Assessing Asthma Symptoms in Adolescents and Adults: Qualitative Research Supporting Development of the Asthma Daily Symptom Diary.

BACKGROUND: Despite the widespread availability of patient-reported asthma questionnaires, instruments developed in accordance with present regulatory expectations are lacking. To address this gap, the Patient-Reported Outcome (PRO) Consortium's Asthma Working Group has developed a patient-reported asthma daily symptom diary (ADSD) for use in clinical research to assess outcomes and support medical product labeling claims in adults and adolescents with asthma. OBJECTIVES: To summarize the qualitative research conducted to inform the initial development of the ADSD and to provide evidence for content validity of the instrument in accordance with the Food and Drug Administration's PRO Guidance. METHODS: Research informing the initial development and confirming the content validity of the ADSD is summarized. This comprised a review of published qualitative research, semi-structured concept elicitation interviews (n = 55), and cognitive interviews (n = 65) with a diverse and representative sample of adults and adolescents with a clinician-confirmed diagnosis of asthma in the United States to understand the asthma symptom experience and to assess the relevance and understanding of the newly developed ADSD. RESULTS: From the qualitative literature review and concept elicitation interviews, eight core asthma symptoms emerged. These were broadly categorized as breathing symptoms (difficulty breathing, shortness of breath, and wheezing), chest symptoms (chest tightness, chest pain, and pressure/weight on chest), and cough symptoms (cough and the presence of mucus/phlegm). Conceptual saturation was achieved and differences in the experience of participants according to socio-demographic or clinical characteristics were not observed. Subsequent testing of the ADSD confirmed participant relevance and understanding. CONCLUSIONS: The ADSD is a new patient-reported asthma symptom diary developed in accordance with the Food and Drug Administration's PRO Guidance. Evidence to date supports the content validity of the instrument. Item performance, reliability, and construct validity will be assessed in future quantitative research.

Exercise-induced bronchospasm, asthma control, and obesity.

Exercise-induced bronchospasm (EIB) commonly affects patients with asthma. However, the relationship between EIB and asthma control remains unclear. Exercise limitation due to asthma might lead to reduced physical activity, but little information is available regarding obesity and EIB in asthma. A recent survey evaluated the frequency of EIB and exercise-related respiratory symptoms in a large number of patients with asthma. The survey results were reanalyzed to address any relationship between EIB and asthma control and obesity. A nationwide random sample of children aged 4-12 years (n = 250), adolescents aged 13-17 years (n = 266), and adults aged ≥18 years (n = 1001) with asthma were interviewed by telephone. Questions in the survey addressed asthma symptoms in general, medication use, and height and weight. Asthma control was categorized using established methods in the Expert Panel Report 3. Body mass index (BMI) was calculated using standard nomograms and obesity was defined as a BMI ≥ 30 kg/m(2). Most children (77.6%), adolescents (71.1%), and adults (83.1%) had either "not well" or "very poorly" controlled asthma. Children with "not well" controlled asthma reported a history of EIB significantly more often than those with "well" controlled" asthma. Asthma patients of all ages who had "not well" and "very poorly" controlled asthma described multiple (four or more) exercise-related respiratory symptoms significantly more often than those with "well-controlled" asthma. Obesity was significantly more common in adolescents with "not well" and "very poorly" controlled asthma and adults with "very poorly" controlled asthma. Children, adolescents, and adults with asthma infrequently have well-controlled disease. A history of EIB and exercise-related respiratory symptoms occur more commonly in patients with not well and very poorly controlled asthma. Obesity was found more often in adolescents and adults, but not children, with asthma, which was not well and very poorly controlled.

Asthma outcomes: composite scores of asthma control.

BACKGROUND: Current asthma guidelines recommend assessing the level of a patient's asthma control. Consequently, there is increasing use of asthma control as an outcome measure in clinical research studies. Several composite assessment instruments have been developed to measure asthma control. OBJECTIVE: National Institutes of Health institutes and federal agencies convened an expert group to propose the most appropriate standardized composite score of asthma control instruments to be used in future asthma studies. METHODS: We conducted a comprehensive search of PubMed using both the National Library of Medicine's Medical Subject Headings and key terms to identify studies that attempted to develop and/or test composite score instruments for asthma control. We classified instruments as core (required in future studies), supplemental (used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at a National Institutes of Health-organized workshop convened in March 2010 and finalized in September 2011. RESULTS: We identified 17 composite score instruments with published validation information; all had comparable content. Eight instruments demonstrated responsiveness over time; 3 demonstrated responsiveness to treatment. A minimal clinically important difference has been established for 3 instruments. The instruments have demographic limitations; some are proprietary, and their use could be limited by cost. CONCLUSION: Two asthma composite score instruments are sufficiently validated for use in adult populations, but additional research is necessary to validate their use in nonwhite populations. Gaps also exist in validating instruments for pediatric populations.

