View clinical trials related to Asthma.
Filter by:The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when administered by inhalation in adult asthma patients
The primary objective was: - to assess the bioequivalence of a single dose (two inhalations) of the test product compared to the reference product, with and without charcoal blockade. The secondary objectives were: - to assess the pharmacokinetic profile of budesonide and formoterol in plasma after a single dose (two inhalations) of the test product and the reference product, with and without charcoal blockade. - to assess the safety and tolerability of the test product and the reference product, with and without charcoal blockade.
The purpose of this study is to obtain markers of airway inflammation from the exhaled breath condensate (the moisture in exhaled air) for comparison to blood based markers. These markers will be compared in tetraplegic, asthmatic and able-bodied control groups. Additionally, lung function testing will be performed, and the associations between breath condensate and blood markers and pulmonary function explored between groups.
This Phase IV study is an a multi-centre, randomised open label, two way cross-over design to evaluate the efficacy, safety, and tolerability of NEUMOTEROL 400 in subjects with asthma. The study will be used to demonstrate the non-inferiority of Budesonide/Formoterol Fumarate combination (BFF) 400/12 micrograms (mcg) single capsule inhaler (NEUMOTEROL 400) compared with BFF 320/9 mcg SYMBICORT Forte TURBUHALER® inhaler. The population for this study will be adult subjects (>=18 and <=80 years) with a diagnosis of asthma who have a pre-bronchodilator forced expiratory volume in one second (FEV1) of 40% to 85% of the predicted normal value, and are receiving a stable dose of inhaled corticosteroid inhaled corticosteroid (ICS) with or without long-acting beta-adrenergic agonist (LABA) prior to screening. The study will consist of six phases: Prescreening, Screening/Run-in (4 weeks), Treatment Period 1 (4 weeks), Washout (minimum 4 weeks), Treatment Period 2 (4 weeks) and Follow-up (1 week). The total duration of the study for each subject will be at least 17 weeks. There will be up to 6 study visits and a follow-up telephone call. Pre-screening Visit will allow subjects who had recent asthma medication changes to be stabilized prior to Screening. During the run-in and wash-out periods, all the subjects will receive budesonide dry powder inhaler (DPI) 400 mcg twice daily (BID) (NEUMOTEX™ 400) and salbutamol 100mcg pressurized metered dose inhaler (pMDI) on demand, as rescue medication. The dose of NEUMOTEROL 400 (400/12 mcg) and SYMBICORT Forte (320/9 mcg) will be one inhalation BID, and each treatment will be given to all subjects for 4 weeks (with a 4-week Washout Period between treatments). The study will include 300 subjects for screening so that at least 210 will be randomised and a minimum of 168 subjects complete the study/are evaluable. Half the subjects will be on Regimen A in Treatment Period 1and will then be crossed over to Regimen B in Treatment Period 2, and vice versa. Regimen A: BFF (400/12 mcg) by single capsule inhaler. Regimen B: BFF (320/9 mcg) TURBUHALER inhaler. The treatment periods will be separated by a washout Period of 4 weeks. NEUMOTEROL and NEUMOTEX are trademarks of the GSK group of companies SYMBICORT and TURBUHALER are trademarks of AstraZeneca
This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.
Is Yogic Exercises (12 weeks) increasing respiratory function, functional capacity and quality of life in patients with obstructive lung diseases. With follow up after 6 months.
