View clinical trials related to Asthma.
Filter by:The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.
SB-240563 is a fully humanized monoclonal antibody which is specific for human interleukin-5 (IL-5) and has been under development for severe refractory asthma. This study is the first study in Japanese subjects. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose SB-240563 administered intravenously to Japanese healthy male subjects.
Asthma is a chronic inflammatory bronchial disorder with three distinct components: airway hyper-responsiveness (respiratory hypersensitivity), airway inflammation, and intermittent airway obstruction. One of the characteristics of the disease is an inflammatory reaction of the immune system caused by cytokine production. A substantial number of asthma patients do not satisfactorily respond to steroid therapy and consequently have an unmet medical need for novel targeted therapies with improved specificity, tolerability, and compliance. Novel therapeutic strategies for the treatment of chronic inflammatory diseases by targeting early disease-causing mechanisms are a promising approach for the treatment of asthma. The transcription factor GATA-3 plays a key role in mediating the asthmatic immune response and has been shown to be necessary and sufficient for the production of cytokines interleukin (IL)-4, IL-5, and IL-13. The active principle hgd40 of the investigational medicinal product SB010 belongs to a new class of antisense oligonucleotide therapeutics, the 10-23 DNA (deoxyribonucleic acid) zymes (antisense oligonucleotide). DNAzymes are catalytically active nucleic acids that cleave complementary RNA (ribonucleic acid) molecules. By cleaving GATA-3 mRNA hgd40 reduces specific cytokine production and thereby reduces key features of allergic airway inflammation. DNAzymes are completely generated by chemical synthesis and can be produced under Good Manufacturing Practice (GMP) controlled conditions. The DNAzymes are not biological drugs, i.e. they are not generated by use of any living organism including cell culture or bacteria. The molecules are highly water-soluble and will be applied as solution directly in their synthesized form. The current study will evaluate the safety and tolerability of increasing single doses of inhaled SB010 in healthy male subjects.
In older children and adults, bronchodilator (BD) dose-effect relationship is part of the characteristics of asthma disease. There are no data on BD dose-response relationship in wheezy preschool children whose disease pathophysiology is poorly understood, but may, in part, takes on the characteristics of asthma. The investigators assume that 1) in young children interrupter resistance (Rint) could be used to measure a BD effect 2) the response to BD may vary depending on the dose used 3) the dose-response relationship could depend on the environment and gene polymorphism ADBR2. This is a prospective phase II study on dose-response relationship and description of the dose-response curve design using a "sparse" and a modeling approach MCP-Mod. The dose-response relationship will be modeled by sparse data. The investigators will test two doses per child in four designs that will be drawn. These doses will be assessed using Rint technique by a person blinded to the actual dose delivered to the child. Measurements of 90 children will estimate E0, Imax and D50 (pharmacokinetic constants) with an accuracy of 3.5%, 8.9% and 25.7% respectively. The bronchodilator used in the study is the Salbutamol as Ventolin ® (GSK) suspension for inhalation as an aerosol at a dose of 100μg per puff. Ventolin ® is used as part of the MA (No. 344 387-3)
Background: - Cockroach allergies are an important risk factor for asthma in inner-city households, especially in children. A new method for killing cockroaches may help children who live in households that have high numbers of cockroaches. Because most public health treatments target more than just cockroaches, this method could lower the costs of treating childhood allergies and asthma by focusing on the most likely source of the allergy. Objectives: - To test a new cockroach-killing method designed to reduce asthma in children exposed to cockroaches. Eligibility: - Children 5 to 14 years of age who have moderate to severe asthma. - Children must live in a household that has a high number of cockroaches. Design: - Participants will be screened with a phone call and an initial home visit. - Study doctors will place cockroach traps, and return after 3 days to check the number of roaches caught and killed. Dust samples will be collected from the house. - Participants will have blood and lung function tests, and will be tested for allergies (including cockroach allergies). - Some households will be treated for cockroaches at regular intervals, or more frequently if required by the study doctors. - Participants will have regular checkup visits in their homes at months 1, 3, 6, 9, and 12 and short phone call interviews at months 2, 4, 6, 8 and 10 to study their asthma symptoms. The home visits will also check the cockroach levels in the house.
This is a pharmacokinetic comparison of CHF 1535 50/6 NEXT DPI versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.
The study will comprise three Parts: Part A will consist of two cohorts of healthy male volunteers to assess the safety, tolerability and pharmacokinetics of ascending single doses of nebulised GSK2269557. Blinded safety and available PK data will be reviewed before each dose escalation. Part B will be one cohort to examine the safety, tolerability and pharmacokinetics of a repeated dose of GSK2269557 given by nebuliser for 7 days in healthy male volunteers. The total daily dose will be the same as, or lower than, doses that are well tolerated in Part A. Part C will consist of two cohorts of single nebulised doses in healthy male smokers, to assess pharmacodynamic endpoints in sputum and bronchoalveolar lavage.
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
The purpose of the study is to establish and clinically evaluate a new approach to treating asthma by using information and communication technologies (ICT). A mobile environment, and organizational interventions to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated.
A retrospective database analysis to evaluate the impact of omalizumab on the use of corticosteroid, emergency-department visits and hospitalizations among patients with uncontrolled asthma and using high-dose Inhaled Corticosteroids (ICS) prior to initiating omalizumab.