Asthma management and control in the United States: results of the 2009 Asthma Insight and Management survey.

Past asthma surveys have shown suboptimal management and control of asthma in the United States. No major survey of asthma management has been conducted since the Third Expert Panel Report for the National Asthma Education and Prevention Program (NAEPP) guidelines on diagnosis and treatment of asthma (August 2007). This study was designed to report asthma management and control results from the Asthma Insight and Management survey of U.S. patients and physicians. A telephone-based survey was conducted during 2009 in 2500 patients with asthma, aged ≥12 years, and 309 physicians (104 allergists, 54 pulmonologists, 101 family practitioners, and 50 internists). Patients' asthma control perceptions (71% "completely controlled" or "well controlled") were inconsistent with their NAEPP control level as determined by self-reported symptoms (29% well controlled). Patients and physicians had low expectations for effective asthma management; patients considered asthma well managed if rescue medication was used three times per week (46%), urgent care visits occurred twice per year (67%), or emergency department visits occurred once per year (60%). Asthma-related syncope, seizure, intensive care unit admission, and intubation were associated with uncontrolled asthma based on NAEPP guidelines. Respiratory specialists (allergists/pulmonologists) implemented asthma management recommendations more than other physicians surveyed. However, only 22% of patients visited a specialist for usual asthma care and 48% had never visited a specialist. Despite detailed NAEPP guidance, asthma management and control in U.S. patients is unsatisfactory. Improved asthma control assessment (impairment and risk) and implementation of NAEPP management recommendations are needed to improve asthma control and outcomes.

Asthma burden in the United States: results of the 2009 Asthma Insight and Management survey.

Updated guidelines and new treatments for asthma have become available since the last major survey of asthma management in the United States was completed ∼11 years ago. The Asthma Insight and Management (AIM) survey was conducted to assess the current status of asthma burden in the United States. A geographically stratified screening of 60,682 households provided a national sample of 2500 patients with current asthma (2186 adults aged ≥18 years; 314 adolescents aged 12-17 years). A national sample of 1004 adults without current asthma was interviewed for comparison with the adult asthma population, and 309 asthma health care providers were surveyed for their opinions about the burden of asthma. Asthma prevalence in the United States was estimated at 8%. Twice as many adult asthma patients rated their health as "only fair," "poor," or "very poor," or experienced limitations in activity because of health problems, compared with the general population. Asthma also frequently caused negative emotional symptoms in patients. Most patients experienced asthma throughout the year (63%) and symptoms within the 4 weeks before the summer survey (68%). Overall, 41% of patients responded that asthma interfered with their/their child's life "some" or "a lot". During the year before the survey, 69% of patients experienced at least one severe asthma episode. Asthma burden in the United States remains high despite the availability of updated treatment guidelines and new therapies. Asthma care in the United States remains suboptimal, indicating the need for continued improvements in patient management.

Patient and physician asthma deterioration terminology: results from the 2009 Asthma Insight and Management survey.

Long-term achievement of asthma control is dependent in part on the use of mutually understandable asthma terminology in all verbal and written patient-physician communications. Using data from the Asthma Insight and Management (AIM) survey, the objective of this analysis is to provide a contemporary depiction of asthma deterioration terminology as used by current asthma patients and physicians in the United States. As part of the 2009 AIM survey, current asthma patients (≥12 years of age; weighted n = 2499) and physicians (n = 309) were queried about their recognition, understanding, and/or use of the terms "asthma attack," "asthma flare-up," and "asthma exacerbation" in telephone interviews. Nearly all patients had heard the term "asthma attack" (97%), but relatively few had heard the term "asthma exacerbation" (24%); 71% had heard "asthma flare-up." In contrast, physicians reported using the term "asthma attack" least (65%) and the term "asthma exacerbation" most (77%) when discussing asthma with their patients; 70% reported using "asthma flare-up." Among patients familiar with "asthma flare-up" and "asthma exacerbation" (n = 502), only 38% said that the terms mean the same thing; nearly all physicians (94%) said that the terms mean the same thing. Collectively, data from the AIM survey suggest that patients and physicians use different asthma deterioration terminology and, more importantly, that they do not necessarily understand each other's terms. Standardizing asthma deterioration terminology may help optimize asthma patient-physician communication to improve patient understanding of written asthma action plans and therefore, enhance patient outcomes.

