Written Asthma Actions Plans Versus No Written Instructions In Specialty Care
AsthmaThe overall goal of this randomized, controlled study is to compare a model written treatment plan with the usual care that is provided by a group of adult and pediatric pulmonologists and allergists in their practice settings. The written treatment plan is a form that allows a treatment regimen that is consistent with National Heart, Lung, and Blood Institute (NHLBI) guidelines to be conveyed to patients. Barriers to the use of written plans will be identified to better understand why some patients and physicians use written treatment plans more frequently and effectively than others. An additional goal is to assess how patients from different racial/ethnic backgrounds utilize treatments plans. Because asthma disproportionately affects African American and Latino patients, another goal of this study is to better understand if there are fundamental differences in the way patients from racial/ethnic minority groups self-manage asthma in comparison to their white counterparts. The study will also try to determine if differences exist in the way physicians care for minority patients. If there are differences, it is important to determine if the disparities can be overcome with the use of a written treatment plan form.
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants...
Exercise Induced AsthmaThe purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.
A Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent...
AsthmaThe purpose of this study is to determine the safety and effectiveness of tacrolimus inhalation aerosol in subjects with persistent asthma.
An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study...
AsthmaThis is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects in the New Treatment Group may require additional visits for study drug injections (as frequently as every 2 weeks). Data collection during these additional visits will be limited to the assessment of adverse events. The study will evaluate all serious and nonserious adverse events, laboratory assessments, data on asthma exacerbations, and concomitant medication usage.
Asthma Patient Education in the Emergency Room
AsthmaThe objective of this randomized trial is to assess the effectiveness of an intervention involving education, self-efficacy, and social support in improving quality of life outcomes among 296 adult asthma patients treated in the emergency room. The main outcome will be a comparison of within-patient change in quality of life between enrollment and 8 weeks. Secondary objectives will be to assess the effectiveness of the intervention in decreasing the need for rescue inhaled beta agonists, in improving peak flow meter rates, and in decreasing the number of days lost from work or school due to asthma. These outcomes will be measured again at 16 weeks to determine if benefits are sustained. Additional outcomes at 16 weeks and 1 year will be to assess the effectiveness of the intervention in decreasing urgent resource utilization for asthma and cost effectiveness.
Childhood Asthma Management Program (CAMP) Phases I (Trial), II (CAMPCS), III (CAMPCS/2), and IV...
AsthmaLung DiseasesThe purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma...
AsthmaThis is a Phase IIa, randomized, placebo-controlled, double-blind, multicenter, two-arm study to evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A as an add-on therapy in patients with uncontrolled moderate to severe asthma who are receiving daily ICS therapy and at least one of the following additional controller medications: long-acting beta-agonist (LABA), leukotriene modulator (leukotriene modifier [LTM] or leukotriene receptor antagonist [LTRA]), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation.
Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe...
AsthmaStudy D9181C00001 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of MEDI3506 in adult participants with uncontrolled moderate to severe asthma on standard of care (SOC). Up to approximately 80 sites globally will participate in this study. Approximately 228 participants will be randomized to 3 treatment groups in a 1:1:1 ratio to receive MEDI3506 dose 1, MEDI3506 dose 2, or placebo.
Study to Assess the Safety and Efficacy of SelK2 on Airway Responses Following Allergen Challenge...
AsthmaChronic Obstructive Pulmonary DiseaseThis study has two parts. The main purpose of Part 1 of this study will be to examine how safe and effective two doses of SelK2 is on participants with mild asthma. Lung function and inflammatory cell numbers will be measured in response to the administration of an allergen (a compound to which the participant is allergic) into the lungs in the presence or absence of SelK2. Part 2 of this study will examine how safe and effective one dose of SelK2 is on participants with chronic obstructive pulmonary disease (COPD). Lung function and inflammatory cell numbers will be measured in COPD patients in the presence or absence of SelK2. SelK2 may block the movement of key inflammatory cells into the lungs and consequently improve lung function in these two patient populations.
Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants...
Moderate to Severe AsthmaThis is a Phase 3b, multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of tezepelumab (210 mg subcutaneous [SC] every 4 weeks [Q4W]) on antibody responses following seasonal quadrivalent influenza virus vaccination in the fall/winter 2021-2022 in the USA.