Australian sufferers of chronic obstructive pulmonary disorder (COPD), one of the most important causes of breathlessness and difficulty performing tasks of normal daily life, have the opportunity to participate in a worldwide study, starting this month, assessing a potential new treatment.

With more than two million Australians suffering from COPD, the financial costs associated with the disorder are huge – almost $7 billion lost in productivity alone [1]– separate from the personal impact.

The study, being conducted by GlaxoSmithKline (GSK), is seeking at least 80 participants in Australia who have been diagnosed with COPD and who are or have been smokers. Other terms commonly used to describe COPD include emphysema and chronic bronchitis.

According to Associate Professor Matthew Peters of the Concord Repatriation General Hospital,

“There is a spectrum of important symptoms that may be associated with COPD including breathlessness, frequent cough and fatigue. The effect of these is to make life more difficult and people living with COPD report impairment of their quality of life.

“We know that there are existing treatments that can reduce these symptoms and improve life and lifestyle. The challenge now is to seek further improvement and to simplify treatments – ideally reducing this to one dose each day and mixing effective treatments in one inhaler.”

This study, being conducted simultaneously in 40 locations around the world, will investigate the effectiveness of a potential new treatment for COPD that does combine two new medicines in a single inhaler. This new treatment is being compared to what we would regard now as best practice treatment for patients with COPD.

The trial medicine will be provided free and participants may benefit from regular medical check-ups conducted by some of the country’s leading respiratory experts and from the enhanced knowledge and understanding of their own condition that being in a trial offers.

“This study is measuring what is important to patients – symptoms, lung function and quality of life. If on these measures the novel treatment is better than what we presently have, it would be a great advance for Australian patients living with COPD now. We’re delighted to be one of the countries taking part,” Associate Professor Peters said.

To be eligible to participate, patients need to be 40 years and over, diagnosed with COPD, a current or ex-smoker, experiencing some breathlessness. If you have been recently hospitalised you could be recruited but after your condition has stabilised.

Q & A

1. Why is this study being undertaken?

As at October 2008 over 2 million Australians were estimated to have chronic obstructive pulmonary disorder (COPD), a condition that has major effects on quality of life for sufferers and their families and which bears a tremendous cost for both individuals and society.

This study, being conducted simultaneously in 40 locations around the world, will investigate the effectiveness of a potential new treatment for COPD that delivers two bronchodilator (airway-opening) medicines in a single inhaler. Combining two such medicines in the one inhaler may offer simplicity and convenience for patients.

2. What is unique about this study?

International and Australian COPD treatment guidelines currently suggest the use of multiple bronchodilators (airway-opening medicines) daily as required to help breathless patients. These bronchodilators are currently available in separate inhalers. This study will investigate the effectiveness of combining two bronchodilators in a single inhaler used once daily.

3. What will the results deliver?

Currently large numbers of COPD sufferers need multiple medications on a daily basis. Should the results of this study demonstrate the effectiveness of these new medications, COPD patients may be able to have a greater choice in how to manage their condition.

Combining two medicines in the one inhaler may offer simplicity and convenience for patients. A potential reduction in the number of treatments could improve regular use of the medicine, and alleviate the costs associated with minimising symptoms.

These factors combined could also provide patients with a greater quality of life related to their health.

4. What is the review process, which ensures the study, is safe?

Clinical research cannot be undertaken in Australia without approval from authorised medical regulatory authorities who ensure research practices are ethical and conducted via safe and professional means. This study has been reviewed and approved by the following regulatory bodies, in:

Queensland:

• The University of QLD Human Research Ethics Committee
• Bellberry Limited Human Research Ethics Committee
• The Royal Brisbane & Women’s Hospital Human Research Ethics Committee

New South Wales:

• Sydney Local Health Network Human Research Ethics Committee

Victoria:

1. St Vincent’s Hospital (Melbourne) Human Research Ethics Committee

South Australia:

• The Southern Adelaide Clinical Human Research Ethics Committee

Western Australia:

• Bellberry Limited Human Research Ethics Committee

The Therapeutic Goods Administration (TGA) in Canberra has also been notified of the study. Only fully trained medical professionals will administer this research.

4. Who should participate?

To be eligible to participate patients need to be 40 years and over, diagnosed with COPD, a current or ex-smoker, experiencing shortness of breath and be free of a COPD hospitalisation history in the three months prior to the study. Other qualifying criteria apply but these are discussed in detail individually, with the doctors and nurses conducting the study.