Comparison of the Asthma in America and Asthma Insight and Management surveys: did asthma burden and care improve in the United States between 1998 and 2009?

Significant changes in asthma treatment guidelines and therapies occurred between the period of time in which the Asthma in America (AIA) and Asthma Insight and Management (AIM) surveys were conducted: 1998 and 2009, respectively. This study compares asthma burden and management in 1998 and 2009. Both surveys were telephone based and conducted across the United States. The AIA survey included 2509 patients with asthma (aged <1 year to 89 years old), 512 physicians, and 1000 adults from the general population. The AIM survey included 2500 patients (aged ≥12 years), 309 physicians, and 1090 adults from the general population. Patient responses were weighted to match the entire population of U.S. patients with asthma. The impact of asthma burden and care on the general population and on asthma patients was slightly lower or unchanged in the AIM survey versus the AIA survey. Acute care use (hospitalizations, emergency department visits, or other urgent care visits) was common in AIA (36%) and AIM (34%) surveys. Most physicians were aware of guidelines in AIA (90%) and AIM (96%), but fewer "always" followed them (AIA, 36%; AIM, 28%). Spirometry was often used to aid in diagnosis by asthma care specialists (AIA, 73%; AIM, 76%) but infrequently by nonsubspecialists (AIA, 27%; AIM, 38%). Most physicians prescribed inhaled corticosteroids (ICSs) for mild (AIA, 70%; AIM, 83%) or moderate (AIA, 89%; AIM, 83%) persistent asthma. In the AIM survey, 38% of specialists prescribed ICSs combined with a long-acting ß2-agonist for moderate asthma. The state of U.S. asthma care and clinical outcomes changed little from 1998 to 2009.

Burden of allergic rhinitis: allergies in America, Latin America, and Asia-Pacific adult surveys.

Allergic rhinitis (AR; also nasal allergies or "hay fever") is a chronic upper airway inflammatory disease that affects ∼60 million adults and children in the United States. The duration and severity of AR symptoms contribute to a substantial burden on patients' quality of life (QoL), sleep, work productivity, and activity. This study was designed to examine symptoms, QoL, productivity, comorbidities, disease management, and pharmacologic treatment of AR in United States and ex-U.S. sufferers. Allergies in America was a comprehensive telephone-based survey of 2500 adults with AR. These data are compared and contrasted with findings from the Pediatric Allergies in America, Allergies in Latin America, and Allergies in Asia-Pacific telephone surveys. The prevalence of physician-diagnosed AR was 14% in U.S. adults, 7% in Latin America adults, and 9% in Asia-Pacific adults. Nasal congestion is the most common and bothersome symptom for adults. Approximately two-thirds of adults rely on medication to relieve intolerable AR symptoms. Incomplete relief, slow onset, <24-hour relief, and reduced efficacy with sustained use were commonly reported with AR medications, including intranasal corticosteroids. One in seven U.S. adults reported achieving little to no relief with AR medications. Bothersome adverse effects of AR medications included drowsiness, a drying feeling, medication dripping down the throat, and bad taste. Perception of inadequate efficacy was the leading cause of medication discontinuation or change and contributed to treatment dissatisfaction. These findings support the assertion that AR burden has been substantially underestimated and identify several important challenges to successful management of AR.

Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD): Measurement Properties of Novel Patient-Reported Symptom Measures.

