s-1743 and Asthma

Gastro-oesophageal reflux disease (GORD) is suggested to cause or aggravate several respiratory conditions. Studies with proton pump inhibitors have resulted in only minor improvements in pulmonary outcomes in patients with GORD. It has been speculated that operative treatment of GORD might be more efficient as it also diminishes non-acidic reflux.. To compare the effects of esomeprazole 40 mg bid and fundoplication on airway responsiveness, forced expiratory volume in 1 s (FEV1), exhaled nitric oxide (NO) and respiratory symptoms in patients with moderate-to-severe GORD.. Sixty-nine GORD patients had methacholine inhalation challenge performed on them, and FEV1, exhaled NO and respiratory symptoms were measured at baseline, after a 3-month treatment with esomeprazole and 3 months after fundoplication. Primary outcome variable was dose-response slope (DRS), i.e. decline in FEV1 during methacholine challenge divided with the amount of methacholine administered (%/μmol). Pre-defined subgroup analysis was performed among those with concomitant asthma (n = 12).. There was no improvement in DRS, FEV1 or exhaled NO after esomeprazole treatment or fundoplication. Cough and dyspnoea measured with visual analog scale improved with esomeprazole treatment (P < 0.001), and further after fundoplication (P < 0.001). Among those with concomitant asthma, significant improvements in St George Respiratory Questionnaire (SGRQ) scores could be seen after fundoplication.. Neither esomeprazole treatment nor fundoplication diminishes airway responsiveness or exhaled NO, or improves FEV1 in patients with GORD. Improvements in respiratory symptoms and SGRQ scores after GORD treatments could be detected. However, as this was not a placebo-controlled study, the findings in these secondary endpoints should not be emphasised. ClinicalTrials.cov: NCT00994708.

Topics: Adult; Aged; Anti-Ulcer Agents; Asthma; Breath Tests; Bronchial Hyperreactivity; Esomeprazole; Female; Forced Expiratory Volume; Fundoplication; Gastroesophageal Reflux; Humans; Male; Middle Aged; Nitric Oxide; Treatment Outcome

Gastroesophageal reflux disease (GERD) is common among patients with asthma; however, studies investigating the effect of proton pump inhibitors on asthma outcomes report conflicting results.. To investigate the effect of esomeprazole 40 mg once or twice daily on asthma outcomes in patients with concomitant symptoms of GERD.. This 26-week, randomized, double-blind, placebo-controlled study (NCT00317044) included adult patients (18-70 yr) with moderate-to-severe asthma and symptomatic GERD. The change in morning peak expiratory flow (primary variable), evening peak expiratory flow, FEV(1), asthma symptoms, Asthma Quality of Life Questionnaire, Reflux Disease Questionnaire, and tolerability were assessed.. A total of 961 patients were randomized and 828 completed the study. Relative to baseline, improvement in morning peak expiratory flow was observed for both esomeprazole 40 mg once daily (+3.5 L/min; 95% CI, -3.2 to 10.2) and 40 mg twice daily (+5.5 L/min; 95% CI, -1.2 to 12.2), although no statistically significant between-treatment differences were apparent. At treatment end, both doses of esomeprazole significantly improved FEV(1) versus placebo (+0.09 L and +0.12 L; P = 0.0039 and P < 0.0001, respectively). However, only esomeprazole 40 mg twice daily demonstrated a significant improvement when FEV(1) was calculated over the entire 26-week period (+0.07 L; P = 0.0042). Significant improvements in Asthma Quality of Life Questionnaire total score were demonstrated for both esomeprazole doses compared with placebo (+0.28 and +0.41; P = 0.0006 and P < 0.0001, respectively).. Esomeprazole may improve pulmonary function and asthma-related quality of life. However, the improvements were minor and of small clinical significance.

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Asthma; Double-Blind Method; Esomeprazole; Female; Forced Expiratory Volume; Gastroesophageal Reflux; Humans; Male; Middle Aged; Placebos; Proton Pump Inhibitors; Sickness Impact Profile; Spirometry; Young Adult

