Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 5 de 5
Filter
1.
COPD ; 12(5): 484-93, 2015.
Article in English | MEDLINE | ID: mdl-25692310

ABSTRACT

The novel long-acting ß2-agonist olodaterol demonstrated an acceptable safety profile in short-term phase II clinical studies. This analysis of four randomized, double-blind, placebo-controlled, parallel-group, phase III studies (1222.11, NCT00782210; 1222.12, NCT00782509; 1222.13, NCT00793624; 1222.14, NCT00796653) evaluated the long-term safety of olodaterol once daily (QD) in a large cohort of patients with moderate to very severe (Global initiative for chronic Obstructive Lung Disease 2-4) chronic obstructive pulmonary disease (COPD). The studies compared olodaterol (5 or 10 µg) QD via Respimat®, formoterol 12 µg twice daily (BID) via Aerolizer® (1222.13 and 1222.14), and placebo for 48 weeks. Patients continued receiving background maintenance therapy, with ∼60% receiving concomitant cardiovascular therapy and 25% having a history of concomitant cardiac disease. Pre-specified analyses of pooled data assessed the adverse events (AEs) and serious AEs in the whole population, and in subgroups with cardiac disease, along with in-depth electrocardiogram and Holter monitoring. In total, 3104 patients were included in the safety analysis: 876 received olodaterol 5 µg, 883 received olodaterol 10 µg, 885 received placebos, and 460 received formoterol 12 µg BID. Overall incidence of on-treatment AEs (71.2%), serious AEs (16.1%), and deaths (1.7%) were balanced across treatment groups. Respiratory and cardiovascular AEs, including major adverse cardiac events, were reported at similar frequencies in placebo and active treatment groups. The safety profiles of both olodaterol 5 µg (marketed and registered dose) and 10 µg QD delivered via Respimat® are comparable to placebo and formoterol BID in this population, with no safety signals identified.


Subject(s)
Adrenergic beta-2 Receptor Agonists/adverse effects , Benzoxazines/adverse effects , Pulmonary Disease, Chronic Obstructive/drug therapy , Adrenergic beta-2 Receptor Agonists/administration & dosage , Aged , Benzoxazines/administration & dosage , Cause of Death , Death, Sudden, Cardiac/epidemiology , Delayed-Action Preparations/administration & dosage , Delayed-Action Preparations/adverse effects , Disease Progression , Drug Administration Schedule , Electrocardiography, Ambulatory , Female , Forced Expiratory Volume , Formoterol Fumarate/administration & dosage , Formoterol Fumarate/adverse effects , Heart Diseases/complications , Heart Diseases/drug therapy , Humans , Hypertension/complications , Hypertension/drug therapy , Male , Metered Dose Inhalers , Middle Aged , Myocardial Infarction/epidemiology , Pulmonary Disease, Chronic Obstructive/complications , Pulmonary Disease, Chronic Obstructive/mortality , Stroke/epidemiology
2.
Article in English | MEDLINE | ID: mdl-24966672

ABSTRACT

BACKGROUND: Olodaterol is a long-acting ß2-agonist with a 24-hour bronchodilator profile. Two replicate, randomized, double-blind, placebo-controlled, parallel-group, Phase III trials were performed as part of a comprehensive clinical program to investigate the long-term safety and efficacy of olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving usual-care background therapy. METHODS: Patients received olodaterol 5 µg or 10 µg or placebo once daily for 48 weeks. Coprimary end points were forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 3 hours (AUC0-3) response (change from baseline), and trough FEV1 response at 12 weeks. Secondary end points included additional lung function assessments, use of rescue medications, FEV1 AUC response from 0 to 12 hours, and Patient Global Rating over 48 weeks. RESULTS: Overall, 624 and 642 patients were evaluated in studies 1222.11 and 1222.12, respectively. In both studies, olodaterol 5 µg and 10 µg significantly improved the FEV1 AUC0-3 response (P<0.0001) and trough FEV1 (study 1222.11, P<0.0001; study 1222.12, P<0.05, post hoc) at week 12, with an incidence of adverse events comparable with that of placebo. Secondary end points supported the efficacy of olodaterol. CONCLUSION: These studies demonstrate the long-term efficacy and safety of once-daily olodaterol 5 µg and 10 µg in patients with moderate to very severe COPD continuing with usual-care maintenance therapy.


Subject(s)
Adrenergic beta-2 Receptor Agonists/administration & dosage , Benzoxazines/administration & dosage , Bronchodilator Agents/administration & dosage , Lung/drug effects , Nebulizers and Vaporizers , Pulmonary Disease, Chronic Obstructive/drug therapy , Administration, Inhalation , Adrenergic beta-2 Receptor Agonists/adverse effects , Aged , Area Under Curve , Asia , Australia , Benzoxazines/adverse effects , Bronchodilator Agents/adverse effects , Double-Blind Method , Equipment Design , Female , Forced Expiratory Volume , Germany , Humans , Lung/physiopathology , Male , Middle Aged , New Zealand , Predictive Value of Tests , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/physiopathology , Severity of Illness Index , Time Factors , Treatment Outcome , United States
3.
Conn Med ; 76(10): 585-7, 2012.
Article in English | MEDLINE | ID: mdl-23243759

ABSTRACT

Splenosis is the autotransplantation of splenic tissue to abnormal sites, either the abdomen or thorax, following traumatic injury of the spleen. For splenic tissue to reach the thorax, there must be concomitant diaphragmatic injury. Thoracic splenosis is usually discovered incidentally on routine thoracic imaging as single or multiple, indeterminate pleural-based masses limited to the left hemithorax. Traditionally, diagnosis required invasive procedures and/or surgery to acquire tissue samples in order to rule out other causes of lung masses, ie, cancer. We report a case in which nuclear imaging was used to make the diagnosis of thoracic splenosis, thus preventing the need for invasive procedures and avoiding unnecessary patient apprehension.


