CDC Medicaid Asthma Home Visit Project
AsthmaAsthmatic children age 3-17 from low income households in King County are randomly assigned into a community health worker (CHW) intervention group and a control group. The intervention is in-home education and support related to asthma self-management. The main outcome measures are asthma symptom-free days, caretaker's asthma-related quality of life score, and health care utilization for asthma measured at baseline and 12 months after baseline enrollment.
The JOIN Project: The Air in Diagnosis and Prevention of Asthma and Allergy
AsthmaAtopyThe JOIN project combines the health and indoor environment research areas to contribute in the development and validation of a new asthma diagnosis method through exhaled VOC analysis. This method is more sensitive, more specific, and completely non-invasive. Moreover, the JOIN project will assess the impact of exposure to the indoor environment, namely endocrine disruptors, on asthma and allergy development in children.
Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis...
Allergic RhinitisRhinoconjunctivitis1 moreThis is an observational prospective study to assess the tolerability and safety of treatment of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at initiation period till maintenance dose is reached) The study population is both: adult and child, polysensitized to at least 2 allergen sources with rhinitis or allergic rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma. The assignment of a patient to a particular therapeutic strategy will not be decided in advanced by a trial protocol but will be determined by routine clinical practice. The decision of the investigator to prescribe a particular treatment will be clearly dissociated from the decision to include the patient in the study. The patients will not suffer any intervention, whether diagnostic or monitoring, other than the usual in clinical practice.
Modelling of the Upper Airway in Children With Controlled Asthma
Controlled AsthmaAsthma in children is recognized as a disease area with a high medical need. As the investigators move into this field it is necessary to improve the investigators knowledge of upper airway anatomical structure in paediatric patients. This study will provide airway/facial morphologies from controlled asthmatic patients. Limited facial morphology can be used in order to build models to study the delivery of medication through a device that requires for example a facemask. In this study the anatomical structure of the upper airway and the facial geometry will be evaluated using a Cone Beam Computed Tomography (CBCT) scan. The scan will be taken in a population of 20 asthmatic children between 6 and 12 years old.
The Development of a Clinical Test to Assess the Inflammatory Phenotype of Asthma
AsthmaThe purpose of this study is to determine the type and degree of inflammatory parameters in peripheral blood of asthma patients compared to analysis of induced sputum. 115 asthma patients visiting the outpatient clinic of the University Medical Center will be included. Blood samples are obtained and sputum induction is performed. Hypothesis: in asthma the analysis of type and degree of inflammation in peripheral blood by changes in phenotypes of leukocytes is at least as reliable as analysis of cells obtained from induced sputum
An Open Label Placebo Study to Assess the Inhalation Profile in Asthmatic Patients Using the Nexthaler®...
AsthmaPhase IIa, single-centre, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler® device in adult asthmatic patients with varying degrees of disease control.
WEUSRTP4850: Phase II: ICS/LABA Use in Pregnancy and Outcomes
AsthmaAsthma is reported to affect between 3-14% of pregnancies making asthma medicines one of the most commonly used classes of medicines during pregnancy. Maternal asthma and in particular poorly controlled asthma has been found to be associated with a number of adverse perinatal outcomes including preterm delivery, low birth weight and pre-eclampsia. At present little is known about the safety in humans of many anti-asthma medicines when used during pregnancy. As a result all inhaled corticosteroids, with the exception of budesonide which is category B, have an FDA pregnancy category C, indicative of the fact there are no adequate and well controlled studies in humans. Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often in combination with the long-acting β-agonist salmeterol. Owing to small numbers of pregnancy exposures in the past, little is known about the safety of fluticasone propionate when used during pregnancy. A recent feasibility study, however, has shown that there are sufficient numbers of first trimester exposed pregnancies on the General Practice Research Database (GPRD) to allow the overall risk of major congenital malformations (MCMs) to be evaluated. This study also demonstrated that using data from the GPRD it is possible to determine an individual's exposure to anti-asthma medicines during pregnancy and to classify her treatment in terms of the British Thoracic Society treatment steps based on linked prescription and primary care data. The aims of this study are to 1) evaluate the safety profile of fluticasone propionate (FP) compared with exposure to all other inhaled corticosteroids with all major congenital malformations combined as the primary endpoint, whilst taking into account potential confounders and exposure to other anti-asthma medicine; and 2) test the null hypothesis that exposure to fluticasone propionate during the first trimester of pregnancy is not associated with increased overall risk of all major congenital malformations when compared to the risk in those exposed to other inhaled corticosteroids during the first trimester of pregnancy. The study will be a retrospective cohort study and will use data from the United Kingdom's General Practice Research Database (GPRD). The GPRD contains longitudinal medical records collected within UK primary care. All medical symptoms and diagnoses are recorded in the database, including those relating to pregnancy, in the form of Read Codes. In addition to coded data GPs have the option of recording un-coded comments ('free text'), such as more detailed descriptions of diagnoses or treatments along with information provided to them via hospital letters, referrals and discharge summaries. As the recording of stillbirths, neonatal deaths and pre-term births on the GPRD has not been verified, a verification exercise will be carried out. This will involve requesting and reviewing free text comments for 100 stillbirths, 100 neonatal deaths and 100 pre-term births. Free text comments will be requested if they are associated with a medical code related to pregnancy, delivery, post natal visits, death, post mortem, hospital letters and other forms of communication. If the free text is not found to be informative we will send questionnaires to the woman's GP. All outcomes will be identified and verified blinded to asthma treatment and severity levels.
Survey on the Effect of Health Related Quality of Life (QOL) Associated With Compliance of Carbocisteine...
AsthmaThe objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients whose control levels are partly controlled or uncontrolled.
Reflux Disease Therapy in the Management of Childhood Asthma-data Entry and Analysis Only
AsthmaGastroesophageal Reflux DiseaseThere have been a number of studies which attribute causality between reflux disease and asthma. In addition, clinicians typically treat chronic asthmatics with high dose acid suppressing medications (e.g. lansoprazole). However, clinical trials only recently have shed some light on this dilemma, with recent studies suggesting that the association is not as clear. This "retrospective" analysis of a prospective study which treated mod-severe asthmatics with lansoprazole or placebo will enter the collected raw data into a database, then perform statistical analyses to determine if children with asthma treated with acid suppression improved their asthma compared to those receiving placebo.
Implementation of a Pediatric-to-adult Asthma Transition Program
AsthmaEducationDespite the clear and often stated need, a formal transition program does not exist for asthma patients as they move from pediatric to adult care in Western Canada. This population is not having their health care needs met. The investigators proposed study would evaluate a well structured transition program designed to facilitate continuity of care for this at risk patient population. Primary hypothesis: A pediatric-to-adult asthma transition program will improve the asthma-specific quality of life of young asthma patients in the Calgary area over a 1 year period. Secondary hypothesis: A pediatric-to-adult asthma transition program will improve asthma control, decrease asthma exacerbations, and reduce health care utilization in young asthma patients in the Calgary area over a 1 year period.