fluticasone-propionate--salmeterol-xinafoate-drug-combination and Bronchitis--Chronic

Roflumilast, a once-daily, selective phosphodiesterase-4 inhibitor, reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The RE(2)SPOND study is examining whether roflumilast, when added to an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fixed-dose combination (FDC), further reduces exacerbations. The methodology is described herein.. In this Phase IV, multicenter, double-blind, placebo-controlled, parallel-group trial, participants were randomized 1:1 (stratified by long-acting muscarinic antagonist use) to receive roflumilast or placebo, plus ICS/LABA FDC, for 52 weeks. Eligible participants had severe COPD associated with chronic bronchitis, had two or more moderate-severe exacerbations within 12 months, and were receiving ICS/LABA FDC for ≥3 months. The primary efficacy measure is the rate of moderate or severe COPD exacerbations per participant per year. The secondary efficacy outcomes include mean change in prebronchodilator forced expiratory volume in 1 second (FEV1) over 52 weeks, rate of severe exacerbations, and rate of moderate, severe, or antibiotic-treated exacerbations. Additional assessments include spirometry, rescue medication use, the COPD assessment test, daily symptoms using the EXACT-Respiratory symptoms (E-RS) questionnaire, all-cause and COPD-related hospitalizations, and safety and pharmacokinetic measures.. Across 17 countries, 2,354 participants were randomized from September 2011 to October 2014. Enrollment goal was met in October 2014, and study completion occurred in June 2016.. This study will further characterize the effects of roflumilast added to ICS/LABA on exacerbation rates, lung function, and health of severe-very severe COPD participants at risk of further exacerbations. The results will determine the clinical benefits of roflumilast combined with standard-of-care inhaled COPD treatment.

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Aged; Aminopyridines; Benzamides; Bronchitis, Chronic; Bronchodilator Agents; Budesonide, Formoterol Fumarate Drug Combination; Cyclopropanes; Disease Progression; Double-Blind Method; Female; Fluticasone-Salmeterol Drug Combination; Forced Expiratory Volume; Humans; Lung; Male; Middle Aged; Phosphodiesterase 4 Inhibitors; Pulmonary Disease, Chronic Obstructive; Research Design; Severity of Illness Index; Spirometry; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vital Capacity

Chronic obstructive pulmonary disease (COPD) is recognized as a major healthcare problem in the United States and around the world.. This survey regarding initial experience in patients with COPD collected feedback about newly initiated therapy with fluticasone propionate/salmeterol (FSC; ADVAIR DISKUS).. Three telephone surveys were conducted; Survey 1 prior to initiating therapy with FSC 250/50, and Surveys 2 and 3 at 2 weeks and 30 days after initiating therapy with FSC 250/50, respectively.. One thousand primary care physicians recruited outpatients into the trial.. Patients were either newly diagnosed with COPD associated with chronic bronchitis or were still experiencing breathing difficulties on an anticholinergic medication.. Patients initiated FSC 250/50 and received a 1-month supply of FSC 250/50 with an albuterol inhaler for rescue use.. Outcome measures were patient perceptions of satisfaction, compliance, and convenience and changes in breathing on 1 (negative) to 9 (positive) point scales.. Five hundred sixteen patients completed all 3 surveys. The mean age was 61 years, 63% were female, and 62% had been diagnosed with COPD associated with chronic bronchitis for 3 years or less (Table 1).. Patients reported high satisfaction, compliance, and convenience with FSC 250/50 within 2 weeks of initiating therapy, all maintained over the trial period. Additionally, patients had positive changes in breathing, including improvements in the ability to breathe upon awakening in the morning.

Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchitis, Chronic; Drug Combinations; Female; Fluticasone-Salmeterol Drug Combination; Humans; Male; Middle Aged; Patient Satisfaction; Pulmonary Disease, Chronic Obstructive