BACKGROUND: The Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) were developed to meet the need for standardized patient-reported measures of asthma symptoms to assess treatment trial outcomes in adults and adolescents. OBJECTIVE: To determine scoring and evaluate the measurement properties of the ADSD/ANSD. METHODS: Adolescents (12-17 years) and adults (18+ years) with asthma completed draft 8-item electronic versions of the ADSD/ANSD for 10 days alongside the Adult Asthma Symptom Daily Scales (AASDS) and a Patient Global Impression of Severity (PGIS). Using classical and modern psychometric methods, initial analyses evaluated the performance of ADSD/ANSD items to inform scoring. Subsequent analyses evaluated the reliability and validity of ADSD/ANSD scores. RESULTS: A demographically and clinically diverse sample (n = 130 adolescents; n = 89 adults) was recruited. Item performance was generally strong. However, items assessing chest pressure and mucus/phlegm demonstrated redundancy and poorer performance and were removed. Principal-components analysis, confirmatory factor analysis, and item response theory supported combining items to form 6-item total ADSD/ANSD scores. Internal consistency (α = 0.94-0.95) and test-retest reliability (intraclass correlation coefficient = 0.86-0.95) were strong. Strong correlations (r = 0.72-0.80) were observed between ADSD scores and AASDS items assessing asthma symptom frequency, bother, and impact on activities. Significant differences (P < .001) in mean ADSD/ANSD scores were observed between groups categorized by asthma severity (PGIS), asthma control, inhaler use, nebulizer use, activity limitations, and nighttime awakenings. CONCLUSIONS: The ADSD/ANSD items and scores demonstrated strong reliability and validity. Implementation of the measures in interventional studies will enable the evaluation of responsiveness and meaningful within-patient change.

Exercise-induced bronchospasm in children with asthma in the United States: results from the Exercise-Induced Bronchospasm Landmark Survey.

Despite the availability of effective therapies, uncontrolled asthma remains a common problem. Previous large surveys suggest that exercise-related respiratory symptoms may be a significant element of uncontrolled asthma. The Exercise-Induced Bronchospasm (EIB) Landmark Survey is the first comprehensive, national survey evaluating EIB awareness and impact among the general public, asthma patients, and health care providers. This study was designed to evaluate the prevalence and impact of exercise-related respiratory symptoms in children (aged 4-17 years) with asthma. A national survey was conducted with parents of 516 children diagnosed with asthma or taking medications for asthma in the prior year. The majority of parents reported that their child experienced one or more exercise-related respiratory symptom and almost one-half (47.4%) experienced four or more symptoms. Most commonly reported symptoms were coughing, shortness of breath, and wheezing. Respondents reported that asthma limited their child's ability to participate either "a lot" or "some" in sports (30%), other outdoor activities (26.3%), and normal physical exertion (20.9%). Only 23.1% of children with exercise-related respiratory symptoms were reported to take short-acting beta-agonists such as albuterol "always" or "most of the time" before exercising. Exercise-related respiratory symptoms among pediatric asthma patients are common and substantially limit the ability of children to participate normally and perform optimally in physical activities. Such symptoms may reflect uncontrolled underlying asthma that should be evaluated and treated with appropriate controller medications. Despite the availability of preventative therapy, many children do not use short-acting bronchodilators before exercise as recommended in national guidelines.

Impact of exercise-related respiratory symptoms in adults with asthma: Exercise-Induced Bronchospasm Landmark National Survey.

An estimated 5-20% of the general population and up to 90% of people with asthma experience exercise-induced bronchospasm (EIB). The EIB Landmark Survey is the first comprehensive study on exercise-related respiratory symptoms in the United States. Two surveys were conducted: the first surveyed adults (≥18 years) in the general public and the second surveyed adults with asthma or taking medications for asthma in the prior year. Parameters assessed included exercise-related respiratory symptoms, activity levels, and short-acting beta-antagonist (SABA) use. In the general public survey (n = 1085), 8% were currently diagnosed with asthma. However, 29% reported experiencing one or more of six respiratory-related symptoms during or immediately after exercising. In the EIB in adult asthma survey (n = 1001), although >80% of adults experienced one or more of six exercise-related respiratory symptoms, only 30.6% reported a diagnosis of EIB. Almost one-half (45.6%) of adults with asthma reported that they avoid physical activities because of symptoms. Despite symptoms, only 22.2% of respondents took SABAs before exercise "always" or "most of the time"; 36.3% took rescue medications after or during exercise. Exercise-related respiratory symptoms limit physical activities and negatively impact daily lives. However, adults in the United States lack awareness of EIB. Although many subjects stated that their asthma symptoms limit their physical activity, few adhered to treatment guidelines by using SABAs appropriately before exercising. Findings from this survey support the need for better communication about the proper evaluation and management of EIB in the community and in asthma patients.

Is there a role for aerosol nasal sprays in the treatment of allergic rhinitis: a white paper.

