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.

Protocol 012 Investigators (2020). Gefapixant, a P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough: a randomised, double-blind, controlled, parallel-group, phase 2b trial. The Lancet Respiratory Medicine.

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BACKGROUNDPeanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions. METHODS Randomization and BlindingEligible participants were randomly assigned, in a 3:1 ratio, to receive either AR101, a peanut-derived pharmaceutical product that was manufactured

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.

; for the Pediatric Montelukast Study Group Context.-Leukotrienes are important mediators of asthma by causing bronchoconstriction, mucous secretion, and increased vascular permeability. Studies using compounds that block leukotrienes have demonstrated improvement in asthma control in adults and adolescents, but children younger than 12 years, for whom asthma is the most common chronic disease, have not been studied. Objective.-To determine the clinical effect of montelukast, a leukotriene receptor antagonist, in 6-to 14-year-old children with asthma. Design.-Eight-week, multicenter, randomized, double-blind study. Setting.-Forty-seven outpatient centers at private practices and academic medical centers in the United States and Canada. Patients.-A total of 336 children with forced expiratory volume in 1 second (FEV 1) between 50% to 85% of the predicted value, at least 15% reversibility after inhaled ␤-agonist administration, a minimal predefined level of daytime asthma symptoms, and daily ␤-agonist use. Concomitant inhaled corticosteroids at a constant daily dose were used by 39% of patients receiving montelukast and 33% receiving placebo. Intervention.-After a 2-week placebo run-in period, patients received either montelukast (5-mg chewable tablet) or matching-image placebo once daily at bedtime for 8 weeks. Main Outcome Measure.-Morning FEV 1 percent change from baseline. Results.-Mean morning FEV 1 increased from 1.85 L to 2.01 L in the montelukast group and from 1.85 L to 1.93 L in the placebo group. This represents an 8.23% (95% confidence interval [CI], 6.33% to 10.13%) increase from baseline in the montelukast group and a 3.58% (95% CI, 1.29% to 5.87%) increase from baseline in the placebo group (PϽ.001 for montelukast vs placebo). Conclusion.-Montelukast improves morning FEV 1 in 6-to 14-year-old children with chronic asthma.

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Both montelukast and inhaled corticosteroids were effective in controlling mild to moderate chronic asthma; the relative effectiveness of montelukast and beclomethasone were similar in open-label conditions. The hypothesis, that clinical practice conditions (e.g., adherence) may have a significant impact on the effectiveness of these therapies, should be tested in future clinical trials.