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Respiratory Tract Diseases clinical trials

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NCT ID: NCT01295866 Completed - Rhinitis Clinical Trials

Evaluation Effects of Nasal Nitric Oxide Measurements Are Associated With Atopy Status in Chronic Nasal Inflammation

Start date: January 2010
Phase: Phase 1
Study type: Observational

Nitric oxide (NO) was considered as a mediator of nasal inflammation and the measurement of nasal nitric oxide (nNO) may assist in the diagnosis of nasal inflammation. Few data exists comparing nNO with established, larger accepted reference standard for chronic rhinosinusitis (CRS) diagnosis. Moreover, the role of atopic status on nNO in nasal inflammatory diseases has not been reported. The aim of our study was to determine the value of nNO in patients with chronic nasal inflammation, and to assess the relationship between nNO and atopic status in these patients. A total of 131 randomized patients suffering form chronic nonallergic nasal inflammation and 20 healthy volunteers were finally recruited. nNO was measured by NIOX devices. Sinus computed tomography (CT) scan, nasal endoscope and nasal symptoms evaluation were used in the different diagnosis of chronic rhinitis (CR), CRS without nasal polyps (CRSsNP) and CRS with nasal polyps (CRSwNP). Atopic status was confirmed by skin prick test and serum IgE levels. Blood eosinophils were evaluated simultaneously. Relationships among nNO, various atopic characteristics and chronic nasal inflammation were evaluated.

NCT ID: NCT01295255 Completed - Allergic Rhinitis Clinical Trials

Interaction Effect of Asthma and Aeroallergen Category on the Psychological Status in Allergic Rhinitis Patients

Start date: February 2009
Phase: N/A
Study type: Observational

Allergic rhinitis (AR) and asthma are considered as "one airway, one disease". Although there is increasing evidence for an association between allergy and depression, it remains unknown if the relationship between AR and asthma has extra influence on the psychological status of the patients. The aim of our study was to investigate the influence pattern of asthma on the psychological status in AR patients. The Symptom Checklist-90 (SCL-90) was employed to analyze the psychological status of 524 individuals with AR. Independent sample T-tests, one-way ANOVA and multivariate ANOVA were used for data analyses.

NCT ID: NCT01283009 Completed - Clinical trials for Community Acquired Respiratory Disease Syndrome

Extended Steroid in Use in Community Acquired Pneumonia (CAP)(e)

ESCAPe
Start date: January 9, 2012
Phase: Phase 3
Study type: Interventional

The goal of the study is to determine whether providing early treatment with a glucocorticoid drug, called methylprednisolone, will improve survival in critically ill patients with severe community-acquired pneumonia (CAP). Pneumonia develops when bacteria and other agents invade the lungs. The body's immune system creates a response to produce inflammation to kill the bacteria. A moderate amount of inflammation is beneficial. But, in patients sick enough to be admitted to the ICU, inflammation is frequently out of control. When the body cannot regulate inflammation vital organs (brain, heart, lung, kidney, liver) may be damaged, contributing to death or residual organ damage for those who survive. Glucocorticoids help reduce inflammation. Recent studies have shown that when the body is unable to produce sufficient amounts of glucocorticoids, inflammation can get out of control. Under these circumstances, glucocorticoids given in small doses may help aid the body's ability to reduce inflammation and improve recovery. In a small preliminary trial, glucocorticoid treatment, in addition to standard antibiotic treatment, sped up recovery from pneumonia. It also decreased the length of hospital stay, and increased survival. This Cooperative Studies Program (CSP) study will be the first large-scale, prospective, randomized clinical trial evaluating whether or not this treatment improves recovery. In this study, at each site, patients with severe CAP will be assigned to one of two treatment groups. One group will receive methylprednisolone and the other will receive a placebo (an inert substance that will look like the drug). The investigators have chosen a total duration of treatment of 20 days (7 days full dose followed by slow reduction over 13 days) to prevent relapse of inflammation and allow the body to recover its own ability to produce glucocorticoid. All patients will also receive standardized management of CAP in accordance with current practice guidelines. The study will take into consideration when assigning the treatment each participating site, and whether or not the patient requires mechanical ventilation at the time of assignment. Patients will be followed clinically for 180 days. The primary outcome is all cause 60-day mortality. Secondary outcomes are (1) in-hospital morbidity-mortality, including ventilator-free days, multiorgan dysfunction syndrome (MODS)-free days, duration of ICU and hospital stay, and hospital discharge; and (2) posthospital discharge morbidity-mortality, including cardiovascular complications, functional and general health status in the first 180 days, rehospitalization, and mortality at 1 year. Serial blood samples will also be collected and stored for future translational research relating longitudinal inflammation markers to clinical outcomes. This study will advance knowledge on the relationship between inflammation and long-term outcome in severe CAP.

