A 1-year randomized, stratified double-blind parallel-group study of 3,416 patients with uncontrolled asthma showed that the stringent standard of total control was achieved by 41 percent of all patients from 3 separate study groups during at least 7 out of 8 consecutive assessment weeks over the year. The researchers recruited 3 groups of uncontrolled asthma patients: an inhaled steroid naïve group, those on a low-dose inhaled steroid regimen, and a group on moderate dose inhaled steroids. After a 4-week run-in period, the groups were treated with either the inhaled steroid fluticasone propionate alone or in combination with the long-acting beta2-agonist salmeterol. The authors said that significantly more patients in each study group achieved control with the salmeterol/fluticasone combination than with fluticasone alone. Also, control was achieved more rapidly and at a lower corticosteroid dose with salmeterol/fluticasone versus fluticasone alone. According to the authors, total control, by definition, was achieved if the patients, during 8 consecutive assessment weeks, recorded 7 totally controlled weeks with no exacerbations, emergency room "criteria," or medication-related adverse events for each day of each week. They said that such stringent and sustained measures of asthma control had never been previously assessed in clinical trials. They also noted that the results of their study suggest that total control should be the aim of treatment for all asthma patients. The research appears in the second issue for October 2004 of the American Thoracic Society's peer-reviewed American Journal of Respiratory and Critical Care Medicine.
REPLACEMENT TESTOSTERONE ASSISTS CHRONIC OBSTRUCTIVE PULMONARY DISEASE PATIENTS
Replacement doses of the male sex hormone testosterone increased lean body mass and leg muscle strength in men with severe chronic obstructive pulmonary disease (COPD) who suffered from low testosterone levels. According to the authors, this study demonstrates for the first time that strength increases accompany androgenic steroid supplementation in COPD and raises the possibility that testosterone supplementation may be an appropriate therapy in conjunction with a rehabilitative program for patients with muscle weakness. (In COPD, patients have persistent obstruction of the airways associated with either emphysema or chronic bronchitis, which has usually been caused by years of cigarette smoking.) The researchers studied 47 patients in 4 different groups, with 23 receiving testosterone, either with or without exercise. By raising the testosterone levels of these men to the middle of the normal range for young males, the investigators saw lean body mass increase by 2.3 kg with testosterone alone and by 3.3 kg in the combined testosterone and resistance training group. Both groups receiving testosterone supplements experienced significant lean mass increases in the arms, averaging about 6.5 percent; the trunk, averaging approximately 4 percent; and the legs at about 7 percent. The total lean body mass increased averaged 5.5 percent. Also, the men's strength in the 1- repetition maximum leg press increased by 17.2 percent in the testosterone alone group and by 26.8 percent in the testosterone and resistance training group. The study appears in the second issue for October 2004 of the American Thoracic Society's peer-reviewed American Journal of Respiratory and Critical Care Medicine.
METAL-RICH PARTICULATE MATTER CAUSES AIRWAY INFLAMMATION
Instillations of environmentally relevant concentrations of tiny particulate matter (PM2.5) from a smelter area in Germany induced distinct airway inflammation in 12 healthy subjects, as compared with PM2.5 from a nearby rural town. Researchers instilled ambient particles (PM2.5) through a bronchoscope into the lungs of the 12 healthy volunteers. The particulate matter was collected at Hettstedt, a city in an 800-year-old German smelting area, and from Zerbst, a rural community 80 kilometers away. The cities are similar in climate and size. The authors said that the levels of transition metals, including zinc, copper, and cadmium, as well as oxidant generation, were several fold higher in the PM2.5 from Hettsted, as compared with Zerbst. They said that increased metal concentrations and consequent oxidative stress is known to promote factors which can lead to the release of proinflammatory mediators. They pointed out that such results had been demonstrated especially for zinc, which is a major component of environmental particulate matter. This material has induced pulmonary cell reactivity and epithelial damage in animals. The study population consisted of 8 women and 4 men, all healthy volunteers who averaged 27 years of age. Each subject had a normal physical exam, a normal lung function test, and no clinically relevant lab findings. Smokers were excluded from the study. The research appears in the second issue for October 2004 of the American Thoracic Society's peer-reviewed American Journal of Respiratory and Critical Care Medicine.
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Journal
American Journal of Respiratory and Critical Care Medicine