The clinical benefit and steroid-sparing effect of treatment with the antiimmunoglobulin-E (IgE) antibody, omalizumab, was assessed in patients with moderateto-severe allergic asthma.After a run-in period, 546 allergic asthmatics (aged 12-76 yrs), symptomatic despite inhaled corticosteroids (500-1,200 mg daily of beclomethasone dipropionate), were randomized to receive double-blind either placebo or omalizumab every 2 or 4 weeks (depending on body weight and serum total IgE) subcutaneously for 7 months. A constant beclomethasone dose was maintained during a 16-week stable-steroid phase and progressively reduced to the lowest dose required for asthma control over the following 8 weeks. The latter dose was maintained for the next 4 weeks. Asthma exacerbations represented the primary variable.Compared to the placebo group, the omalizumab group showed 58% fewer exacerbations per patient during the stable-steroid phase (pv0.001). During the steroid-reduction phase, there were 52% fewer exacerbations in the omalizumab group versus the placebo group (pv0.001) despite the greater reduction of the beclomethasone dosage on omalizumab (pv0.001). Treatment with omalizumab was well tolerated. The incidence of adverse events was similar in both groups.These results indicate that omalizumab therapy safely improves asthma control in allergic asthmatics who remain symptomatic despite regular use of inhaled corticosteroids and simultaneous reduction in corticosteroid requirement.

The influence of pulmonary resection on functional capacity can be assessed in different ways. The aim of this study was to compare the effect of lobectomy and pneumonectomy on pulmonary function tests (PFT), exercise capacity and perception of symptoms.Sixty eight patients underwent functional assessment with PFT and exercise testing before (Preop), and 3 and 6 months after lung resection. In 50 (36 males and 14 females; mean age 61 yrs) a lobectomy was performed and in 18 (13 males and 5 females; mean age 59 yrs) a pneumonectomy was performed.Three months after lobectomy, forced vital capacity (FVC), forced expiratory volume in one second (FEV1), total lung capacity (TLC), transfer factor of the lungs for carbon monoxide (TL,CO) and maximal oxygen uptake (V'O 2 ,max) were significantly lower than Preop values, increasing significantly from 3 to 6 months after resection. Three months after pneumonectomy, all parameters were significantly lower than Preop values and significantly lower than postlobectomy values and did not recover from 3 to 6 months after resection. At 6 months after resection significant deficits persisted in comparison with Preop: for FVC 7% and 36%, FEV1 9% and 34%, TLC 10% and 33% for lobectomy and pneumonectomy, respectively; and V'O 2 ,max 20% after pneumonectomy only. Exercise was limited by leg muscle fatigue in 53% of all patients at Preop. This was not altered by lobectomy, but there was a switch to dyspnoea as the limiting factor after pneumonectomy (61% of patients at 3 months and 50% at 6 months after resection). Furthermore, pneumonectomy compared to lobectomy led to a significantly smaller breathing reserve (mean±SD) (28±13 vs 37±16% at 3 months; and 24±11% vs 33±12% at 6 months post resection) and lower arterial oxygen tension at peak exercise 10.1±1.5 vs 11.5±1.6 kPa (76±11 vs 86±12 mmHg) at 3 months; 10.1±1.3 vs 11.3±1.6 kPa (76±10 vs 85±12 mmHg) at 6 months postresection.We conclude that measurements of conventional pulmonary function tests alone overestimate the decrease in functional capacity after lung resection. Exercise capacity after lobectomy is unchanged, whereas pneumonectomy leads to a 20% decrease, probably due to the reduced area of gas exchange.

Exercise testing with measurement of maximal oxygen uptake (VO2max) is increasingly used in the assessment of lung resection candidates, but its predictive value for postoperative complications remains controversial. We therefore sought to determine the prognostic value of VO2max compared with other pulmonary function tests. A consecutive group of 80 patients (mean age 61 yr; 57 males and 23 females) scheduled for lung resection (62 malignancies, 12 benign disorders, and 6 carcinoids) underwent pulmonary function tests and symptom-limited cycle ergometry. All patients underwent lung resections: 21 pneumonectomies, 45 lobectomies, and 14 segmental or wedge resections. Group A (64 patients, 80%) had an uneventful postoperative course, whereas Group B (16 patients, 20%) had complications; 3 of them died (4% overall mortality rate). In a stepwise logistic regression analysis used to determine independent risk factors for postoperative complications (within 30 d), VO2max expressed as a percentage of predicted (84 +/- 19 for Group A versus 61 +/- 11 for Group B) proved to be the best predictor (predictive value 85.5%). Although VO2max expressed in absolute values (ml/kg/min) was also highly predictive (79.5%), a ROC curve analysis proved the percentage predicted values to be significantly more sensitive. Of 9 patients with a VO2max < 60% of predicted, 8 had complications, including all 3 patients who died after resections of more than one lobe (sensitivity 50%, specificity 98%). The estimated probability (probit model SAS software package) of suffering no complication was 0.9 for VO2max > 75% of predicted and 0.1 for a VO2max < 43%.(ABSTRACT TRUNCATED AT 250 WORDS)

The ability of omalizumab, an anti-immnoglobulin-E agent, to maintain long-term disease control in patients with moderate-to-severe allergic asthma was investigated in a 24-week double-blind extension to a 28-week core trial.During the extension, 483 of the initial 546 patients were maintained on randomised treatment and the lowest sustainable dose of beclomethasone dipropionate (BDP) as established during the steroid-reduction phase of the core trial. The use of concomitant asthma medication was permitted and investigators were allowed to adjust the BDP dose or switch patients from BDP to other asthma medications if deemed necessary.More omalizumab-treated patients (33.5%) than placebo-treated patients (13.5%) were able to complete the extension period without requiring inhaled corticosteroid treatment. The mean BDP equivalent dose throughout the extension was lower in the omalizumab group (25 mg?day -1 ) than in the placebo group (43 mg?day -1 ). Disease control was sustained in 76% of omalizumab patients compared with 59.4% of placebo patients free from an asthma exacerbation during the extension period. Compared with placebo, fewer patients in the omalizumab group used other concomitant asthma medication during the extension. Treatment with omalizumab was well tolerated and the incidence of adverse events was similar between groups.In conclusion, these results suggest that omalizumab is a promising new agent for the long-term control of allergic asthma. Eur Respir J 2002; 20: 73-78.

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