budesonide--formoterol-fumarate-drug-combination and Airway-Obstruction

Although it has not been evaluated prospectively, the usual treatment for obstructive airway disease after allogeneic hematopoietic stem cell transplantation, which is related to graft versus host disease, consists of intensification of systemic immunosuppressive therapy. However, this treatment has a limited efficacy and is associated with a significant number of serious adverse effects, particularly infectious. Alternative treatments are therefore required. Recently, clinical and functional improvement in patients with obstructive airway disease following allogenic hematopoietic stem cell transplantation treated with inhaled combined Budesonide/Formoterol has been retrospectively reported.. The present prospective multi-centered, randomised double-blind trial is designed to evaluate the efficacy of the combination of budesonide/formoterol (400/12 microg 2 inhalations bid) versus placebo in patients with moderate to severe obstructive airway disease, not requiring initiation or intensification of systemic immunosuppressive therapy for extra thoracic graft versus host disease. The primary outcome will be the improvement of FEV1 at 1 month of treatment. The secondary outcomes will be the clinical and functional pulmonary improvements at 6 months.. The leading hypothesis is that patients treated with inhaled combined Budesonide/Formoterol will show significant improvement of their clinical symptoms and pulmonary functional testing.

Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Airway Obstruction; Anti-Asthmatic Agents; Bronchodilator Agents; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Drug Combinations; Dyspnea; Ethanolamines; Follow-Up Studies; Formoterol Fumarate; Glucocorticoids; Hematopoietic Stem Cell Transplantation; Humans; Lung Diseases, Obstructive; Placebos; Prospective Studies; Respiratory Function Tests; Statistics, Nonparametric; Time Factors; Transplantation, Homologous; Treatment Outcome

Data on the onset of action of COPD medications are lacking. This study compared the onset of bronchodilation following different inhaled therapies in patients with moderate-to-severe COPD and reversible airway obstruction.. In this double-blind, double-dummy, crossover study, 90 patients (aged >or=40 years; FEV(1) 30-70% predicted) were randomized to a single dose (two inhalations) of budesonide/formoterol 160/4.5 microg, salmeterol/fluticasone 25/250 microg, salbutamol 100 microg or placebo (via pressurized metered-dose inhalers) on four visits. The primary end-point was change in FEV(1) 5 min after drug inhalation; secondary end-points included inspiratory capacity (IC) and perception of onset of effect.. Budesonide/formoterol significantly improved FEV(1) at 5 min compared with placebo (P < 0.0001) and salmeterol/fluticasone (P = 0.0001). Significant differences were first observed at 3 min. Onset of effect was similar with budesonide/formoterol and salbutamol. Improvements in FEV(1) following active treatments were superior to placebo after 180 min (all P < 0.0001); both combinations were better than salbutamol at maintaining FEV(1) improvements (P

Topics: Adrenal Cortex Hormones; Adult; Aged; Airway Obstruction; Albuterol; Androstadienes; Anti-Asthmatic Agents; Bronchodilator Agents; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Cross-Over Studies; Double-Blind Method; Drug Combinations; Ethanolamines; Female; Fluticasone-Salmeterol Drug Combination; Forced Expiratory Volume; Humans; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Spirometry; Time Factors

Patients with asthma present structural and inflammatory alterations that are believed to play a role in disease severity. However, airway remodeling and inflammation have not been extensively investigated in relation to both symptom control and airflow obstruction in severe asthmatics. We aimed to investigate several inflammatory and structural pathological features in bronchial biopsies of severe asthmatics that could be related to symptom control and airflow obstruction after standardized treatment.. Fifty severe asthmatics received prednisone 40 mg/d for 2 weeks and maintenance therapy with budesonide/formoterol 400/12 μg twice daily + budesonide/formoterol 200/6 μg as needed for 12 weeks. Endobronchial biopsies were performed at the end of 12 weeks. We performed extensive immunopathological analyses of airway tissue inflammation and remodeling features in patients stratified by asthma symptom control and by airflow obstruction.. Airway tissue inflammation and remodeling were not associated with symptom control. Asthmatics with persistent airflow obstruction had greater airway smooth muscle (Asm) area with decreased periostin and transforming growth factor beta-positive cells within Asm bundles, in addition to lower numbers of chymase-positive mast cells in the submucosa compared to patients with nonpersistent obstruction.. Symptom control in severe asthmatics was not associated with airway tissue inflammation and remodeling, although persistent airflow obstruction in these patients was associated with bronchial inflammation and airway structural changes.

Topics: Adult; Airway Obstruction; Airway Remodeling; Anti-Asthmatic Agents; Asthma; Bronchi; Budesonide, Formoterol Fumarate Drug Combination; Female; Humans; Inflammation; Male; Middle Aged; Prednisone

The use of a combination inhaler containing budesonide and formoterol (BUD/FOR) to both maintenance and quick relief therapy has been recommended as an improved method of using inhaled corticosteroid/long-acting β agonist therapy. The aim of this study was to investigate the acute effects of BUD/FOR and testing the availability of BUD/FOR for early reversibility test in patients with airway obstruction.. The study was conducted on patients who were admitted to the Department of Pulmonary Medicine, Samsun Medical Park Hospital, Samsun, Turkey.. A total of 44 patients were included in the study. The mean age of patients was 48.5 ± 17.3 (range 10-75) years and the male-to-female ratio was 36:8. The pre-bronchodilator pulmonary function test results are as follows: the mean forced vital capacity, 3,025 ± 1,162 mL (76.3% ± 23.2%); mean forced expiratory volume in 1 second (FEV1), 1,898 ± 725 mL (59.2% ± 19.1%); mean FEV1/forced vital capacity, 62.8 ± 6.3% (range 42%-70%); mean peak expiratory flow, 3,859 ± 1,779 mL (48.0% ± 19.7%); and forced expiratory flow 25%-75%, 1,295 ± 486 mL (35.8% ± 12.3%). The reversibility was positive in 26 (59.1%) patients. The absolute change and percentage of change in FEV1 were 318 ± 228 mL and 17.7% ± 11.9%, respectively. The patients were divided into two groups according to reversibility (reversible and irreversible) and both groups were compared with changes according to spirometric results. FEV1 values were statistically different between the two groups.. The fixed combination of BUD/FOR has rapid bronchodilator effect, and they can be used for early reversibility test.

Topics: Administration, Inhalation; Adolescent; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Airway Obstruction; Asthma; Bronchoconstriction; Bronchodilator Agents; Budesonide, Formoterol Fumarate Drug Combination; Child; Female; Forced Expiratory Volume; Glucocorticoids; Humans; Lung; Male; Middle Aged; Nebulizers and Vaporizers; Pulmonary Disease, Chronic Obstructive; Spirometry; Time Factors; Treatment Outcome; Turkey; Vital Capacity; Young Adult