A Phase IIA FF/VI Study to Measure FeNO in Asthmatic Patients.
AsthmaFor asthmatic subjects, a combination of inhaled corticosteroid (FF) and long-acting beta2 receptor agonist (VI) is recommended for use (once daily) and fraction of exhaled nitric oxide (FeNO) is a non-invasive airway inflammation marker. In this randomised, double blind, placebo-controlled, two-period, crossover repeat dose study, the duration of action of fluticasone furoate (FF) will be determined by monitoring the return of FeNO levels to baseline, following the treatment with FF/vilanetrol (VI) in asthmatic subjects. Subjects who meet the eligibility criteria will participate in the following two treatment periods: FF/VI 100/25 mcg once-daily and placebo once-daily. Approximately 28 subjects will be enrolled in order to achieve 24 evaluable subjects. A 2-week treatment period will be followed by a 21-day monitoring/washout period before crossing over to the next treatment period. Total duration of each subject will be a maximum of 21 weeks. FeNO will be monitored up to 21 days after treatment with FF/VI together with FEV1 (up to 7 days).
Effects of an Exercise Program for Children With Asthma
Asthmaexercise program in the pulmonary function and cardiorespiratory fitness in children with asthma and respiratory symptoms
Beta Blocker Therapy in Mild to Moderate Asthmatics
AsthmaCurrent asthma medicines include inhalers. A common type of inhaler is called a 'beta-agonist' (e.g. salbutamol). They improve asthma symptoms by stimulating areas in the airway causing it to widen. Although these drugs are useful short term, long term use can make asthma worse in some people. 'Beta-blockers' are the complete opposite type of medication. Just now they are avoided in patients with asthma. Beta-blockers cause problems in asthmatics in the short term, including severe asthma attacks. The other mainstay of inhaler treatment for asthma is inhaled steroid or 'preventer' medication. These work by dampening down the inflammation in the lungs that occurs in asthma. New research has suggested that longer term use of beta-blockers can also reduce airway inflammation which may improve asthma control. This research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. At the moment the investigators are studying to see if there is a benefit of beta-blocker use for asthma over and above asthmatics own usual doses of inhaled steroids. In this study, the investigators will be trying to find out if adding a beta blocker to a smaller dose of steroid inhaler has the same effect on asthma control as just using a higher dose of steroid inhaler by itself.
Relief of Acute Bronchoconstriction/Asthma Using the Non-Invasive AlphaCore Device
AsthmaThe purpose of this pilot study is to collect preliminary clinical data related to the safety and preliminary clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore™ device for the relief of acute bronchoconstriction due to asthma. Up to 30 subjects who meet all inclusion/exclusion criteria and consent to participate in the study may be enrolled at up to 5 investigational (study) sites. The study sites are clinic settings capable of treating any potential complications of bronchoconstriction, an acute exacerbation of asthma, and any emergencies associated with use of the investigational device.
Management of Asthma in School-age Children on Therapy
AsthmaAsthma affects 1 in 8 children in the UK. Up to half of these are treated with preventative medicine in the form of low-dose steroids using an inhaler. The National Asthma Treatment Guidelines recommend when this treatment is not working other treatments are started. Studies to support this have taken place in adults but not with children. If patients are instructed how to use inhalers and are given information about asthma, they can control their disease much better. The first part of this study, lasting 4 weeks, will make sure the children and their families understand how to use their inhaler. All children will be given the same steroid inhaler to use and after 4 weeks those still with symptoms will enter the study proper which lasts for 48 weeks. During this part of the study the children will be given one of three treatments. These are:- a steroid inhaler + a dummy tablet, an inhaler containing a steroid and a long-acting reliever + a dummy tablet or a steroid inhaler + an active tablet. In this way the patient, the family and the researchers will not know which of the three treatments the child is taking until the code is broken at the end of the study. What matters to children is how they feel, are they able to run around and play with friends and are they well enough to go to school. The investigators will assess which of the above treatments best allow these to happen by asking the parents and children to fill in questionnaires on 4 occasions during the study. The investigators will also see which treatment best prevents the need for short courses of steroids tablets during the study. These are commonly given when asthma symptoms worsen. Most children will be started in the study through their general practitioner clinic. It will take one year to enroll all 900 children. Once enrolled the children will be followed-up in hospital centres. Much of the funding will be required to recruit and follow-up the children, train everyone to the same standard and develop and administer the questionnaires and health economic assessments. Asthma care is an expensive. The investigators will look at the costs and assess which treatment offers most benefit. The team has experience and ability in this field and will ensure the results are well publicised. Any child can withdraw from the study at any time.
A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma
AsthmaThe purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.
Safety Study of Depigoid Vaccine Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyssinus...
Allergic RhinitisRhinoconjunctivitis2 moreSafety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or rhinoconjunctivitis with or without asthma. Primary variable: number of subjects [%] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI...
AsthmaThe purpose of this clinical study is to compare the improvement in breathing of single administration of CHF 1535 50/6 pMDI (fixed combination of a corticosteroid drug beclomethasone 50 µg + formoterol 6 µg/puff, 2 inhalations, total dose 100/12 µg) given with spacer versus free combination of beclomethasone 50 µg/puff pMDI (2 inhalations, total dose 100 µg) given with spacer plus formoterol 6 µg/puff pMDI (2 inhalations, total dose 12 µg) given with spacer in terms of FEV1 from 0 to 12 hours in asthmatic children. Additionally the study aims to evaluate the effects of doses of CHF 1535 pMDI compared to placebo and the effect on other lung function parameters, to assess the safety and tolerability of CHF 1535 dosages in children.
Reducing Asthma Morbidity In High Risk Minority Preschool Children
AsthmaLow-income, minority children are disproportionately affected by asthma and can experience higher rates of asthma attacks, lower lung function, decreased physical activity, increases in school absenteeism, and higher rates of death. The National Center for Children in Poverty suggests that effective interventions to improve asthma and reduce harm for high risk groups (like low-income minority children) must begin in early childhood. Previous research has shown that asthma education programs can be effective to improve overall asthma management in preschool children, but there has been limited sustainability of these programs in medical, educational, and social environments that serve young high risk children. One of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students and would be an ideal setting in the community to disseminate an early asthma education program. The purpose of this study is to draw on our health and research partnership with Baltimore City Head Start programs to test the effectiveness of a home-based asthma education intervention combined with a Head Start level asthma education program compared to a Head Start level asthma education program alone.
A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From...
AsthmaThe primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high dose ICS therapy.