NCT ID: NCT01264055 Completed - Infection Clinical Trials

Cross-sectional Characterization of Idiopathic Bronchiectasis

Start date: April 26, 2011
Phase:
Study type: Observational

Background: - Bronchiectasis is a type of lung condition in which the lungs airways are abnormally stretched and widened. This stretching and widening makes it difficult for mucus and other substances to move out of the lungs, encouraging the growth of bacteria and leading to breathing problems or infection. Bronchiectasis can be caused by genetic disorders or diseases such as tuberculosis or rheumatoid arthritis. Researchers are interested in developing better ways to diagnose and treat a lung problem called idiopathic or unexplained bronchiectasis. Objectives: - To better describe the physical characteristics, radiographic patterns, and airway microbiology of unexplained bronchiectasis and to look for possible genetic links or risk factors. Eligibility: - Individuals at least 18 years of age who have a chronic cough and who have had a CT scan that has revealed signs of bronchiectasis. - Current smokers or those who have smoked for at least 10 years, as well as individuals who have known causes of bronchiectasis or who have had organ transplants, are not eligible to participate. Design: - Participants will have one outpatient clinic visit for evaluation with a physical examination including detailed body size measurements and medical history and for collection of blood samples for routine lab tests and genetic analyses and a chest x-ray if no recent one is available. - Participants will also have tests of lung function, and measurement of a gas called nitric oxide in the nose. Participants whose initial tests show abnormal results may also be asked to have a nasal scrape to collect cell samples and/or a skin sweat test to measure salt concentrations. - Participants will also have a sputum specimen collected during the visit and will be asked to collect two additional early morning sputum samples and a mouth rinse at home within 2 weeks of the clinic visit, and mail the sample collection materials to the research team....

NCT ID: NCT01255592 Completed - Bronchiectasis Clinical Trials

Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis

STRATUS
Start date: February 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.

NCT ID: NCT01244867 Completed - Clinical trials for Respiratory Tract Infections

Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The primary objective is to assess the immunogenicity and safety and tolerability of two consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®, compared to the placebo, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80).

NCT ID: NCT01196533 Completed - Diabetes Clinical Trials

A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters

Start date: August 2010
Phase: N/A
Study type: Interventional

1. Aim: The aim of the clinical trial is to study the accuracy of the TensorTip device compared with registered (FDA-approved) invasive and non-invasive devices. 2. Hypothesis: Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the TensorTip finger-mounted device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration.

NCT ID: NCT01156701 Completed - Asthma Clinical Trials

Prophylactic Efficacy of Relenza Against Influenza A and B

Start date: July 2009
Phase: N/A
Study type: Observational

In response to the European regulatory authorities, GSK is conducting a post-marketing observational study to assess the efficacy of Relenza when used as prophylaxis against influenza. SPECIFIC AIMS 1. Determine the frequency of patients who received Relenza from October 2006 through April 2009, and among them the number who have no concurrent diagnosis of influenza, i.e., those receiving Relenza for prophylaxis, and among these the number who have a family member with a medical visit for influenza within three days preceding the above indentified patient's dispensing of Relenza. This is to determine the feasibility of conducting detailed analysis. 2. If analysis is feasible then tabulate the frequency of influenza-like-illness and respiratory outcomes in users of prophylactic Relenza and their family members and in family members of persons using Relenza for the treatment of influenza (i.e., index cases). 3. If analysis is feasible then estimate the direct effect of prophylactic Relenza on the occurrence of influenza-like-illness and respiratory outcomes, the secondary effect of Relenza treatment of influenza on susceptible family members, and the total effect of Relenza (treatment plus prophylaxis). METHODS Overview of Study Design This is an analysis of the 30-day risk of influenza-like illness and respiratory outcomes in persons for whom some household members (index cases) have had a medical visit associated with a diagnosis of influenza. The exposed individuals to the index case will be categorized into one of four cohorts according to whether the exposed person received prophylactic Relenza or no antiviral treatment and by whether the index family member with a diagnosis of influenza received antiviral treatment. Estimates of the direct effect of Relenza prophylaxis, the indirect effectof preventing disease in susceptible family members, and the total effect of disease reduction when both index cases and susceptible family members are treated will be obtained from different comparisons between cohorts, as outlined below. The research will cover the first three influenza seasons during which Relenza has been indicated for prophylactic use in the United States. These will be from October through April of 2006-2009.

NCT ID: NCT01113255 Completed - Clinical trials for Respiratory Diseases

Validation of a Simulated Clinical Evaluation of Ventilators

SIMULVENTI
Start date: March 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the ability of a device reproducing patients' respiratory characteristics to select in-VITRO the most appropriate ventilator for a given pathology.

NCT ID: NCT01047852 Completed - Respiratory Failure Clinical Trials

Noninvasive Ventilation After Extubation in Hypercapnic Patients

VHYPER
Start date: January 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.