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Asthma clinical trials

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NCT ID: NCT01641211 Completed - Asthma Clinical Trials

ENLaCE Pilot Study

Start date: July 2012
Phase: N/A
Study type: Interventional

This is a feasibility study to determine whether the Expanding Networks for Latinos through Community Engagement (ENLaCE) can be used to recruit Latino children into a randomized, controlled trial (RCT) to improve their asthma medication device technique. Children will be recruited from two pediatric ENLaCE clinics in Greensboro and randomly assigned to watch device technique videos (experimental group; n=50) or a nutrition video (control group, n=50) in Spanish or English after a regularly-scheduled medical visit. Children's device technique will be assessed before and after the visit. Process evaluation data will also be collected. The investigators hypothesize that children in the intervention group will have better device technique post-intervention than the control group.

NCT ID: NCT01641081 Completed - Asthma Clinical Trials

Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma

Start date: June 2012
Phase: Phase 2
Study type: Interventional

The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma. This study will include a screening visit followed by a 4 month treatment period.

NCT ID: NCT01636726 Completed - Asthma Clinical Trials

WEUKBRE5554: IMI PROTECT(Work Package 2): Beta2 Agonists and Acute Myocardial Infarction

Start date: March 2012
Phase: N/A
Study type: Observational

The studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Work Package 2 and Workgroup 1. Primary aim of these studies is to develop, test and disseminate methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE) studies applicable to different safety issues and using different data sources. To achieve this, results from PE studies on five key adverse events (AEs) performed in different databases will be evaluated. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of the association under investigation . Asthma and chronic obstructive pulmonary disease (COPD) are the most common chronic airway diseases in the western world. For both, a stepwise treatment to reduce symptoms, improve lung function, and prevent risk of exacerbation is recommended using several drug classes according to guidelines published by e.g. the Global Initiative for Asthma [GINA guideline] and the Global Initiative for Chronic Obstructive Lung Disease [GOLD guideline], respectively. Beta-2-adrenoceptor agonists (B2A) are therapeutic mainstays in treating asthma and COPD due to their bronchodilative effects mediated by B2A. This drug class consists of two types of drugs: short acting B2A (SABA) which are used as a reliever medication and long acting B2A (LABA) which are used as maintenance / controller medication. Formoterol and salmeterol are the most frequently used LABA compounds with a half-life between 5-15 hrs and therefore, these compounds most commonly have labelled indications for use twice a day. . Focussing on cardiac side effects of B2A one must consider that drugs with an opposite mechanism of action (beta-adrenoceptor-antagonists) have well-known cardio protective effects and are widely used in patients suffering from e.g. ischemic heart disease, hypertension and acute myocardial infarction (AMI)). Conversely, stimulation of cardiac beta-adrenoceptors as done by B2A may have deleterious cardiovascular effects particularly in patients with cardiac risk factors. And in fact, tachycardia and arrhythmias are well-known side effects of B2A confirming a cardiac influence of these drugs particularly after oral therapy (due to a high systemic exposure) as stated in the respective summary of product characteristics (SPCs), e.g. clenbuterol (Spiropent(R)). Obviously, inhaled drugs cause much smaller systemic exposure but cardiac side effects (e.g. arrhythmias, tachycardia) are also described in the respective SPCs (e.g. formoterol [Foradil(R)). Furthermore, cardiac side were also reported after exposure with inhaled MA (e.g. ipratropium [Atrovent(R)]. Several observational studies have been performed on the association between the usage of inhaled B2A and the occurrence of AMI. However, these studies have produced conflicting results. Reasons for this variation are numerous, e.g. small number of events (AMI) leading to poor precision of risk estimate, potential misclassification of potential cardiac events versus airway-related events due to similar clinical complaints, differences in populations of drug users, measurement of drug exposure, and background risk of AMI. Additionally, a consensus document was released in 2000, redefining AMI. To make comparing results possible, this protocol gives guidelines for conducting studies in the same way in five databases and across 3 designs (cohort, nested case-control, case-cross-over) on the association between inhaled LABA use and AMI. The main focus is to evaluate the impact of study design, population and database characteristics on the association between inhaled LABA and AMI. Data will be collected from the following databases: The Health Improvement Network (THIN), the General Practice Research Database (GPRD), the Dutch Mondriaan project, Base de Datos para la Investigación Farmacoepidemiológica en Atencion Primaria (BIFAP), the National Databases of Denmark, and the Bavarian statutory health insurance physicians' association database.