This White Paper presents the Consensus Statements derived from a Special Issues Board (SIB) held in Chicago, IL, in October 2010. The SIB was convened to address the question of whether there is a need for both aerosol and aqueous intranasal steroids (INSs) in the treatment of allergic rhinitis (AR). The faculty reviewed the published record of efficacy and safety of aerosol and aqueous INSs, as well as patient and physician satisfaction and preferences for currently available INSs, and burden of disease. Agreement on unmet needs also included the practice experience of the faculty and their colleagues. The body of evidence indicates that INSs are equally effective and well tolerated for most patients. However, differences exist among current aqueous formulations as well as between these products and their aerosol antecedents, based on the properties of the nasal spray. Aerosol formulations, although no longer available, may be preferred for some patients with specific pathophysiology and may be preferred by some patients based on sensory perception. There are good reasons to expand the currently available options of INSs by having both aerosol and aqueous formulations.

An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice.

BACKGROUND: The assessment of asthma control is pivotal to the evaluation of treatment response in individuals and in clinical trials. Previously, asthma control, severity, and exacerbations were defined and assessed in many different ways. PURPOSE: The Task Force was established to provide recommendations about standardization of outcomes relating to asthma control, severity, and exacerbations in clinical trials and clinical practice, for adults and children aged 6 years or older. METHODS: A narrative literature review was conducted to evaluate the measurement properties and strengths/weaknesses of outcome measures relevant to asthma control and exacerbations. The review focused on diary variables, physiologic measurements, composite scores, biomarkers, quality of life questionnaires, and indirect measures. RESULTS: The Task Force developed new definitions for asthma control, severity, and exacerbations, based on current treatment principles and clinical and research relevance. In view of current knowledge about the multiple domains of asthma and asthma control, no single outcome measure can adequately assess asthma control. Its assessment in clinical trials and in clinical practice should include components relevant to both of the goals of asthma treatment, namely achievement of best possible clinical control and reduction of future risk of adverse outcomes. Recommendations are provided for the assessment of asthma control in clinical trials and clinical practice, both at baseline and in the assessment of treatment response. CONCLUSIONS: The Task Force recommendations provide a basis for a multicomponent assessment of asthma by clinicians, researchers, and other relevant groups in the design, conduct, and evaluation of clinical trials, and in clinical practice.

Asthma management and prevention: current perspectives.

The continuing evolution of asthma treatment and prevention are reflected in updated guidelines from the National Asthma Education and Prevention Program and Global Initiative for Asthma as well as other recent publications. The 2007 Expert Panel Report 3 guidelines designate severity and control, mediated by considerations of current impairment and future risk, as the primary concepts in assessing and monitoring asthma. Severity should ideally be determined at the time of diagnosis, after which control becomes the central focus of asthma management. In the area of treatment, inhaled corticosteroids (ICSs) remain first-line therapy for longterm asthma management in children and adults. For patients whose severity of asthma requires more than low-dose ICSs, or whose asthma cannot be well controlled on monotherapy with low-dose ICSs, evidence supports the efficacy of combination therapy consisting of an ICS plus an inhaled long-acting beta2-agonist (LABA) or an increase to medium-dose ICSs. For children >5 years of age and adults not controlled on low-dose ICSs, the combination of a low-dose ICS plus an inhaled LABA is equivalent in terms of outcomes to the use of medium-dose ICS. For children <5 years of age not controlled on low-dose ICSs, increasing the dose of ICSs is preferred to the addition of a LABA to low-dose ICS therapy as no studies using combination therapy have been conducted for patients in this age group. With regard to asthma prevention, approaches to primary prevention (to avoid allergen sensitization) and secondary prevention (to avoid disease progression) are still very much in the developmental stage, while tertiary prevention (to avoid asthmatic stimuli) has been more successful particularly in pediatric patients. Written action plans as part of self-management processes appear to improve physician-patient communication and disease status tracking. Other considerations in successful asthma management include patient education and monitoring of adherence to treatment regimens.

Patient and physician perspectives on the attributes of nasal allergy medications.