In response to Program Announcement (PA)-09-164, "NIH Exploratory/Developmental Research Grant Program (R21) a randomized pilot study testing the efficacy of SWIFT: Social Work Intervention Focused on Transitions among at-risk older adults following hospital discharge to home. This study is drawn from several observations. First, transitions between care settings create elevated risk for poor outcomes and for readmission among older adults leaving the hospital for home largely due to fragmented care and poor communication. Next, while few studies exist that test methods to improve transitions, those available are largely medically focused, using a nurse or advanced practice nurse in their approach. Although evidence exists to support the effectiveness of these models, few have been replicated and none have been integrated into standard health care practice. This may be attributed to several factors including the availability of the needed staff, the lack of existing structures to support these roles, and the costs of implementing these interventions. Finally, a social work driven intervention may provide a replicable mechanism for bridging medical care, addressing psychosocial needs as well as medical needs, and improving linkages with community services while reducing care duplication. This study aimed to test a structured social work transition intervention model to reduce rates of hospital readmission and medical service use while improving patient satisfaction with the care transition process. A randomized pilot study was used to test a social work transitions model designed to improve care provided to frail older adults being discharged from the hospital to return to the community. Eligible patients consenting to participate (n=181) were randomly assigned to either the social work transitions model intervention or usual care. This project was conducted at Huntington Hospital, a 525-bed, nonprofit, community hospital located in Pasadena, California. In an average year, Huntington Hospital has approximately 10,000 older adults discharged from their facility, 44% of who are 80 years old or older. Those randomized to the intervention arm received up to six sessions from the social worker, at least one provided in the home. The social work intervention was designed to overcome common problems following hospital discharge including medication review, discussion and planning around discharge instruction, assistance in scheduling follow up appointments, assessments of psychosocial and other support service needs and provision of linkages to address those needs. Outcomes were measured three and six months following arrival at home, with an interim measure of satisfaction at 10 days following arrival at home, with measures including patient level of depression, pain, physical functioning, self-efficacy with disease management, and medical service use.
Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against stimuli that produce bronchoconstriction. The combination of long-acting beta agonists (LABA) and inhaled corticosteroids (ICS) has become the most commonly used asthma controller medication class in the United States, but unfortunately, even when LABAs are added to ICS and used regularly, 58-81% of patients with asthma fail to achieve total control. Regular use of beta-agonists, both short and long-acting, reduces the ability of these agents to protect against the airway narrowing that occurs in asthma in response to bronchoconstrictor stimuli. We refer to this reduced effect as loss of bronchoprotection. In this proof of concept trial we aim to determine if alendronate, which diminishes beta-2 adrenergic receptor internalization, can reduce the loss of bronchoprotection that occurs with regular use of LABAs, even when used in combination with ICS.
This protocol describes a single site mechanistic study to investigate microRNAs (miRNAs) that are differentially expressed in the airway epithelium of patients with asthma at baseline and in response to allergen challenge. We hypothesize that allergen exposure enhances airway smooth muscle contractility and epithelial cell mRNA/miRNA production as a consequence of locally increased T-cell derived cytokine production. The study will involve three visits over the course of approximately 14 days. At Visit 1, participants will be characterized in detail with lung function testing, methacholine challenge testing, and allergen skin prick testing. At Visit 2, participants will undergo bronchoscopy with segmental allergen administration of either cat or dust mite standardized allergen extract. At Visit 3 (either 24 hours later or 7 days later), bronchoscopy will be performed to collect airway samples including bronchoalveolar lavage (BAL), epithelial brushings and endobronchial biopsies. Sample analysis will include measurement of miRNA and mRNA expression in epithelial brushings (RNAseq and qPCR); analysis of cell surface markers on BAL cells and blood cells; and collection of endobronchial biopsies for immunostaining of immune cells localization, immunoblotting of smooth cell protein phosphorylation, analysis of mucin content and smooth muscle cell subculture. A total of 38 subjects (26 asthmatics with stable or well-controlled asthma, 6 allergic non-asthmatics and 6 non-allergic non-asthmatics) will complete the study.
Background: Asthma is the most common chronic disease of childhood with a prevalence that is 1.6 times greater in African American children than in Non-Hispanic White children.1 Nationally, 700,000 children are seen for asthma in Emergency Departments every year, 1% of which are seen at Children's National Health System in Washington, District of Columbia. School performance and school attendance has not been well studied in urban children with asthma, especially at the middle school level. Objective: Our purpose is to test the hypothesis that middle school children with asthma have worse school performance than middle school children without asthma in Washington DC and Prince George's county schools. Methods: The investigators will conduct a cross-sectional observational study of middle-school (grades 6-8 in the 2013-2014 school year) aged children with and without asthma recruited from the Emergency Departments and the IMPACT DC asthma clinic at CN. The investigators will collect demographic information, asthma severity information (for cases), and request that parents mail report cards and standardized test scores directly to the investigators. The investigators will use multivariable linear and logistic regression to determine if the presence of asthma is associated with school performance.