Subject(s)
Radiopharmaceuticals , Splenosis/diagnostic imaging , Technetium Tc 99m Sulfur Colloid , Accidents, Traffic , Adult , Humans , Male , Motorcycles , Radionuclide Imaging , Thoracic Injuries/complications , Wounds, Nonpenetrating/complications
4.
Respir Med ; 105(8): 1195-202, 2011 Aug.
Article in English | MEDLINE | ID: mdl-21439807

ABSTRACT

BACKGROUND: To correctly estimate the cost-effectiveness of treatments that reduce COPD exacerbations, the utility gains from preventing exacerbations need to be measured. This requires utility measurement during exacerbations. AIM: To assess the ability of the EQ-5D to detect the recovery from moderate COPD exacerbations. METHODS: In the US, 65 COPD and/or chronic bronchitis patients (≥40 years old smokers or ex-smokers with a history of 10 pack-years) were enrolled within 48 h of symptom onset of the exacerbation. Patients completed the EQ-5D at enrollment and after 7, 14 and 42 days. Symptoms and medication use were recorded in diaries. Change over time and loss of quality-adjusted life years (QALYs) due to the exacerbation was estimated. Using standardized response mean (SRM) as the metric of responsiveness, we compared the responsiveness of the EQ-5D to the responsiveness of morning peak expiratory flow rate, rescue medication use and symptom scores. SRMs were also used to assess whether patients with greater improvements in peak expiratory flow rate, rescue medication use, symptom scores, clinician global impression of change, and patient global impression of change had a greater improvement in EQ-5D than patients with smaller improvement. RESULTS: Mean utility index scores (standard deviation) using the US value set were 0.683 (0.209), 0.726 (0.216), 0.768 (0.169) and 0.760 (0.181) at days 1, 7, 14 and 42, respectively. The mean of each patient's lowest index score, either at visit 1 or visit 2, was 0.651 (0.213). Over the course of 6 weeks there was a highly significant improvement in mean utility. The greatest improvement was seen between day 7 and day 14. Patients lost on average 0.00896 QALY (0.0086) or 3.27 (3.13) quality-adjusted life days during the exacerbation. The EQ-5D (SRM: 0.653) was more responsive to change than peak expiratory flow (0.269), rescue medication use (0.343) and sputum symptom scores (0.322) and equally responsive as cough (0.587) and dyspnea (0.638) symptom scores. CONCLUSION: The EQ-5D is responsive to the recovery from a moderate COPD exacerbation.


Subject(s)
Activities of Daily Living , Forced Expiratory Volume/physiology , Pulmonary Disease, Chronic Obstructive/physiopathology , Quality of Life , Surveys and Questionnaires , Vital Capacity/physiology , Cost-Benefit Analysis , Disease Progression , Female , Forced Expiratory Volume/drug effects , Humans , Male , Middle Aged , Pain Measurement , Prospective Studies , Psychometrics , Recovery of Function/physiology , Severity of Illness Index , Sickness Impact Profile , Vital Capacity/drug effects
5.
Respir Med ; 104(4): 534-41, 2010 Apr.
Article in English | MEDLINE | ID: mdl-19917525

ABSTRACT

BACKGROUND: To assess the responsiveness of the Cough and Sputum Assessment Questionnaire (CASA-Q) in COPD and chronic bronchitis patients recovering from an acute exacerbation. The 20-item questionnaire with a 7-day recall assesses the frequency and severity of cough and sputum and their impact on everyday life in clinical (trial) settings. The four domains (cough/sputum symptom and impact) use scales from 0 to 100, with lower scores indicating higher symptom/impact levels. METHODS: Outpatients were enrolled within 48h of symptom onset of their exacerbation. Treatment was initiated at the discretion of the investigator, and patients observed for 6 weeks. During study visits, 59 eligible patients completed the CASA-Q at enrolment, week 1, 2 and 6. Responsiveness was assessed by calculating standardized effect sizes. RESULTS: Of the 19 male and 40 female patients with a mean (standard deviation, SD) age of 61.1 (10.5) years, all were classified by their physician to have improved or recovered after six weeks. The mean (SD) CASA-Q sores for the cough symptom, cough impact, sputum symptom and sputum impact domains increased from 32.6 (21.0), 40.7 (22.4), 37.4 (20.1), 47.1 (24.2) at enrolment to 54.0 (19.8), 63.7 (21.3), 55.1 (19.0), 65.5 (20.5) at week 6, respectively. Standardized effect sizes for patients improved or recovered from their exacerbation at week 6 were above 1.0 for the cough domains and at least 0.77 for the sputum domains. CONCLUSIONS: The CASA-Q was responsive to symptom changes in patients recovering from an exacerbation.


Subject(s)
Bronchitis, Chronic/complications , Cough/drug therapy , Pulmonary Disease, Chronic Obstructive/complications , Sputum/metabolism , Surveys and Questionnaires , Bronchitis, Chronic/drug therapy , Bronchitis, Chronic/physiopathology , Cough/etiology , Disease Progression , Female , Health Status Indicators , Humans , Male , Middle Aged , Pulmonary Disease, Chronic Obstructive/drug therapy , Pulmonary Disease, Chronic Obstructive/physiopathology , Quality of Life , Severity of Illness Index , Treatment Outcome
SELECTION OF CITATIONS
SEARCH DETAIL
...