NCT ID: NCT01635738 Completed - Asthma Clinical Trials

Probiotics and Allergic Diseases

probiotics
Start date: December 2011
Phase: N/A
Study type: Interventional

Many studies had demonstrated that probiotics could be applied in the prevention and adjuvant treatment for allergic diseases. In this study, we investigate the effects of Lactobacillus paracasei GMNL-133(LP), Lactobacillus fermentum GM-090 (LF), and Lactobacillus paracasei GMNL-133(LP) with Lactobacillus fermentum GM-090 (LF) combination products used for adjuvant treatment of atopic dermatitis and asthma.

NCT ID: NCT01635361 Completed - Hypertension Clinical Trials

Understanding and Appraising the New Medicine Service in England

NMS
Start date: August 2012
Phase: N/A
Study type: Interventional

About 25% medicines prescribed for long term conditions are not taken as directed, and approximately 15% people receiving a new medicine take few, if any, doses. The New Medicine Service (NMS) is a community pharmacy service that started in England in October 2011 which involves the pharmacist providing additional support to patients starting a new medicine for some breathing problems (asthma & COPD), high blood pressure, adult onset diabetes or medicines which reduce blood clotting. It aims to improve the way patients take their medicines improving outcomes and reducing costs to the National Health Service (NHS). The investigators will assess the effectiveness and cost effectiveness of the NMS using a research study where some people will receive the NMS, and some won't, so The investigators can look at the effect of the NMS on problems with their medicines, medicines taking and use of the NHS in general. Data will be collected in the East Midlands, South Yorkshire and London areas. The investigators will recruit 500 patients from a range of different pharmacies and follow them up at six, ten and twenty six weeks after starting their new medicine to assess effects on medicines taking behaviour, patients' reported problems with medicines, referrals to their General Practitioner (GP) and use of NHS resources. The investigators will compare the data gathered from this study with that being collected routinely by all pharmacies in England to provide wider estimates of cost effectiveness. The investigators will also explore how the NMS service is being implemented by pharmacies. A sample of patients from the main study will be followed in more detail. This will involve recording the consultations with the pharmacist and also interviewing patients about their experience of the service. The investigators will interview the patients GP to investigate their views of the service. The investigators will also try to understand why people decline the invitation for the NMS

NCT ID: NCT01635088 Completed - Asthma Clinical Trials

Onset and Duration of Mometasone by Oscillometry and Spirometry

Start date: June 2011
Phase: Phase 4
Study type: Interventional

Inhaled corticosteroids (ICS) are appreciated for their long term anti-inflammatory effects in chronic asthma. However, they also have largely unappreciated early effects when initiated as a controller therapy in a steroid-naïve population. Impulse oscillometry might reveal such an early effect better than spirometry. The investigators sought to examine the onset of action and sustained effects over 4 weeks treatment of mometasone furoate as measured by Impulse Oscillometry System (IOS) versus spirometry.

NCT ID: NCT01634958 Completed - Dose-Finding Study Clinical Trials

Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma

Start date: October 2012
Phase: Phase 2
Study type: Interventional

Specific immunotherapy for IgE mediated sensitization to grass pollen 4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the optimum dose.

NCT ID: NCT01634334 Completed - Asthma Clinical Trials

Improving Household Air Quality in Homes With Children

ProjFreshAir
Start date: May 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if real-time feedback (lights/sounds) from small smoke particle monitors and brief coaching will encourage parents to reduce young children's secondhand tobacco smoke exposure in their home.

NCT ID: NCT01634152 Completed - Asthma Clinical Trials

Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.

NCT ID: NCT01634139 Completed - Asthma Clinical Trials

Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.