Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)...
Chronic Obstructive Pulmonary Disease (COPD)This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily [od]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.
Study to Evaluate the Safety and Efficacy of Inhaled PT001 in Patients With Chronic Obstructive...
Chronic Obstructive Pulmonary DiseaseThe purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary disease (COPD).
The Effects of Tiotropium on the Cough Reflex in Patients With Chronic Obstructive Pulmonary Disease...
Chronic Obstructive Pulmonary DiseaseChronic BronchitisDoes tiotropium effect the cough reflex in patients with COPD and chronic bronchitis.
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)...
Chronic Obstructive Pulmonary Disease (COPD)This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.
Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders
COPDCystic Fibrosis2 moreThe purpose of this study is to test the efficacy of Hyperpolarized Helium-3 gas in MR imaging in COPD, asthmatics, CF and healthy volunteers.
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary...
Chronic Obstructive Pulmonary DiseaseThis study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.
Unsupported Arm Exercise and Breathing Strategy in Patients With Chronic Obstructive Pulmonary Disease...
Chronic Obstructive Pulmonary DiseaseControlling the way people with lung problems breathe during arm exercises may reduce their breathlessness during activities of daily living that require them to lift their arms (i.e. brushing their hair, putting groceries away on high shelves). The main aim of this study is to determine the effects of specific breathing strategies during arm exercise on dyspnoea in patients with chronic lung disease. Coordinating inspiration with the action of arm elevation will reduce dyspnoea during a rhythmic overhead arm activity
Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung...
SclerodermaInterstitial Lung DiseaseScleroderma is a rare, long-term autoimmune disease in which normal tissue is replaced with dense, thick fibrous tissue. Normally, the immune system helps defend the body against disease and infection. In people with scleroderma, the immune system triggers fibroblast cells to produce too much of the protein collagen. The extra collagen becomes deposited in the skin and organs, causing hardening and thickening that is similar to the scarring process. Although scleroderma most often affects the skin, it also can affect other parts of the body, including the lungs, and in its most severe forms scleroderma can be life-threatening. Scleroderma-related interstitial lung disease is one example of a life-threatening scleroderma condition. In people with symptomatic scleroderma-related interstitial lung disease, scarring occurs in the delicate lung tissue, compromising lung function. The purpose of this study is to determine whether people with symptomatic scleroderma-related interstitial lung disease experience more respiratory benefits from treatment with a 2-year course of mycophenolate mofetil or treatment with a 1-year course of oral cyclophosphamide.
Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive...
Chronic Obstructive Pulmonary DiseaseThe purpose of this study is to evaluate the safety and efficacy of inhaled PT005 compared to placebo and Formoterol Fumarate (Foradil Aerolizer) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Long-term Safety Study for GSK573719/GW642444 in Japanese
Pulmonary DiseaseChronic ObstructiveThe 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.