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Chronic Disease clinical trials

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NCT ID: NCT01313676 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease

Start date: January 25, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.

NCT ID: NCT01313650 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 24-week Evaluation of GSK573719/Vilanterol (62.5/25mcg) and Components in COPD

DB2113373
Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).

NCT ID: NCT01313637 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD

DB2113361
Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).

NCT ID: NCT01309295 Completed - Clinical trials for Anemia, Kidney Disease, Chronic

An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis

Start date: November 2010
Phase: N/A
Study type: Observational

This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.

NCT ID: NCT01308476 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

SMS Reminder to Assess Adherence

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

6 months open label non-interventional observational study acc to § 4, section 23 and § 67, section 6 German Medicines Act with two parallel groups 1. the SMS group receiving a daily SMS - a reminder to inhale Spiriva® 18 Microgram 2. the control group not receiving a daily SMS reminder

NCT ID: NCT01297075 Completed - Chronic Disease Clinical Trials

Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial

Output
Start date: March 2011
Phase: N/A
Study type: Interventional

The aim of this project is to motivate and support general practice clinics in implementing the visions and recommendations presented in two of the disease specific programmes for chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These programmes describe evidence based treatment and division of tasks between the municipalities, the hospitals and general practice. The Facilitator Project is funded by The Danish Ministry of Interior and Health.

NCT ID: NCT01286831 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Single Dose Study to Determine the Excretion, Balance and Metabolic Disposition of Radiolabelled GW642444.

Start date: May 18, 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterise the metabolic disposition of radiolabelled GW642444 when administered orally.

NCT ID: NCT01283685 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Breathing Helium-Hyperoxia During Exercise in Patients With Chronic Obstructive Pulmonary Disease

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

Regular exercise can help patients with the lung disease, chronic obstructive pulmonary disease (COPD). But COPD patients have a hard time with training because of their breathing. To improve their program they can train with one leg at a time. Another way is to make their exercise easier by breathing helium. Putting two methods, one-legged and helium, together may improve their program even more. This project is planned to assess whether breathing helium improves their one-legged exercise endurance. If it does, then there may be a reason for combining one-legged exercise with breathing helium as part of their respiratory rehabilitation program. The aim of this study is to determine whether breathing helium-hyperoxia enables a further increase in the constant power endurance time during one-legged exercise in ventilatory limited subjects with COPD. The null hypothesis is that patients will have sufficient peripheral muscle limitation that ventilatory unloading using helium-hyperoxia will be of no additional benefit to exercise tolerance. The investigators hypothesize that patients with COPD are so ventilatory limited relative to their peripheral muscles that helium-hyperoxia will improve their exercise endurance.

NCT ID: NCT01277614 Completed - Diabetes Clinical Trials

Therapeutic Lifestyle Modifications to Reduce Burden of Chronic Disease

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

The investigators previously established that there was a high burden of disease among all categories of staff at the University of the West Indies, St. Augustine and in many ways, this group is typical of the working class of the Caribbean population. Many had poor lifestyle behaviors, 23.8% had Metabolic Syndrome (MS) with many having one or more MS components. Since most time is spent at work, the workplace is understandably the most logical location to address issues pertaining to health, disease prevention and wellness and on-site programs have yielded many health and other benefits to employees and employers alike. Onwards of the 1980s, numerous studies have been done on work-site intervention programs and these have shown that if a company is able to identify employees at risk for developing health problems and then intervene, health risks and the resulting medical problems are reduced. Such a program, if tailored to meet the needs of participants, may yield similar benefits among the staff of the University of the West Indies.

NCT ID: NCT01274507 Completed - Asthma Clinical Trials

A Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease

Start date: July 2010
Phase: Phase 0
Study type: Interventional

The purpose of this study is to characterize the clinical, physiologic, and molecular profiles of healthy participants, participants with mild, moderate, and severe asthma; and participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).