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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT01376830 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Characteristics That Identify Exacerbation Risk Following Colds in COPD Patients

Start date: June 2011
Phase: N/A
Study type: Observational

Respiratory virus infections are a common cause of COPD exacerbations and antiviral therapies have potential as treatments for exacerbations. However it is likely that treating patients when they present with an exacerbation with antiviral drugs will be too late to be effective and earlier treatment at the time of the initial upper respiratory tract infection (URTI) will be required. The incidence of exacerbations following URTIs in COPD patients, and whether there are host factors and biomarkers that can identify the risk of this, is unknown. The aims of this study are to establish the proportion of viral URTIs that progress to an acute exacerbation in COPD patients and identify clinical, viral and biological markers that predict risk of an exacerbation following an URTI. In addition we will determine the frequency of, and risk factors for, bacterial infection following viral URTIs in COPD patients. This data will permit development of a model combining baseline patient characteristics, clinical measurements and biomarkers to predict exacerbation risk following viral URTI in COPD patients. The results will open the way for trials of antiviral therapy in COPD exacerbations and targeting of treatment to high risk patients.

NCT ID: NCT01376388 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Long-term Safety Study for GSK573719/GW642444 in Japanese

DB2115362
Start date: August 2011
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444 Inhalation Powder 125/25 mcg once-daily. The product will be delivered via the Novel Dry Powder Inhaler (nDPI) over 52 weeks to Japanese subjects with Chronic Obstructive Pulmonary Disease (COPD). This is a multi-centre, open-label study evaluating the safety of GSK573719/GW642444 Inhalation Powder 125/25 mcg. Treatment will be given once-daily in the morning. The target enrolment is approximately 120 subjects at approximately 20 study centres in Japan. The total duration of subject participation will be 54-55 weeks, consisting of a 7-14 day run-in period, 52-week treatment period and 1-week follow-up period. Subjects meeting all of the inclusion criteria and none of the exclusion criteria at screening visit (Visit 1) will enter 7-14 day run-in period. The run-in period is provided for completion of baseline safety evaluations and to obtain baseline measures of COPD status. At Visit 2, eligible subjects will start to take GSK573719/GW642444 125/25 mcg, and enter the treatment period. This treatment will be delivered via the Novel Dry Powder Inhaler (nDPI) once daily in the morning for 52 weeks. One nDPI will contain 30 doses of study medication. Subjects will be instructed to administer medication once daily in the morning for the duration of the 52-week treatment period. Each subject should be advised to adhere to this dosing regimen throughout the study. There will be a total of 8 study visits including at screening (Visit 1), initiation of treatment (Visit 2), and at 4weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks (Visit 3 through Visit 8, respectively). Follow-up (Visit 9) will be conducted by the phone contact approximately 1 week following the completion/withdrawal of treatment period. A subject will be considered to have completed the study upon completion of the last on-treatment visit (Visit 8). At the end of the treatment period, subjects will be prescribed appropriate COPD medication at the investigator's discretion.

NCT ID: NCT01372462 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease

Start date: July 2011
Phase: N/A
Study type: Interventional

Pilot study in 10 stable male subjects with severe-to-very severe Chronic Obstructive Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe Technologies ventilation system on respiratory mechanics during constant work rate exercise in subjects with severe COPD. Two healthy male control subjects will also be evaluated in orde to validate the data collection system.

NCT ID: NCT01372410 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)

AC4115321
Start date: July 1, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to further characterize the dose response of GSK573719 at doses of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive pulmonary disease (COPD). Treatment with doses of GSK573719 dosed twice daily will also be included to further evaluate dosing frequency. Treatment with tiotropium (18 mcg) once daily via the Handihaler will be included as an active control. A placebo treatment will be included in order to evaluate absolute treatment effect of the different doses of GSK573719.