5. Why should they participate?

Those who are eligible to participate should seriously consider taking part. Participants will receive free active study treatment during the course of the program, regular medical check ups and access to some of Australia’s highly qualified respiratory doctors without long waiting periods for appointments.

Not only will they receive regular reviews and assessment of their own medical condition but they will also be helping respiratory research that is aimed at improving the health of COPD suffers worldwide, including more than 2 million fellow Australians.

6. Where will the study take place?

There are 10 study sites confirmed around Australia:

• AusTrials - Caboolture Clinical Research Centre, Caboolture QLD
• Brisbane South Clinical Research Centre, Carina Heights QLD
• Cairns Base Hospital, Cairns QLD
• Repatriation General Hospital, Daw Park SA
• Royal Adelaide Hospital, Adelaide SA
• Frankston Hospital, Frankston VIC
• Royal Melbourne Hospital, Melbourne VIC
• Concord Repatriation General Hospital, Concord NSW
• Sir Charles Gairdner Hospital, Nedlands WA
• Lung Institute of WA, Nedlands WA

7. When does the study start and how long will it go for?

Enrolment in the study opened in May 2011 and will close in November 2011. Participation will be for up to six months from the date on which each patient is enrolled in the study.

8. What does the study involve for participants?

Upon confirmation of participation patients will be asked to stop taking their current airway widening medication and will be provided with study medication, free of charge, for up to six months. Throughout the course of the study patients will be required to see the consulting doctor four times in the
first two weeks and then monthly for six months. Most visits will entail simple breathing checks and tests and on some occasions a blood test.

In majority of cases, visits will be approximately one hour in length however on three separate occasions patients will be required to attend a more extensive examination, which will take between seven and eight hours. On this visit patients will receive meals and will be financially compensated for their time. Patients will also be reimbursed for their travel expenses to attend study visits. Patients are required to complete a paper diary entry each day and an electronic diary twice daily.

9. How does one get involved?

Those interested in participating should seek more information by calling, toll free, 1800 800 285. Patients who meet the study criteria will be referred to a study centre and will be contacted by a doctor or study nurse who will invite them to a clinic for further consultation.

At this consultation patients will receive further in-depth information about the study and their participation and will have the opportunity to sign up to participate.

About chronic obstructive pulmonary disorder (COPD)

Chronic obstructive pulmonary disorder (COPD) is a preventable and treatable progressive lung disease characterised by a persistent blockage of airflow from the lungs, commonly known as chronic bronchitis, emphysema or smokers’ cough.

The most common symptoms of COPD are breathlessness, excessive sputum production and a persistent cough.

Risk factors for COPD include smoking, environmental exposure to dusts/chemical fumes, age, socioeconomic status and a history of respiratory infection.

COPD can often complicate other chronic conditions such as diabetes, chronic heart failure and cerebrovascular disease, resulting in worse prognosis.

COPD is more common in any given year than the most common types of cancer, road traffic accidents, ear disease or diabetes1.

In Australia:

As at October 2008 it was estimated that over 2 million Australians were suffering COPD - 1.2 million of those persons have it severe enough that it affects their everyday lives. At that same time COPD was also identified as the cause of one death every 30 minutes in Australia. According to the World Health Organisation, COPD is set to be the third biggest killer across the globe by 2030.

Although preventable, COPD is under-recognised and under-treated in Australia. If nothing is done to change this trend, an estimated 4.5 million Australians will suffer COPD by 2050.

Cost:

COPD carries a tremendous cost to the government, the taxpayers and importantly sufferers, their families and their carers.

In 2008 the financial cost of COPD was $8.8 billion

• $6.8 billion was productivity lost due to lower employment absenteeism, and premature death of Australians with COPD
• $0.9 billion was direct health system expenditure
• $0.9 billion was deadweight losses from transfers including welfare payments and taxation forgone
• $0.3 billion was other indirect costs such as aids and home modifications and the bring-forward of funeral costs.
• Per capita, the financial cost to a person suffering COPD is $7,446 per annum.

Treatment:

While incurable, evidence shows that proper management of COPD can improve quality of life, increased exercise capacity and a reduction in morbidity in affected individuals.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

[1] “Economic Impact of COPD and cost effective solutions” Report by Access Economics Pty Limited on behalf of The Australian Lung Foundation, 16/08/2008