Gastroesophageal reflux is common among patients with asthma but often causes mild or no symptoms. It is not known whether treatment of gastroesophageal reflux with proton-pump inhibitors in patients who have poorly controlled asthma without symptoms of gastroesophageal reflux can substantially improve asthma control.. In a parallel-group, double-blind trial, we randomly assigned 412 participants with inadequately controlled asthma, despite treatment with inhaled corticosteroids, and with minimal or no symptoms of gastroesophageal reflux to receive either 40 mg of esomeprazole twice a day or matching placebo. Participants were followed for 24 weeks with the use of daily asthma diaries, spirometry performed once every 4 weeks, and questionnaires that asked about asthma symptoms. We used ambulatory pH monitoring to ascertain the presence or absence of gastroesophageal reflux in the participants. The primary outcome was the rate of episodes of poor asthma control, as assessed on the basis of entries in asthma diaries.. Episodes of poor asthma control occurred with similar frequency in the placebo and esomeprazole groups (2.3 and 2.5 events per person-year, respectively; P=0.66). There was no treatment effect with respect to individual components of the episodes of poor asthma control or with respect to secondary outcomes, including pulmonary function, airway reactivity, asthma control, symptom scores, nocturnal awakening, or quality of life. The presence of gastroesophageal reflux, which was documented by pH monitoring in 40% of participants with minimal or no symptoms, did not identify a subgroup of patients that benefited from treatment with proton-pump inhibitors. There were fewer serious adverse events among patients receiving esomeprazole than among those receiving placebo (11 vs. 17).. Despite a high prevalence of asymptomatic gastroesophageal reflux among patients with poorly controlled asthma, treatment with proton-pump inhibitors does not improve asthma control. Asymptomatic gastroesophageal reflux is not a likely cause of poorly controlled asthma. (ClinicalTrials.gov number, NCT00069823.)

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Asthma; Bronchodilator Agents; Double-Blind Method; Drug Therapy, Combination; Esomeprazole; Female; Forced Expiratory Volume; Gastroesophageal Reflux; Humans; Male; Proton Pump Inhibitors; Regression Analysis; Treatment Failure

Silent gastroesophageal reflux (GER) is common in patients with asthma, but it is unclear whether GER is associated with worse asthma symptoms or reduced lung function.. To determine in patients with poorly controlled asthma, whether proximal or distal esophageal reflux is associated with asthma severity, symptoms, physiology, or functional status.. Baseline asthma characteristics were measured in patients with asthma enrolled in a multicenter trial assessing the effectiveness of esomeprazole on asthma control. All participants underwent 24-hour esophageal pH probe monitoring. Lung function, methacholine responsiveness, asthma symptoms, and quality-of-life scores were compared in subjects with and without GER.. Of 304 participants with probe recordings, 53% had reflux. Of 242 participants with recordings of proximal pH, 38% had proximal reflux. There was no difference in need for short-acting bronchodilators, nocturnal awakenings, dose of inhaled corticosteroid, use of long-acting beta-agonists, lung function, or methacholine reactivity between individuals with and without proximal or distal GER. Participants with GER reported more use of oral corticosteroids and had worse asthma quality of life and subjects with proximal GER had significantly worse asthma quality of life and health-related quality of life compared with participants without GER.. Asymptomatic GER is not associated with distinguishing asthma symptoms or lower lung function in individuals with suboptimal asthma control who are using inhaled corticosteroids. Patients with proximal reflux report significantly worse asthma and health-related quality of life despite lack of physiologic impairment or increase in asthma symptoms. Clinical trial registered with www.clinicaltrials.gov (NCT00069823).

Topics: Adrenal Cortex Hormones; Adult; Anti-Ulcer Agents; Asthma; Esomeprazole; Female; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Lung; Male; Monitoring, Physiologic; Quality of Life; Severity of Illness Index

To evaluate the asthma outcome of treatment with ranitidine or esomeprazole plus metoclopramide in older children with moderate-persistent asthma and gastroesophageal reflux disease (GERD).. The study patients included 44 patients with asthma and GERD who had received 1 year of treatment with a proton pump inhibitor/prokinetic combination and had shown significant clinical improvement in asthma symptoms and no exacerbations for more than 3 months. For further treatment, 30 of the 44 patients continued treatment with esomeprazole/metoclopramide (group A), and 14 switched to ranitidine (group B). Nine patients with GERD and asthma who had previously undergone fundoplication were used as control individuals (group C). All patients were followed up closely for exacerbation of asthma symptoms and treated according to a standardized protocol.. During the 6-month follow-up, group B patients experienced significantly more exacerbations per patient (2.2) than did those in group A (0.33) or group C (0.77) (P < 0.05).. Fundoplication or continued treatment with esomeprazole and metoclopramide is associated with significantly fewer exacerbations of asthma symptoms in children with moderate-persistent asthma and concomitant GERD in comparison with treatment with ranitidine.

