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In this 7-month randomized controlled trial, children aged 1 to less than 6 years, with recurrent asthma attacks triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5 months during their usual clinic visit, and a daily supplement of vitamin D or a placebo. This study will test whether children in vitamin D group have less frequent and less severe asthma exacerbations compared with those receiving placebo.The study will also document the safety profile of this strategy.
This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.
The objective of this study is to evaluate fluticasone furoate/vilanterol compared with fluticasone furoate alone in subjects with asthma that is uncontrolled on low to mid dose inhaled corticosteroid (ICS) or low dose ICS/ long acting beta agonist (LABA) combination. This is a phase IV, randomized, double-blind, parallel group, multicenter study evaluating fluticasone furoate/vilanterol 100/25 micrograms (mcg) and fluticasone furoate 100 mcg once daily, delivered as an inhalation powder using the ELLIPTA® device in subjects with uncontrolled asthma despite daily ICS or ICS/LABA therapy. The study will measure treatment response and asthma control using the Asthma Control Questionnaire-7 (ACQ-7) focusing on symptomatic control. In this study, proportion of subjects with an improvement in ACQ-7 score of >=0.5 at Week 12 compared to Baseline for the fluticasone furoate/vilanterol 100 mcg/25 mcg and fluticasone furoate100 mcg groups will be assessed. The total study duration for each subject will be 17 weeks including 4-week run in period, 12-week treatment period and 1-week follow up period. Approximately 1012 subjects will be randomized into the study. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.
Eosinophil infiltration and degranulation in airways has been implicated in the pathology of asthma. Periostin is considered to be a marker of eosinophilic inflammation and is one of the highly expressed genes in epithelial cells and lung fibroblasts in asthma. Omalizumab is approved as add-on therapy in the treatment of severe allergic asthma. The aim of the study is to assess inflammatory biomarkers including: blood and sputum eosinophilia, periostin and IL-6 as long-term clinical outcomes of omalizumab therapy.
Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma
This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness. It will also evaluate whether this device can detect when a person's breathing problem is getting worse.
Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs which is generally caused by smoking tobacco. It is a largely preventable disease that causes severe and irreversible damage to the lungs. If not detected early, this damage will progress causing significant breathing difficulties, disability and poor survival rates. Patients with COPD can experience exacerbations of their disease which can also lead to can be described as a worsening of the patients symptoms COPD is a global health concern and it is estimated to become the third leading cause of death by 2020. In the United Kingdom, around 900,000 people have a formal diagnosis of COPD. However, it is believed that over 2 million more people may be living with the disease and are unaware that they have it. The cost of treating lung disease in the National Health Service (NHS) is estimated to be approximately £4.7billion per year . The majority of these costs are caused by a small group of COPD patients with severe disease and complex problems , . Late diagnosis has been proven as a contributing factor to the worsening of COPD, disease progression and increased healthcare costs. Indeed, recent research has shown that patients may attend their general practitioner (GP) practice with signs of the disease up to five years before they have the condition diagnosed. A delay in diagnosis is known to hasten the decline in lung function and worsen disease severity making treatment options less useful in the long term. This has led to national guidelines recognising that patients with COPD need to be diagnosed and treated effectively at the earliest opportunity. The aim of this study is to find the best way to identify or 'case find' patients who have not yet been diagnosed with COPD, and also identify patients with more complex disease using a computerised search programme. The study will examine whether this intervention has saved the NHS money by reducing GP and hospital visits and by decreasing rescue medicine usage for respiratory problems, by comparing this data to similar GP practices where the intervention had not been implemented. Once patients have been identified, they will be invited to attend a clinic appointment at their GP practice to participate in a tailored intervention programme for patients at risk of having COPD and those with existing complex COPD. GP practices will also be offered a training package in order to continue the intervention programme in the future.
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma
Asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory conditions involving the small airways with airflow limitations resulting from genetic and environmental interactions. Currently, there are no existing subject diaries with evidence of responsiveness to measure the daily symptoms of asthma. Therefore, there is a need to either develop a new symptom diary to characterize subject burden of asthma symptoms or modify/adapt an existing tool from a related disease area for use in subjects with moderate to severe asthma. The E-RS in COPD (E-RS: COPD®) questionnaire was developed as a measure of daily respiratory symptoms associated with COPD. The fixed dose combination of fluticasone furoate/ umeclidinium/ vilanterol (FF/UMEC/VI) administered via the ELLIPTA® dry powder inhaler (DPI) has been developed for the treatment of asthma. This cross-sectional, qualitative study is designed to understand the symptoms and disease experience of subjects with moderate to severe asthma. This study will also evaluate underlying concepts that are most important to asthmatic subjects compared to symptoms and concepts included in the E-RS: COPD and two supplemental asthma items (wheeze and shortness of breath with physical activity). Approximately 32 subjects will be included in the study and interviewed via telephone. Each interview including time for consent, qualitative interview, and completion of case report forms (CRFs) is expected to last approximately 60 to 90 minutes. Subjects will be expected to complete a daily diary for the next 7 days, following the initial telephone interview. E-RS: COPD and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.
We are going to start a randomized double blind placebo control study. One hundred severe asthmatic patients will receive "Probiotical ®" each day during 3 months and will be evaluated before and 1-3-6 months after in order to assess the impact of the synbiotic on the lung function, the exhaled nitric oxide value, the inflammatory blood and sputum profiles, the bronchial reactivity, the microvascular health and the quality of life and asthma control. The hypothesis is that, as these patients are not optimally controlled, the synbiotic could have an impact by decreasing the inflammation state at local and systemic level and then improve the quality of life and the asthma control. Indeed, synbiotic have been shown to possess beneficial effects on the immune system.