Assessment of Consistency of Fixed Airflow Obstruction Status during Budesonide/Formoterol Treatment and Its Effects on Treatment Outcomes in Patients with Asthma

BackgroundThe consistency of fixed airflow limitation status during treatment in patients with asthma is unknown.ObjectiveThe objective of this study was to determine the consistency of fixed airflow obstruction (FAO) status during treatment and effects on treatment response.MethodsThis post hoc analysis from a 12-week study (NCT00652002) assessed patients aged 12 years or more with moderate-to-severe asthma randomized to twice-daily budesonide/formoterol (BUD/FM) via pressurized metered-dose inhaler (pMDI) 320/9 μg, BUD pMDI 320 μg, FM 9 μg via dry-powder inhaler, or placebo. FAO status was assessed postbronchodilator at screening and after study drug administration at weeks 2, 6, and 12 via the forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) ratio < lower limit of normal (LLN) (FAO+) or ≥ LLN (FAO−). Patients with persistent FAO− and FAO+ retained their screening FAO status at all visits. Patients with inconsistent FAO changed categories at least once during the study. Assessments included early withdrawal due to predefined worsening asthma events (PAEs), lung function, and symptoms.ResultsOf 386 patients, 29% had persistent FAO+, 31% inconsistent FAO, and 40% persistent FAO−. PAEs were lowest in the FAO− group overall and with BUD/FM treatment in patients with FAO+ and inconsistent FAO. Baseline demographics and treatment responses of the inconsistent FAO group were most similar to the FAO+ group. The greatest improvements in asthma control days and use of rescue medications were seen with BUD/FM treatment, regardless of FAO status.ConclusionsApproximately one third of patients with moderate-to-severe asthma in this study had inconsistent FAO, and their treatment responses were most similar to patients with FAO+. Regardless of FAO status, patients treated with BUD/FM experienced the most improved treatment responses and fewest withdrawals due to PAEs

Assessment of asthma control and asthma exacerbations in the epidemiology and natural history of asthma: outcomes and treatment regimens (TENOR) observational cohort

Patients with severe or difficult-to-treat asthma account for substantial asthma morbidity, mortality, and healthcare burden despite comprising only a small proportion of the total asthma population. TENOR, a multicenter, observational, prospective cohort study was initiated in 2001. It enrolled 4,756 adults, adolescents and children with severe or difficult-to-treat asthma who were followed semi-annually and annually for three years, enabling insight to be gained into this understudied population. A broad range of demographic, clinical, and patient self-reported assessments were completed during the follow-up period. Here, we present key findings from the TENOR registry in relation to asthma control and exacerbations, including the identification of specific subgroups found to be at particularly high-risk. Identification of the factors and subgroups associated with poor asthma control and increased risk of exacerbations can help physicians design individual asthma management, and improve asthma-related health outcomes for these patients

A Review of the Role of Inhaled Corticosteroids in the Treatment of Acute Asthma A Review of the Role of Inhaled Corticosteroids in the Treatment of Acute Asthma

Summary: Systemic corticosteroids (CSs) are generally accepted as treatment for acute exacerbations of asthma. In contrast, inhaled corticosteroids (ICs) have been used for the long-term management of asthma but are not widely accepted for the treatment of asthma exacerbations. The onset of action of ICs in acute asthma begins in 1 hour. In patients with mild to moderate exacerbation, administration of high-dose ICs may decrease the need for hospital admission and the number of symptomatic days

Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. Reply

No abstract availabl

Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged ≥4 years with moderate-to-severe asthma: rationale and design of the randomised, double-blind, active-controlled MANDALA study

Introduction: Uncontrolled asthma is associated with substantial morbidity. While fast-acting bronchodilators provide quick relief from asthma symptoms, their use as rescue fails to address the underlying inflammation. Combining a short-acting beta2-agonist, such as albuterol (salbutamol), with an inhaled corticosteroid, such as budesonide, in a single inhaler as rescue therapy could help control both bronchoconstriction and inflammation, and reduce the risk of asthma exacerbations. Methods and analysis: The Phase 3 MANDALA study was designed to determine the efficacy of albuterol in combination with budesonide (albuterol/budesonide 180/160 µg or 180/80 µg, two actuations of 90/80 µg or 90/40 µg, respectively) versus albuterol (180 µg, two actuations of 90 µg) as rescue therapy in adult, adolescent and paediatric patients with moderate-to-severe asthma. This event-driven study enrolled symptomatic patients (3000 adults/adolescents and 100 children aged 4-11 years) who experienced ≥1 severe asthma exacerbation in the previous year and were receiving maintenance therapy for ≥3 months prior to study entry. The primary efficacy endpoint was time-to-first severe asthma exacerbation. Ethics and dissemination: The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and Good Clinical Practice and the applicable regulatory requirements

Albuterol/budesonide for the treatment of exercise-induced bronchoconstriction in patients with asthma: the TYREE study

none9siBackground: PT027 is a fixed-dose combination of albuterol (salbutamol) and budesonide in a single pressurized metered dose inhaler. Objective: To assess the efficacy and safety of albuterol/budesonide compared with placebo in patients with asthma and exercise-induced bronchoconstriction (EIB). Methods: In this randomized, double-blind, 2-period, single-dose crossover study, adolescents and adults with asthma and EIB (defined by ≥20% decrease from pre-exercise challenge FEV 1) were randomized to albuterol/budesonide (180/160 µg) followed by placebo (n=29) or the reverse sequence (n=31). Subjects were stratified by background therapy (as-needed short-acting β 2 -agonist [SABA] alone or low- to medium-dose inhaled corticosteroid [ICS] plus as-needed SABA). FEV 1 was measured 5 minutes pre-dose, 30 minutes post-dose (5 minutes pre-exercise challenge [baseline]), and 5, 10, 15, 30 and 60 minutes post-exercise. The primary endpoint was maximum percentage fall from baseline in FEV 1 up to 60 minutes postexercise challenge. Results: Least squares mean maximum percentage fall in FEV 1 up to 60 minutes postexercise challenge was 5.45% with albuterol/budesonide versus 18.97% with placebo (difference -13.51% [95% CI: -16.94%, -10.09%]; p&lt;0.001). More subjects were fully protected (maximum percentage fall in FEV 1 post-exercise challenge &lt;10%) with albuterol/budesonide than with placebo (78.3% vs 28.3%; p&lt;0.001). The treatment effect was consistent irrespective of background ICS therapy, and albuterol/budesonide was well tolerated. Conclusion: In adolescents and adults with asthma and EIB, a single dose of albuterol/budesonide 180/160 µg taken approximately 30 minutes prior to exercise was significantly more effective than placebo in preventing EIB.noneLaForce, Craig; Chipps, Bradley E; Albers, Frank C; Reilly, Laurence; Johnsson, Eva; Andrews, Helen; Cappelletti, Christy; Maes, Andrea; Papi, AlbertoLaforce, Craig; Chipps, Bradley E; Albers, Frank C; Reilly, Laurence; Johnsson, Eva; Andrews, Helen; Cappelletti, Christy; Maes, Andrea; Papi, Albert