Topics: Adolescent; Anti-Ulcer Agents; Antiemetics; Asthma; Child; Comorbidity; Enzyme Inhibitors; Esomeprazole; Female; Fundoplication; Gastroesophageal Reflux; Humans; Male; Metoclopramide; Proton Pump Inhibitors; Ranitidine; Treatment Outcome

Gastroesophageal reflux disease (GERD) is common in patients with asthma, suggesting an interaction between the two conditions.. To assess the effect of gastric acid suppression with the proton pump inhibitor esomeprazole on asthma outcomes in subjects with persistent moderate to severe asthma treated with antiinflammatory asthma medication.. In this double-blind study, subjects were randomized to receive esomeprazole 40 mg or placebo twice daily for 16 wk. According to nocturnal respiratory symptoms (NOC) and GERD, subjects were divided into three strata: GERD-/NOC+, GERD+/NOC-, and GERD+/NOC+.. A total of 770 subjects were randomized. There was no statistically significant improvement in morning peak expiratory flow (PEF) over placebo in the overall study population: 6.3 L/min (p = 0.061). Over the whole treatment period, in GERD+/NOC+ subjects (n = 350), esomeprazole provided an 8.7-L/min improvement (p = 0.03) in morning PEF, and a 10.2-L/min improvement (p = 0.012) in evening PEF over placebo. Among 307 subjects taking long-acting beta2-agonists, improvements over placebo were observed in morning PEF (12.2 L/min, p = 0.017) and in evening PEF (11.1 L/min, p = 0.024); these improvements were more pronounced in GERD+/NOC+ subjects. Esomeprazole 40 mg twice daily was well tolerated and no safety concerns were noted.. Esomeprazole improved PEF in subjects with asthma who presented with both GERD and NOC. In subjects without both GERD and NOC, no improvement could be detected.

Topics: Administration, Oral; Adolescent; Adult; Aged; Asthma; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Esomeprazole; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Probability; Prognosis; Reference Values; Respiratory Function Tests; Risk Assessment; Severity of Illness Index; Treatment Outcome

The purpose of this study is a comparative assessment of the clinical efficiency of Omeprazole and Esomeprazole in patients suffering from bronchial asthma (BA) with associated gastroesophageal reflux disease (GERD). 101 patients with BA and associated GERD being under study were divided into three groups depending on the way of application of the anti-reflux therapy. Patients from the I group were administered Omeprazole--20 mg per day, patients from the II group received Omeprazole--mg per day, and patients from the III group were administered Esomeprazole--40 mg per day, the treatment courses of each group amounting to eight weeks. The clinical efficiency indices of pulmonary (CEIP) and esophageal (CEIE) symptoms were calculated when the results of the study were summed. The decrease of CEIP and CEIE against the background of the anti-reflux therapy (for example, the CEIP of patients from the III group decreased from 14.9 +/- 1.5 (before the treatment) to 2.9 +/- 0.6 points following eight weeks of treatment (p < 0.001), and the CEIE decreased from 9.0 +/- 1.2 (before the treatment) to 1.7 +/- 0.3 points following eight weeks of treatment (p < 0.001)) has demonstrated the reliable improvement of the clinical course of BA with associated GERD. We failed to discover any essential differences between the impact of Omeprazole in the dose equal to 40 mg per day and the impact of Esomeprazole in the same dose on the CEIP. Thus, the CEIP amounted to 10.1 +/- 1.2 points in the II group and 8.5 +/- 1.4 points in the III group (p > 0.05) after the fourth week of treatment. At the same time, we have discovered a reliable advantage of Esomeprazole as compared with Omeprazole for the improvement of the CEIE. The therapy of BA with associated GERD with Omeprazole in the dose equal to 40 mg per day or Esomeprazole in the dose equal to 40 mg per day contributes to the reliable improvement of both pulmonary and esophageal symptoms, and application of Esomeprazole results in a faster reduction of bronchial obstruction and gastroesophageal reflux.

Topics: Adult; Anti-Ulcer Agents; Asthma; Esomeprazole; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Omeprazole; Time Factors; Treatment Outcome

Topics: Asthma; Case-Control Studies; Esomeprazole; Female; Humans; Lansoprazole; Male; Proton Pump Inhibitors

Topics: Asthma; Biopharmaceutics; Citalopram; Depressive Disorder, Major; Drug Industry; Esomeprazole; Humans; Levalbuterol; Marketing; Stereoisomerism

Topics: Asthma; Esomeprazole; Gastric Acid; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Proton Pump Inhibitors

Topics: Asthma; Esomeprazole; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Proton Pump Inhibitors; Respiratory Aspiration

Topics: Asthma; Esomeprazole; Gastroesophageal Reflux; Humans; Hydrogen-Ion Concentration; Proton Pump Inhibitors; Respiratory Aspiration; Stomach