
Interactive Tool to Support Self-management Through Lifestyle Feedback, Aimed at Physical Activity...
Chronic Obstructive Pulmonary DiseaseType 2 DiabetesRationale: Physical activity is an important factor for a healthy lifestyle. Although physical activity can delay complications and decrease the burden of the disease in chronically ill persons, their level of activity is often far from optimal. Many interventions have been developed to stimulate physical activity, with disappointing results. New in this field is the use of technology. Human persuasion (for example guidance by a practice nurse) can be enhanced by technological persuasion. Therefore a monitor and feedback tool, consisting of an accelerometer linked to a smart phone and webserver, has been developed and tested. Objective: The main objective of this study is to measure the effects of the monitoring and feedback tool embedded in a Self-management Support Program on physical activity. The secondary objective is to measure the effect on self-efficacy, quality of life and health status. In addition a process evaluation will be conducted. Study design: A three-armed cluster randomised controlled trial will be conducted with 240 patients from 24 general practices. Randomisation level is the practice. The following conditions will be compared: 1) Tool and Self-management Support Program; 2) Self-management Support Program; 3) Care as usual. Outcome measures will be measured at t0 (before the start of the intervention), t1 (after 6 months, at the end of the intervention) and t2 (after 9 months). Study population: 120 People with COPD and 120 people with Diabetes type 2 (aged 40-70) treated in primary care will be included from 24 GP practices. Intervention: Spread over a period of six months patients in condition 1 and 2 have to visit the practice nurse for 3-4 times for physical activity counselling. Specific activity goals will be set that are tailored to the individual patient's preferences and needs. On top of this, patients in condition 1 will be instructed to use the monitoring and feedback tool in daily life. Patients in condition 3 will not be exposed to any intervention. Main study parameters/endpoints: Primary outcome: physical activity measured with a physical activity monitor (PAM). Secondary outcomes: quality of life, general self-efficacy, exercise self-efficacy and health status.

A Novel Unidirectional Face Mask During NPPV in COPD Patients
Chronic Obstructive Pulmonary DiseaseThe purpose of this study is to determine the feasibility, safety and efficacy of a unidirectional breathing mask (breathe in through the nose and out through the mouth or breathe in through the mouth and out through the nose) in COPD patients with breathing difficulties requiring noninvasive positive pressure ventilation (NPPV).

Effect of Steroids on Gene Expression in the Healthy Smokers Lungs
Chronic Obstructive Pulmonary Disease (COPD)Cigarette smoking is the main risk factor for chronic obstructive pulmonary disease (COPD). The cells lining the lung airways (epithelium) and the cells on the surface of the epithelium (alveolar macrophages) of healthy smokers develop characteristic gene expression changes that are different from that of nonsmokers. These gene expression changes include up- and down-regulation of genes in functional categories known to be relevant to the development of COPD. Administration of anti-inflammatory medications (inhaled steroids) in combination with long acting medications that open the airways (bronchodilators), are known to decrease the rate of acute exacerbations and improve the quality of life of individuals with COPD; however, the mechanisms underlying these beneficial effects of are poorly understood. This study will assess the effect of traditional therapy for COPD (inhaled corticosteroids, an anti-inflammatory medication, plus a bronchodilator, a medication that helps open the airways) on smoking-induced gene changes in airway epithelium and alveolar macrophages. Volunteer subjects will be evaluated by bronchoscopy to sample lung cells at 0, 7 and 14 days, with the therapy given at day 1 through day 7. The bronchoscopy aspects of this study will be covered by approved Weill-Cornell IRB protocol # 0005004439 (see below.) To participate in this protocol, the research subject will first be enrolled in Weill-IRB protocol #0005004439 entitled "Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy", fulfilling the inclusion/exclusion criteria of that protocol. They will be invited to participate in this protocol only if they meet the additional inclusion/exclusion criteria of this protocol.

A 12 Week Physical Training Programme for Patients With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary DiseaseThe purpose of this study is to determine whether water based or land based group training is more effective for people with COPD.

Trial Comparing Effect of He/O2 to Medical Air on Pulmonary Function Disease
AsthmaChronic Obstructive Pulmonary Disease1 moreThis clinical trial will include healthy volunteers, COPD patients and asthmatic patients who will breathe He/O2 78:22, He/O2 65:35 and medical air consecutively in a randomised order.

A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure...
Heart FailureChronic Obstructive Airway DiseaseThis study looks at the effect of two drugs (carvedilol and metoprolol) which are used for patients with CHF (chronic heart failure). These agents are beta-blockers and, although effective in heart failure, may cause increases in airways tone and thus limit air getting into the lower parts of the lungs. Carvedilol is more active at blocking the receptor that opens up the airways and therefore theoretically may be more likely to reduce airways tone than metoprolol, although this has never been studied in patients with heart failure, and that is the purpose of the present study. We are looking to enrol 45 patients with heart failure and mild obstruction to the flow of air in their lungs. Patients will be randomised to either carvedilol or metoprolol (standard doses). Following a minimum of 2 weeks of therapy of study medication the patient will undergo a study day involving an assessment of their lung function, an assessment of their heart failure, a "living with heart failure" questionnaire, blood tests and blood pressure and heart rate readings. Patients will then be crossed over to the alternate medication. Following 2 weeks on the target dose the patient will undergo their second study day which will be the same as the first. The results obtained from each study day will be compared.

Replacement of Nebulised Ipratropium With Inhaled Tiotropium in Stable Chronic Obstructive Pulmonary...
Chronic Obstructive Pulmonary DiseaseSome patients with chronic obstructive pulmonary disease (COPD) take nebulised treatments to ease the symptom of breathlessness, including the drug ipratropium. Nebulised bronchodilator drugs are taken up to 4 times through the day, and this can take up to 15 minutes each time. Although the treatment isbe effective, patients report that the time taken to set-up and use the nebuliser can be a disincentive to regular use. By contrast, an inhaler device is easy to use following appropriate instruction, and takes only a few seconds to administer. Inhaled tiotropium is a once daily treatment taken by inhaler which has been shown to be effective in COPD. We wish to assess whether inhaled Tiotropium as effective as nebulised ipratropium in patients with stable chronic obstructive pulmonary disease.

Aridol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD
Lung DiseasesObstructiveThe purpose of this study is to determine whether the Aridol (mannitol) challenge test can predict response to treatment with inhaled corticosteroids in COPD subjects. Subjects will undergo an Aridol test and then 3 months of treatment with inhaled corticosteroids. The effect on lung function and quality of life will then be measured and correlated with the Aridol test result.

Chinese Community Smoking Cessation Project
Cardiovascular DiseasesHeart Diseases3 moreThe study has two objectives/aims: Aim 1: To test the efficacy of the intervention among adult smokers with cardiovascular disease, pulmonary disease and diabetes mellitus related illnesses (later modified to Chinese adults with and without diseases); and Aim 2: To examine a set of measures (background, general health, psychosocial, and smoking process) that are associated with smoking cessation at 6 and 12 months

A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects
AsthmaBronchial4 moreThis study (A7881006) is the first multiple dose study in moderate asthmatic subjects and aims to determine the safety and efficacy of PF-00610355 when subjects take PF-00610355 on a daily basis for 4 weeks in subjects maintained on inhaled corticosteroid.