where the drugs are injected into a vein or muscle. Both approaches are well accepted in clinical practice, but it remains uncertain whether one is superior to the other. At present, nineteen hospitals in Australia, Hong Kong and Malaysia are contributing patients to the project, with others in New Zealand and Asia expected to join soon. If one method of anaesthesia and pain control is found to be significantly better than the other, in terms of avoiding complications, this would have obvious benefits to patients, but would also reduce lengths of stay in hospital and improve efficiency within the health system.Read moreRead less
Prevention Of Pre-term Birth By Treatment Of Periodontal Disease During Pregnancy
Funder
National Health and Medical Research Council
Funding Amount
$910,125.00
Summary
Premature birth is one of the major unsolved problems in human health and is the single greatest problem in reproduction. Decades of research that has focused on features of women's lives and their pregnancies have failed to impact on the frequency of this disorder. However, there now is exciting evidence that many cases of premature labour may result from inflammation arising from a source outside the uterus. The gums are considered a likely source of that inflammation. Inflammation of the gums ....Premature birth is one of the major unsolved problems in human health and is the single greatest problem in reproduction. Decades of research that has focused on features of women's lives and their pregnancies have failed to impact on the frequency of this disorder. However, there now is exciting evidence that many cases of premature labour may result from inflammation arising from a source outside the uterus. The gums are considered a likely source of that inflammation. Inflammation of the gums, or periodontal disease, is common and affects one in seven women of reproductive age in Australia. We have a good understanding of the potential mechanisms by which inflamed gums may cause problems in pregnancy by releasing chemicals into the blood stream. Many of these chemicals have powerful abilities to cause premature labour. Several studies have now shown that pregnant women with gum disease are more likely to deliver early. There has been one controlled study, published recently from Chile, which found that relatively simple treatment of gum disease reduced the rate of premature birth to one fifth that in the untreated group. This application is for funds to conduct a controlled study of treatment of gum disease in an Australian population aimed at reducing the rate of premature birth and other important complications of pregnancy. 5400 pregnant women will have a simple screening test of their gums and 1094 with gum disease will be invited to have treatment. Of these, half will be offered an oral health treatment program during mid- and late-pregnancy, while the other half will be offered similar treatment but after completion of the pregnancy. The treatments are straightforward, provided by hygienists under specialist supervision, and are suitable to be applied to the entire population of pregnant women if found to significantly reduce the rate of premature births.Read moreRead less