Allergic rhinitis (AR) often requires regular prophylactic use of allergy medications for the effective long-term management of nasal symptoms. However, patient adherence to AR treatment is frequently poor. The Allergies in America survey of nasal allergy sufferers assessed 2500 adults diagnosed with AR. Four hundred healthcare professionals also participated in this survey. Participants were interviewed about their perceptions of the effectiveness and tolerability of AR medications and the relationship of these parameters to patient satisfaction with therapy. Only 15% of nasal allergy sufferers reported that their intranasal corticosteroid (INCS) provided complete symptom relief, and 48% of patients indicated that their INCS did not provide 24-hour symptom relief. Healthcare professionals agreed that intranasal corticosteroids do not provide complete 24-hour symptom relief. The most commonly reported adverse effects of all nasal allergy medications were a drying feeling (47%), dripping down the throat (41%), drowsiness (37%), bad taste (32%), burning (17%), and headaches (16%). Many patients indicated that these adverse effects were moderately or extremely bothersome. Thirty-two percent and 25% of patients, respectively, discontinued treatment because their nasal allergy medications did not provide 24-hour symptom relief or were associated with bothersome adverse effects. Patients and healthcare professionals do not believe that INCSs provide complete 24-hour symptom relief. In general, allergy medications also are perceived as conferring unpleasant adverse effects. Lack of efficacy and bothersome adverse effects contribute to lack of satisfaction with treatment and treatment discontinuation in patients with AR.

Intranasal corticosteroids in the treatment of allergic rhinitis.

Intranasal corticosteroids (INCSs) have been established as the first-line treatment of moderate to severe allergic rhinitis (AR). Compared with other monotherapies, INCSs are most effective at controlling underlying allergic inflammation and providing symptom relief. Although currently available INCSs show comparable efficacy in controlling nasal symptoms of AR, onset and duration of action are thought to be somewhat variable among the INCSs. The low frequency of side effects suggests that, at recommended doses, INCSs are safe for the treatment of AR. However, concerns remain regarding the long-term systemic side effects associated with INCS therapy. Recent clinical studies have indicated that ciclesonide provides effective relief from nasal symptoms of AR and may have a rapid onset of action. Moreover, the results of two clinical trials, including a 52-week study, have suggested that intranasal ciclesonide does not cause cortisol suppression. Furthermore, intranasal ciclesonide does not have an additive effect on the hypothalamic-pituitary-adrenal-axis function when administered in combination with inhaled corticosteroids (ICSs), indicating that intranasal ciclesonide can be used in combination with an ICS in patients with asthma and comorbid AR. Therefore, intranasal ciclesonide appears to provide an additional treatment option for patients with AR.

Management of chronic obstructive pulmonary disease associated with chronic bronchitis with inhaled fluticasone propionate/salmeterol (ADVAIR DISKUS) 250/50: results of a patient experience trial.

CONTEXT: Chronic obstructive pulmonary disease (COPD) is recognized as a major healthcare problem in the United States and around the world. OBJECTIVE: This survey regarding initial experience in patients with COPD collected feedback about newly initiated therapy with fluticasone propionate/salmeterol (FSC; ADVAIR DISKUS). DESIGN: 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. SETTING: One thousand primary care physicians recruited outpatients into the trial. PATIENTS: Patients were either newly diagnosed with COPD associated with chronic bronchitis or were still experiencing breathing difficulties on an anticholinergic medication. INTERVENTIONS: Patients initiated FSC 250/50 and received a 1-month supply of FSC 250/50 with an albuterol inhaler for rescue use. MAIN OUTCOME MEASURES: Outcome measures were patient perceptions of satisfaction, compliance, and convenience and changes in breathing on 1 (negative) to 9 (positive) point scales. RESULTS: 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). CONCLUSION: 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.

Combination therapy with inhaled long-acting beta2-agonists and inhaled corticosteroids: a paradigm shift in asthma management.

Long-acting inhaled beta2-agonists and inhaled corticosteroids are classes of drugs with different mechanisms of action that are commonly used to provide effective long-term control of persistent asthma. Scientific and clinical data support the complementary mechanisms of action of the inhaled corticosteroids and the long-acting beta2-agonists in achieving a superior level of asthma control. In addition, evidence supports significant reductions in exacerbations and effective control of airway inflammation with an inhaled corticosteroid and a long-acting beta2-agonist versus higher dosages of inhaled corticosteroids or combinations of other therapeutic agents with an inhaled corticosteroid. Finally, there are distinct economic advantages to combining an inhaled corticosteroid and a long-acting beta2-agonist in the treatment of asthma relative to other treatment regimens.