NCT ID: NCT01372072 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Investigate the Effects of Heated Humidification During Non-Invasive Ventilation

Start date: February 1, 2012
Phase: N/A
Study type: Interventional

Noninvasive ventilation (NIV) is a form of ventilation delivered by a mask and is an important mode of treatment in patients with both acute and chronic respiratory (breathing) failure. Humidification is widely accepted as an essential part of the ventilation strategy in patients receiving invasive ventilation (i.e. via a tube inserted into the mouth), but its role during NIV use is not proven. Consequently, there is a variation in practice with regard to humidification during NIV. Humidification is important in maintaining upper and lower airway mucosal function and patients requiring NIV often report symptoms, such as throat dryness, due to a lack of airway humidity. Success of NIV in the acute setting is dependent on many factors including, patient tolerance of NIV during the acute phase. In patients with chronic obstructive airways disease (COPD), poor tolerance results in NIV failure, which necessitates endotracheal intubation or treatment failure. Furthermore, invasive ventilation increases the risk of a hospital acquired pneumonia, which is associated with a worse outcome. In the long term setting of NIV use, again patients frequently report symptoms due to drying of the airways and adherence to NIV can be highly variable. Adherence in these patients is important in improving both quality and length of life. Humidification devices may be technically effective, but clinicians have concerns regarding potential negative effects of these devices. There is a requirement to evaluate the use of humidification in both the acute and long term use of NIV, particular, in terms of patient ventilator interaction, which will impact on comfort and adherence to NIV. This will effect the overall effectiveness of ventilation. The investigators propose a randomised controlled trial to investigate the effects of a humidification system during noninvasive ventilation.

NCT ID: NCT01371149 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Patient -Ventilator Interaction in Chronic Respiratory Failure

Start date: January 2011
Phase: Phase 2
Study type: Interventional

To evaluate a novel advanced physiological monitoring system to improve nocturnal non-invasive ventilation (NIV) in Neuromuscular disease (NMD), Chest wall disease (CWD), Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) patients. By enhancing sleep comfort, adherence to ventilation will increase which, in turn, will improve ventilatory failure, quality of life and reduce length of admission during initiation of therapy. We aim to incorporate this technology into routine clinical practice.

NCT ID: NCT01371097 Completed - Clinical trials for Neurological Diseases

Progressive Resistance Strength Training (PRT) in Hospitalised Elderly Patients

B15
Start date: September 2006
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the effect of progressive resistance strength training (PRT) in elderly hospitalised patients. The hypothesis is that PRT given as an additional training would improve the rehabilitation and increase the level of activity of daily living.

NCT ID: NCT01369810 Completed - Asthma Clinical Trials

Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or Chronic Obstructive Pulmonary Disease

Start date: July 2011
Phase: N/A
Study type: Observational

To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure

NCT ID: NCT01366469 Completed - Clinical trials for Coronary Artery Disease

Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting

CABG BALF
Start date: April 2011
Phase: N/A
Study type: Observational

The primary objective of this pilot study is to identify and quantify inflammatory and genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history of chronic obstructive pulmonary disease (COPD) undergoing elective coronary revascularization (CABG) to determine the risk of developing post operative respiratory failure. To achieve this objective, this proposal outlines the following specific aims: Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at the time of intubation immediately prior to surgery and again upon skin closure immediately after the surgical procedure. Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with post-operative pulmonary complications defined as prolonged mechanical ventilation (> 24 hours), pneumonia, and/or tracheostomy. Aim #3. To inform the development and implementation of a large pivotal trial which may impact clinical decision-making during the initial pre-operative outpatient assessment of COPD patients undergoing CABG.

NCT ID: NCT01365702 Recruiting - Tuberculosis Clinical Trials

Tiotropium in Patients With Tuberculosis (TB) Destroyed Lung

Start date: June 2011
Phase: N/A
Study type: Observational

The aim of this study to evaluate clinical efficacy of tiotropium in patients with airflow obstruction due to Tuberculosis (TB) destroyed lung.