pulmicort and Fatigue

Assessment of patients with COPD has changed in the last few years by adding subjective patient evaluations to traditional measurements based on pulmonary function. One of the most recently studied variables is symptom variability during the day and, specifically, patients' perceptions of these symptoms in the first few hours of the day. To evaluate this feature, two new symptom questionnaires, the Capacity of Daily Living in the Morning (CDLM) questionnaire and the Global Chest Symptoms Questionnaire (GCSQ), have recently been developed. Recent studies have begun to provide data on the effect of the available treatments on these morning symptoms, yielding information on the rapidity of action of budesonide/formoterol with a significant and nearly clinically relevant effect on morning activities. Confirmation of these results could lead to future strategies designed to earlier symptomatic improvement, which could lead to greater treatment adherence.

Topics: Activities of Daily Living; Adrenergic beta-2 Receptor Agonists; Anti-Inflammatory Agents; Bronchodilator Agents; Budesonide; Diagnostic Self Evaluation; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Dyspnea; Ethanolamines; Fatigue; Formoterol Fumarate; Humans; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic; Severity of Illness Index; Surveys and Questionnaires

Preclinical studies suggest that inhaled budesonide may be an effective chemopreventive agent for lung cancer. We conducted a phase IIb study to determine the effects of inhaled budesonide in smokers with bronchial dysplasia.. A total of 112 smokers with more than or equal to one site of bronchial dysplasia > 1.2 mm in size identified by autofluorescence bronchoscopy-directed biopsy was randomly assigned to receive placebo or budesonide (Pulmicort Turbuhaler) 800 microg twice daily inhalation for 6 months. The primary end point was change in the histopathologic grade on repeat biopsy of the same sites at the end of 6 months.. There were no significant differences in the regression or progression rates of bronchial dysplasia between the two groups. There was a statistically significant but modest decrease in p53 and BclII expression in the bronchial biopsies after 6 months of Pulmicort Turbuhaler versus placebo (P = 0.01 and P = 0.001, respectively). There was a small but statistically significant decrease in the proportion of computed tomography-detected lung nodules after Pulmicort Turbuhaler compared with placebo (P = 0.024).. Our results suggest that in smokers, inhaled budesonide in the dose of 1600 microg daily for 6 months had no effect in regression of bronchial dysplastic lesions or prevention of new lesions. Budesonide treatment resulted in a modest decrease in p53 and BclII protein expression in bronchial biopsies and a slightly higher rate of resolution of computed tomography-detected lung nodules. Whether budesonide truly has an effect in preneoplastic lesions in the peripheral airways and alveoli requires additional investigation.

Topics: Administration, Inhalation; Adult; Aged; Biopsy; Bronchi; Bronchodilator Agents; Budesonide; Cough; Double-Blind Method; Fatigue; Female; Headache; Humans; Immunohistochemistry; Ki-67 Antigen; Logistic Models; Male; Middle Aged; Pharynx; Precancerous Conditions; Proto-Oncogene Proteins c-bcl-2; Respiratory Mucosa; Treatment Outcome; Tumor Suppressor Protein p53

PSC has characteristics of an (auto)immune-mediated disease: however, few studies have evaluated corticosteroid therapy for this disorder.. We performed an 8-wk double-blind randomized pilot study to assess the effects of additional treatment with 9 mg budesonide (n = 6) versus 3 mg budesonide (n = 6) versus 10 mg prednisone (n = 6) in patients who had been treated with UDCA (mean dose, 12 mg/kg/day) for at least 5 months without achieving biochemical remission. Pruritus and fatigue were evaluated using visual analog scales. Serum liver biochemistry was measured every 4 wk. At entry and at the end of the trial, adrenocorticotrophic hormone (ACTH) and dehydroepiandrosterone (DHEA) were measured to assess effects on the pituitary-adrenal axis. Duodenal bile was collected for assessment of biliary corticosteroid activity.. Pruritus decreased significantly more in the prednisone group compared to both the 3-mg and the 9-mg budesonide groups (p < 0.05). Alkaline phosphatase (mean: -23.4%; p = 0.03) and IgG (mean: -16.2%; p = 0.04) decreased in the prednisone group, whereas bilirubin, gamma-glutamyl transferase, aspartate aminotransferase, and alanine aminotransferase did not change significantly. No significant clinical or liver biochemical changes were observed in the 3-mg and 9-mg budesonide groups. Significantly larger drops in serum ACTH were found in the 10-mg prednisone group (-40.7%; p = 0.04) and 9-mg budesonide group (-36.6%; p = 0.02) compared to the 3-mg budesonide group (+ 19.0%). No significant differences in percentage change in baseline values for DHEA between the three treatment arms were found. Mononuclear cell proliferation assays did not demonstrate corticosteroid activity in bile. Autoimmune hepatitis was observed in one case (9 mg budesonide) when corticosteroids were tapered off.. The results of this pilot study suggest only minor beneficial short-term effects of prednisone but not budesonide on symptoms and serum liver tests in UDCA-treated PSC patients.

Topics: Adrenal Cortex Hormones; Adrenocorticotropic Hormone; Adult; Alkaline Phosphatase; Anti-Inflammatory Agents; Bile; Budesonide; Cholagogues and Choleretics; Cholangitis, Sclerosing; Double-Blind Method; Fatigue; Female; Humans; Immunoglobulin G; Male; Middle Aged; Pilot Projects; Prednisone; Pruritus; Ursodeoxycholic Acid