Jim Kling

August 29, 2014

MUNICH, Germany — First results from AMBITION, the large pulmonary arterial hypertension trial, will be presented at the European Respiratory Society (ERS) International Congress 2014, which runs from September 6 to 10.

Congress chair Oliver Eickelberg, MD, from the University Hospital of the Ludwig-Maximilians University in Munich, walked Medscape Medical News through the meeting highlights.

The phase 4 AMBITION trial is comparing the combination of an endothelin-receptor agonist (Ambrisentan, Gilead and GlaxoSmithKline) and a phosphodiesterase-5 inhibitor (Tadalafil, Lilly ICOS) with each drug alone in the treatment of pulmonary arterial hypertension.

The primary outcome is time to clinical failure. Each drug alone has been shown to improve 6-minute walking distance, and it is hoped the drugs will have a synergistic effect in combination.

The field of pulmonary arterial hypertension is burgeoning with new therapeutic approaches, and Robert Sandhaus, MD, clinical director of the Alpha-1 Foundation and professor at the National Jewish Health in Denver, said he isn't sure what to make of it all. "I'm waiting for the hubbub to settle down to find out what the actual best approach is," he told Medscape Medical News.

A joint session with the New England Journal of Medicine will look at treatment options in idiopathic pulmonary fibrosis. It will feature updates and results from studies of pirfenidone and nintedanib, which are both in late-stage clinical development for this fatal disease.

New Guidelines

The ERS and the American Thoracic Society will release guidelines for the treatment and diagnosis of severe asthma. "There's a big problem in terms of socioeconomic factors; patients are consuming a substantial portion of the budget for asthma in different parts of the world," said Carlos Baena-Cagnani, MD, president of the Interasma Global Asthma Association and director of the Centre for Research in Respiratory Medicine at Catholic University of Cordoba, Argentina.

Dr. Baena-Cagnani told Medscape Medical News he is looking forward to learning about emerging risk factors for asthma and chronic obstructive pulmonary disease (COPD). Environmental factors such as air pollution and smoking are well known, but other risk factors, such as obesity and poverty, are less well understood, he pointed out.

"Most of the studies of risk factors have been conducted in Europe and the United States, which is home to just 1 billion of the world's 7 billion or so occupants," said Dr. Baena-Cagnani. "We don't know what the risk factors are in less developed countries. Living in extreme environmental conditions is not playing a major role in these affluent groups in the suburbs of American cities or in Europe."

It's an interesting and a confusing time for physicians.

There are many novel treatments for COPD, and that is creating some uncertainty for physicians, said Dr. Sandhaus. "Everybody seems to be wondering, 'What's the first line of therapy going to be for newly diagnosed patients? What's the next treatment for patients already on some inhaler and needing something else? It's an interesting and a confusing time for physicians."

A poster session on new clinical evidence for asthma and COPD treatments promises to provide some insight.

Dr. Sandhaus said he is interested in learning whether any of the combinations can match the benefit of steroid inhalers, which he said he prefers to avoid because of systemic adverse effects. "I'm curious whether some of these beta agonist and muscarinic antagonist combinations can hold their own against steroids," he noted.

The meeting will feature numerous presentations on asthma and COPD treatments that are in late-stage clinical development. Other sessions will look at the treatment of COPD exacerbations. "That's a big area of interest," said Dr. Sandhaus.

At one session, the ERS and the World Health Organization will launch a framework for eliminating tuberculosis, and will discuss an intervention using mobile phones.

Despite all efforts, respiratory health poses a tremendous public health challenge, according to Dr. Eickelberg. Worldwide, COPD is the third leading cause of death. Lung cancer remains problematic. Tuberculosis continues its resurgence, with drug-resistant forms on the rise and popping up in new places as a result of increased mobility. That means there is plenty of work to be done in respiratory medicine, he pointed out. "There's no noninfectious lung disease we can cure yet."

Dr. Eickelberg and Dr. Baena-Cagnani have disclosed no relevant financial relationships. Dr. Sandhaus has consulted for Grifols, Baxter, CSL Behring, and Kamada.


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