乌鸦传媒

SAN DIEGO -- A trial of hydrogel-based lung volume reduction therapy in patients with chronic obstructive pulmonary disease (COPD) complicated by emphysema failed to show consistent enough results and has been abandoned by the agent's developer, researchers said here.

More than 50% of the patients receiving the emphysematous lung sealant (AeriSeal) along with medical treatment experienced Minimal Clinically Improvement Change Scores in forced expiratory volume in 1 s (FEV1), in the St. George Respiratory Questionnaire, and in the Modified Medical Research Council Dyspnea scale, reported of Brigham & Women's Hospital in Boston, and colleagues at the American Thoracic Society (ATS) annual meeting.

However, Washko said the improvements in lung function came at a cost -- 43% of the patients treated with the lung sealant required hospitalization compared with 19% of the patients in the medical treatment-only control group (P<0.05).

Also, about 39% of the patients in the treatment group were hospitalized for adverse respiratory events versus 15% in the control group. Finally, there was one treatment-related death among the patients in the study arm (versus no deaths in the control group).

The planned year-long evaluation of the lung foam was cut short at 6 months by

The ASPIRE trial was a multicenter, randomized, controlled study started in September 2012. Eligible patients were at least 40-years-old and had smoked at least 20-pack years of cigarettes. They had to have a diagnosis of upper lobe emphysema and have an FEV1 of less than 50%. Patients with previous surgery for lung volume reduction, those who had active lung infections, and those who had left ventricular ejection fraction of less than 45% were excluded.

Patients who made it into the study were about 65-years-old and more than half were women. Both controls and treated patients had accumulated 50-pack years of smoking. The trial's primary endpoint was improvement in FEV1 at 12 months relative to baseline.

At the time of termination, safety data were available for 90 patients. The authors reported that at 3 and 6 months, patients treated with the lung sealant saw improvements in FEV1 by 11% and 19%, respectively.

Scores on the St. George Respiratory Questionnaire decreased by 11 points at 3 months and by 12 points at 6 months.

Scores on the Modified Medical Research Council Dyspnea Scale decreased by 1 point at 3 months and that reduction was maintained at 6 months.

Changes among the controls were minimal, the group reported.

ATS session moderator from the University of Kiel in Germany, described the study as "well-composed ... the researchers were very open, and it was not presented in a company-bias form. [Washko] was trying to find out if patients' outcomes would be better." He added that "there is clear harm for some patients. There is benefit for others."

But Rabe pointed out that there are a number of different competing options for different morphologies of the lung (mainly emphysema), such as coils, steam, foam, and valves.

"Of all the options for lung volume reduction, the foam one is the least likely to make it to the market because it is irreversible," he said. "The long-term effects are not known. I think it is valves and coils that are at the forefront."

He said that he would prefer to work with an "inert material that I could remove again. I think that the problem with foam is that you squirt it somewhere and there it is. There is no way to get rid of it. It is easy to place things; it is difficult to take [them] out."

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