pulmicort and Headache

The objective of the present study was to evaluate the clinical response to topical budesonide in patients with nasal polyposis (NP) and to evaluate if there is any clinical event that may predict the response to treatment. Twenty patients with NP were assessed by a clinical questionnaire, nasal endoscopy and sinusal computed tomography. The patients were then medicated with budesonide, 256 microg/nostril/day, for a 2-month period and afterwards they were submitted to a new clinical questionnaire and a new endoscopy. Post-treatment endoscopy revealed a significant reduction of polyp size's score (4.25 vs. 2.90, p < 0.01), which was associated to improvement of nasal symptoms: posterior rhinorrhea, headache, hyposmia, anterior rhinorrhea, and sneezing (p < 0.05). There was also a significant improvement of the sum of scores (20.10 vs. 10.30, p < 0.0001). Cacosmia and nasal itching did not respond to medical treatment. Patients with a higher tomographic extension of the polyp presented a significantly worse clinical response (p < 0.05). We conclude that there was partial, but significant, improvement of nasal symptoms and polyp size after treatment with nasal budesonide and that this clinical improvement was inversely correlated to the tomographic extension of NP at diagnosis.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Endoscopy; Female; Glucocorticoids; Headache; Humans; Male; Middle Aged; Nasal Obstruction; Nasal Polyps; Olfaction Disorders; Paranasal Sinuses; Remission Induction; Rhinitis; Sneezing; Surveys and Questionnaires; Tomography, X-Ray Computed; Treatment Outcome

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

The impending phaseout of chlorofluorocarbons as propellants in pressurized metered-dose inhalers used in the treatment of asthma has resulted in the development of alternative devices to deliver drug to the pulmonary airways. These alternative devices include metered-dose inhalers using environmentally friendly hydroflurocarbon propellants and breath-actuated dry-powder inhalers. The purpose of this study was to compare the single- and multiple-dose pharmacokinetics, pharmacodynamics, and tolerability of a newly developed hydroflurocarbon formulation of triamcinolone acetonide (Azmacort HFA 225 mcg Inhalation Aerosol) to that of the dry-powder formulation of budesonide (Pulmicort Turbuhaler 200 mcg). This three-way crossover study used 18 normal healthy subjects each receiving a 675 mcg dose of triamcinolone acetonide, 600 mcg dose of budesonide, or placebo twice a day for 5 days. Serial plasma samples were collected after the first and last dose of test medication for pharmacokinetic analysis. Pharmacodynamics were assessed by changes in hypothalamic-pituitary-adrenal axis function as measured by 8 a.m. serum cortisol, 24-hour overnight serum cortisol AUC(0-24), and 24-hour urinary-free cortisol after the last evening dose of test drug. Tolerability was assessed through physical examinations, vital signs, 12-lead ECG, routine clinical labs, and adverse events recording. Both compounds were systemically absorbed. However, no significant drug accumulation was noted with chronic dosing. Chronic dosing did result in a statistically significant 20% reduction in basal 24-hour serum cortisol AUC(0-24) for both compounds. There were no clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, or routine clinical labs noted during the study. Overall, the study drugs were well tolerated, with adverse events characterized as mild to moderate in severity.

Topics: Administration, Inhalation; Adolescent; Adult; Aerosol Propellants; Analysis of Variance; Anti-Inflammatory Agents; Area Under Curve; Blood Pressure; Budesonide; Cross-Over Studies; Diarrhea; Dizziness; Dose-Response Relationship, Drug; Electrocardiography; Headache; Humans; Hydrocarbons, Fluorinated; Hydrocortisone; Male; Nebulizers and Vaporizers; Pulse; Triamcinolone Acetonide

Optimal management of chronic, mild-to-moderate asthma with inhaled steroids may include use of the lowest possible doses, as recommended in guidelines, and a reduction in the frequency of daily administration for greater convenience. Lower doses and once daily treatment with inhaled steroids must be rigorously evaluated in controlled clinical trials.. The objective of this study was to assess the efficacy and safety of once daily treatment with budesonide in subjects with stable asthma.. Once daily budesonide was assessed in 309 adult subjects, including those who were and were not using an inhaled steroid at baseline. The subjects were stratified by inhaled steroid use and randomly assigned to one of 3 treatments: 200 microgram budesonide, 400 microgram budesonide, or placebo administered by means of Turbuhaler once daily in the morning for 6 weeks. Beyond this point, treatment was continued unchanged for another 12 weeks (maintenance) in those receiving 200 microgram budesonide once daily and placebo. In those who received 400 microgram budesonide once daily, the dose was reduced to 200 microgram once daily at week 6 and held constant for the remaining 12 weeks (400/200 microgram group). Primary efficacy endpoints were mean change from baseline in FEV1 and morning peak expiratory flow.. Once daily budesonide was well tolerated and resulted in significant improvements in all efficacy endpoints, even though baselines were well stabilized. Baseline lung function was elevated with little room for improvement; however, mean increases in FEV1 during the maintenance period were 0.10 L and 0.11 L in the 200 microgram and 400/200 microgram groups, respectively, versus a decrease of -0.09 L in the placebo arm (P <.001). Results for peak expiratory flow were similar. Significant improvements in secondary endpoints, including symptoms, beta-agonist use, and quality of life, also developed with budesonide 200 and 400 microgram once daily.. Inhaled budesonide, in doses as low as 200 microgram, may be an appropriate introductory or maintenance dose in subjects with stable, mild-to-moderate asthma.

Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Aged; Anti-Inflammatory Agents; Asthma; Bronchial Spasm; Budesonide; Dose-Response Relationship, Drug; Double-Blind Method; Female; Headache; Humans; Male; Middle Aged; Quality of Life; Respiratory Function Tests; Respiratory Tract Infections

The goal of this study is to evaluate the safety and efficacy of Small intestinal release mesalamine (SIRM) for symptom relief in refractory celiac disease (RCD).. Therapeutic options for the RCD are inadequate and treatment with corticosteroids and immunosuppressants is limited by side effects. SIRM has been shown to have local antiinflammatory action and excellent tolerability.. We reviewed records of the RCD patients who received SIRM in an open-label therapeutic trial. Data included demographics, disease characteristics, dose and duration of SIRM therapy, and response. Response was categorized as complete if there was complete resolution of symptoms, partial if there was at least 50% improvement, and nonresponsive if there was less than 50% improvement.. Four patients were treated with SIRM alone and 6 received SIRM and oral budesonide. Within 4 weeks, 50% had complete response and an additional 10% had partial response. Two of the 6 patients were able to discontinue budesonide. One patient discontinued SIRM owing to headaches.. SIRM seems to be a safe and efficacious treatment option in patients with RCD. Larger, controlled trials of this agent are warranted.

Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Budesonide; Celiac Disease; Female; Glucocorticoids; Headache; Humans; Intestine, Small; Male; Mesalamine; Middle Aged; Treatment Outcome

Inhalation steroid therapy can cause ocular hypertension or open angle glaucoma. The authors describe the case of a young girl who presented with raised intraocular pressure and headaches due to the prolonged administration of nasal and inhalation steroids. The ophthalmologist should monitor the intraocular pressure in patients who use inhalation or nasal steroid therapy on a regular base. The physician or paediatrician should be aware of this complication in children with headaches or diminished visual acuity.

Topics: Administration, Inhalation; Asthma; Budesonide; Child; Female; Headache; Humans; Intraocular Pressure; Ocular Hypertension