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Important clinical trials in the North

Three major clinical trials in Norway will help to develop and target treatment and follow-up of patients suffering from COPD, lung cancer and rheumatoid arthritis.

 At the Norwegian Centre for Integrated Care and Telemedicine in Tromsø in Northern Norway, researchers will be studying the effects of telemedicine on people suffering from chronic obstructive pulmonary disease (COPD).

“Exercise training and pulmonary rehabilitation are recommended for COPD patients at all stages of the disease. Since we can’t offer all patients pulmonary rehabilitation in an institution, we are working to develop a low-intensity tele-rehabilitation service for patients in their own homes,” explains project manager Paolo Zanaboni.

Roughly 120 patients in Norway, Denmark and Australia will be divided into one intervention group and two control groups. The patients in the intervention group will be given a treadmill and a device that measures their oxygen saturation and pulse rate. They will receive regular follow-up from a physiotherapist via a videoconferencing system on an iPad. The physiotherapist can adjust the exercise training program based on measurements patients enter on a website after each training session. The patients in one of the control groups will receive standard COPD treatment, while the patients in the other control group will be given equipment for exercise training at-home with no telemedical follow-up.

“It’s important to find out whether it is the exercise on its own or the exercise in conjunction with telemedicine that is most effective,” says Paolo Zanaboni.

Lung cancer

Another clinical study, a new cancer study, will explore whether a new therapy principle can extend the lives of patients with metastatic lung cancer. Some 85 percent of the 3000 individuals diagnosed with lung cancer each year have non-small-cell lung cancer. Patients with advanced metastasized cancer have a survival rate of between seven and fourteen months. Normal treatment today consists of four courses of chemotherapy. Patients may be given more chemotherapy when the cancer gets worse.

“Instead of watching and waiting after the four standard courses of chemotherapy, we will be studying the effect of immediate pemetrexed maintenance therapy. Prior studies have shown that this can prolong survival by three to five months, or 40–50 percent,” says project manager Bjørn Grønberg, a consultant in oncology at the Cancer Clinic at St. Olavs Hospital in Trondheim. “No other studies on this patient group have even hinted at a similar improvement in survival rate.”

Approximately 25 Norwegian hospitals will be participating in the clinical trial, which will involve 700 patients over a two-and-a-half-year period.

Rheumatoid arthritis

In the past 10–15 years, new biologic drugs for rheumatoid arthritis have emerged that have shown excellent results when used with modern treatment strategies.

“Nine of ten patients with recently diagnosed rheumatoid arthritis who are treated according to these principles will cease to exhibit signs or symptoms of active disease,” explains project manager Espen A. Haavardsholm at Diakonhjemmet Hospital in Oslo.

The downside is that biologics are costly, and suppress the immune system to an extent that increases the risk of infection.

Now Espen A. Haavardsholm and his colleagues are looking to see if it is possible to discontinue the drugs and still keep patients symptom-free.

One group of patients will gradually taper off and withdraw from biologics, continuing standard treatment with older types of drugs. Another group will continue taking biologics.

“Perhaps the study will reveal that some patients should continue taking biologics, while others should stop. We will be looking for predictors that can indicate this at an early stage,” says Espen A. Haavardsholm.

The clinical trial will involve 320 rheumatoid arthritis patients throughout Norway.