View clinical trials related to Asthma.
Filter by:Asthma and chronic obstructive pulmonary disease (COPD) are common lung. Despite the important progresses achieved in treatments, the majority of affected patients suffer from severe symptoms and tend to be frequently hospitalised due to exacerbation. Reasons for uncontrolled asthma and COPD are manifold, but often a poor inhalation technique and a poor following of the prescribed treatment plan is observed, which is called non-adherence. The primary aim of this study will therefore be to measure medication adherence in patients with chronic obstructive lung diseases, and to investigate the impact of an audio reminder on disease outcomes and quality of life. The investigators hypotheses will be that an adherence reminder, improve medication adherence and that a good medication adherence elongate the time to next exacerbation in patients with chronic obstructive lung diseases. A prospective single-blind randomized controlled study is planned, where the investigators are going to analyse the adherence over a period of six months of in- and outpatients, who have experienced at least one exacerbation during the last year. The adherence of intervention- and control group will be measured by specific electronic data capture devices which can save each actuation with date and time. Patients assigned to the intervention group will be reminded for the inhalation by an audio reminder and will receive support calls if medication will not be taken as prescribed or if rescue medication will be used too often. In contrast, the control group, will not be reminded and will not receive any calls, if do not comply with the prescribed medication schedule or if they use their rescue medication too frequently. During study period, participants will be assessed every two months. Each assessment will include spirometry, measurement of diffusion capacity, exhaled nitric oxide and carbon monoxide. Moreover participants will demonstrate their inhalation techniques by using placebo devices and fill out questionnaires regarding quality of life. Statistical significance will be acquired if a p value of less than 0.05 is attained. Time to next exacerbation will be compared using the Kaplan-Meier method and Cox proportional hazard model. Results will be reported as HR (hazard ratio) with corresponding 95% confidence interval (CI) and p-value. "Time to next exacerbation" is subject to the investigators power calculation. A previous study has shown that 30% of COPD patients are readmitted again within six month because of an exacerbation. The investigators expect that 12% of patients in the intervention group will have an exacerbation. This corresponds to a hazard ratio of 0.36. Assuming a sample size of 70 subjects for each study group, there is a power of 80% to detect a HR of 0.36 based on a one-tailed test. Additional 14 subjects (7 for each study group) have been added to account for drop outs. Therefore, 154 subjects will be investigated in this study.
Asthma is one of the main chronic diseases in childhood and it is characterized by the inflammation of airways. Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance due to pulmonary limitations. The pulmonary rehabilitation may improve the physical capacity in asthmatic patients, as observed in other chronic lung diseases.
Depression and other unhealthy behaviors, such as not taking medication as prescribed and not attending doctor visits have been suggested to increase the worsening of allergic diseases (e.g. asthma, urticaria). We intend to determine whether a one-session behavioral intervention is effective in helping with depression and controlling disease symptoms. We will measure this using pre- and post-intervention surveys.
This multiple ascending dose study is to determine the safety and bronchodilator activity of TRN-157 in 59 mild and moderate asthmatics.
"Studio Nava" is a National Study aiming to assess allergic rhinitis and asthma outcomes on Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. "Studio Nava" also proposes the innovative use of a web platform ("http://nava.ibim.cnr.it/") that contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI, Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents; Rhinasthma; VAS scale), that will be available for the doctors after the registration to the web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to fill them during the waiting time of the visit.
Mepolizumab is a humanized immunoglobulin G (IgG1) monoclonal antibody (mAb) that exhibits dose proportional and time-independent pharmacokinetics. The study will be conducted in 2 parts. Part A: it will be pharmacokinetic (PK) and pharmacodynamic (PD) study conducted to support the use of mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma and characterize the PK/PD of mepolizumab 40 milligrams (mg) or 100 mg administered subcutaneously depending on participant body weight. Part B: It is a long-term safety / pharmacodynamic phase in which extended treatment for a further 52 weeks will be offered on an optional basis to those subjects eligible for continued treatment. Participants with bodyweight <40 kilogram (kg) will be dosed with mepolizumab 40 mg and participants with body weight >=40 kg will be dosed with mepolizumab 100 mg subcutaneously in upper arm or thigh at Visit 2 (Week 0). Approximately 40 male or female participants aged 6 to 11 years will be screened to achieve approximately 28 eligible participants entering the treatment phase to allow availability of 20 evaluable participants, with a minimum of six participants enrolled in the <40 kg bodyweight group. The total duration of the study will be 22 weeks and will include a run-in period of 1-2 weeks, a treatment period of 12 weeks and a follow-up phase of 8 weeks. A participant will be considered having completed the study if the participant completes all phases of the study including the follow-up phase (Week 20 [visit 8]).
Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children. A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes. Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.
Asthma in the elderly is poorly understood, as most studies have not included this patient group. In a previous study of adults with asthma, choline supplementation had a positive effect on asthma symptoms and allowed to decrease asthma pharmacologic treatment. The present study is a randomized, double-blind, placebo-controlled, cross-over study of choline supplementation. The investigators will study the effect of choline 650 mg taken orally twice daily x 6 weeks versus placebo on asthma symptom scores (Asthma Control Test) and spirometric values (FEV1, FEV1/FVC, FEF25-75%). The investigators will also look at the effect of choline supplementation on peripheral blood eosinophils, serum immunoglobulin E (IgE) and homocysteine levels.
The aim of the study is proof of concept and to establish the feasibility of performing a study of resistive flexibility and strength training (RFST) in patients with asthma, with the future goal of designing a larger randomized trial to test the hypothesis that RFST leads to greater improvement in asthma symptoms, pulmonary function tests, range of motion and connective tissue mobility compared with a control conventional physical therapy intervention.
This Phase 2 protocol is designed to compare two dose levels of Vapendavir versus placebo. The objectives are to obtain safety and efficacy data in moderate to severe asthmatic patients, aged 18 to 75 years at risk of loss of asthma control due to presumptive Human Rhinovirus infection.