Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children.

摘要: Background Asthma is characterised by chronic inflammation of the airways and recurrent exacerbations with wheezing, chest tightness cough. Treatment inhaled steroids bronchodilators often results in good control symptoms, prevention further morbidity mortality improved quality life. Several beta2-agonists (long- short-acting) as well combinations these treatments are available a single inhaler to be used once or twice day, separate for relief symptoms when needed (for patients Step three higher, according Global Initiative Asthma (GINA) guidelines). Budesonide/formoterol also licenced use maintenance reliever therapy from (SiT; sometimes referred SMART therapy). SiT can prescribed at lower dose than other combination because additional steroid doses being received therapy. It has been suggested that using improves compliance hence reduces exacerbations, but it unclear whether increases side effects associated steroids. Objectives To assess efficacy safety budesonide/formoterol (SiT) both asthma comparison treatment provided through inhalers higher (either fluticasone/salmeterol budesonide/formoterol), along fast-acting symptoms. Search methods We searched Cochrane Airways Group Specialised Register trials, online trial registries drug company websites. The most recent search was conducted November 2013. Selection criteria We included parallel-group, randomised controlled trials least 12 weeks' duration. Studies were if they compared single-inhaler versus given arm salmeterol/fluticasone budesonide/formoterol). Data collection analysis We standard methods expected Collaboration. Primary outcomes requiring hospitalisation, oral corticosteroids serious adverse events (including mortality). Main results Four studies randomly assigning 9130 people included; two six-month double-blind studies, 12-month open-label studies. No children younger age 12. Trials more women men, mean ranging 38 45, baseline (inhaled beclomethasone (BDP) equivalent) 636 888 μg. Mean forced expiratory volume one second (FEV1) percentage predicted between 70% 73% 96% another. All funded AstraZeneca generally free methodological biases, although rated having high risk blinding, some evidence selective outcome reporting found. These possible sources bias did not lead us downgrade evidence. quantity steroids, including puffs taken consistently groups. Separate data leading hospitalisations, emergency room (ER) visits course could obtained. Compared fixed-dose inhalers, fewer had hospitalisation visit ER (odds ratio (OR) 0.72, 95% confidence interval (CI) 0.57 0.90; I2 = 0%, P 0.66), (OR 0.75, CI 0.65 0.87; 0.82). This translates less person admitted hospital visiting (95% 0 2 fewer) needing 1 3 short-acting beta-agonist (SABA) (per 100 treated over eight months). statistical heterogeneity observed either outcome, quality. Although issues blinding evident study recruited severe population, sensitivity analyses change main results, so downgraded. We rule out possibility increased rates 0.92, 0.74 1.13; 0.98; moderate-quality evidence, downgraded owing imprecision). We unable say several secondary (morning evening peak flow (PEF), rescue medication use, scales), cases where significant, effect sizes considered clinically meaningful (predose FEV1, nocturnal awakenings life). Authors' conclusions SiT number an inhalers. Evidence unclear. daily (ICS) SiT, total administered always groups. suggests flexibility administration might effective increasing only keeping low during stable stages disease. Data hospitalisations alone obtained, no have yet addressed this question