View clinical trials related to Asthma.
Filter by:Background: Asthma is a common chronic condition characterized by respiratory symptoms and hyperresponsive airways. According to treatment guidelines, patients with persistent asthma require daily treatment with inhaled corticosteroids (ICS). However, certain subgroups of asthma patients such as non-eosinophilic asthma patients do not respond well to the ICS treatment. In the present study, asthma patients treated with ICS and exhibiting low levels of eosinophilic biomarkers such as S-periostin, FeNO and blood eosinophils, are randomized 1:1 to either 1) tapering of ICS or 2) usual care. Thus, the aim of the present study is to investigate whether patients with non-eosinophilic asthma can sustain their level of disease control during ICS tapering. Design: This is a randomized, controlled, one-center, non-inferiority study of ICS tapering in patients with non-eosinophilic asthma. Inclusion and exclusion criteria: 1) Objectively secured asthma diagnosis, 2) Age 18-65 years, 3) ICS treatment equivalent to Budesonide 800 microg daily or more with at least 80% adherence, 4) Serum-periostin < 50 ng/ml, 5) FeNO<25 ppb at all prior visits, 6) Blood-eosinophils<0.15 at screening, 7) no allergic asthma history, 8) no daily smoking within 6 months, 9) no other respiratory disease, 10) no daily treatment with immunosuppressives, 11) no pregnancy, and 12) no history of drug or alcohol abuse. Endpoints: Primary: Change in Control Questionnaire (ACQ) from baseline to post-tapered ICS and time from baseline to drop-out. Secondary: Change in FeNO, change in Serum-Periostin, change in FEV1, change in blood-eosinophils. Methods: Relevant patients will be recruited from Respiratory Outpatient Wards. In total, 110 patients will be required. Visits will be performed at screening, at week 0, 4, 8, 12, 16, 26, 52. In the active arm, ICS dosage will be reduced to 50% at week 0 and removed at week 8. All visits include ACQ, FeNO, spirometry, blood eosinophils. S-periostin will be measured at screening and at week 8 and 16.
In this integrated, multi-part, Phase I study, the safety, tolerability, food effect, pharmacokinetic (PK) and pharmacodynamic (PD) properties of single and repeated doses of AZD9898 will be investigated.
This is a non-confirmatory, randomized, subject and investigator blinded, placebo-controlled, parallel-design, multi-center bronchoprovocation study. Approximately 55 subjects with mild stable atopic asthma who exhibit an EAR and LAR to a common inhaled allergen will receive multiple once daily doses of inhaled CSJ117 or placebo over 12 weeks. Two sequential dose cohorts are planned for this study, Cohort 1 and Cohort 2. Cohort 2 will be split into two parts, Cohort 2a and 2b
The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients
The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic Error in COPD and Asthma patients.
A Phase 1 investigation will be performed to test the safety of two doses of bone marrow-derived MSCs (20,000,000 and 100,000,000) administered via peripheral intravenous infusion.
Asthma is a chronic disease. Prevalence of asthma in 2014 among Spanish population was 5%, of which 10% were diagnosed with severe asthma. According to Spanish National Guideline for the Management of Asthma (GEMA) 4.1 criteria, asthma can be classified according to its severity (intermittent, mild persistent, moderate persistent or severe persistent) or level of asthma control (controlled, partly controlled or uncontrolled). This Guideline describes that only 1 in 10 subjects with severe asthma is well controlled, meaning that there is a 90% prevalence of non-controlled severe asthma. This prospective, non-interventional, observational, multicenter and case-control study aims to assess the prevalence of severe asthma in Spanish Hospitals. The study will describe the characteristics of severe versus non-severe asthmatic subjects, assess their eligibility to receive biological treatments approved for this disease, resource consumption and evaluate the most prevalent phenotypes of severe asthma in Spain. Enrolled subjects will be divided into two cohorts, based on asthma severity according to the Global Initiative for Asthma (GINA) and the International European Respiratory Society (ERS)/American Thoracic Society (ATS) Guidelines. Cohort A: subjects diagnosed of severe asthma and Cohort B: subjects with non-severe asthma. Approximately 320 severe asthmatic subjects and 160 non-severe asthmatic subjects will be enrolled in the study. A software of big data will be used to do a sub study for comparing the results obtained through this software tool against results obtained through Gold standard classical methods used in this prospective observational study (the descriptive assessment of severe asthma prevalence and the prospective evolution of subjects).
This study evaluated whether physiotherapy is efficient in sputum induction and in evaluation of pulmonary inflammation in asthmatic children.
The primary objective of this study is to investigate safety and tolerability of three consecutive administrations, 12 hours apart, at three different dose-levels of BI 443651 administered via oral inhalation in male and female mild asthmatic subjects after a bolus methacholine challenge.
This study aims to first determine whether high child stress leads to reduced response to common treatmenIs for asthma (inhaled corticosteroids and short-acting bronchodilators), and then to identify DNA methylation differences leading to stress-induced treatment resistance among children with asthma.