Active clinical trials for "Lung Diseases"

The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.

This is a 24-week, phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The study will have 9 scheduled visits and a telephone contact Follow-up visit one week following the end of study treatment. The study primary endpoint is -Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169 Trough FEV1 on Treatment Day 169 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 168 (i.e. at the Week 24 visit). Secondary endpoints are; Mean TDI focal score at Week 24 Weighted mean clinic visit FEV1 over 0 to 6 hours post-dose at Visit 2 (Day 1) Eligible subjects will be randomised to GSK573719/GW642444 125/25mcg, GSK573719/GW642444 62.5/25mcg and placebo treatment groups in a 1:1:1 ratio such that of the planned 573 total number of randomised subjects, approximately 191 subjects will be randomised to each active treatment group and 191 subjects will be randomised to placebo. All treatments will be administered once daily in the morning by inhalation using a Novel Dry Powder Inhaler (NDPI). There will be a total of 9 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit.1) will complete a 7 to 14 day Run-In period followed by a 24-week Treatment period. Clinic visits will be at screening, Randomisation (Day1), Day2, after 4, 8, 12, 16, and 24-weeks of treatment, and 1 day after the Week 24 Visit (also referred as Treatment Day 169). A Follow-Up contact for adverse event assessment will be conducted by telephone approximately 7 days after Visit 9 or the Early Withdrawal Visit. The total duration of subject participation, including Follow-up will be approximately 27 weeks. All subjects will be provided with albuterol/salbutamol for use on an "as-needed" basis throughout the Run-In and Study Treatment Periods. At screening, pre-bronchodilator spirometry will be performed followed by post-albuterol/salbutamol spirometry testing. Post-albuterol/salbutamol FEV1 and FEV1/FVC values will be used to determine subject eligibility. To further characterise bronchodilator responsiveness, post ipratropium testing will be conducted following completion of post-albuterol/salbutamol spirometry. Spirometry will be conducted at each post-randomisation clinic visit. Six hour post-dose serial spirometry will be conducted at Visit 2. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 9. Assessments of dyspnea will be obtained using the Baseline and Transition Dyspnoea Index (BDI/TDI) which is an interviewer based instrument. At Visit 2, the severity of dyspnoea at baseline will be assessed using the BDI. At subsequent visits (Visits 4, 6, and 8) change from baseline will be assessed using the TDI. Administration of the BDI and TDI should be done prior to spirometry and any other study-related procedures Disease specific health status will be evaluated using the St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT), at baseline (Visit 2) and Visits 4, 6 and 8. The occurrence of adverse events will be evaluated throughout the study beginning at Visit 2. SAEs will be collected over the same time period as for AEs. However, any SAEs assessed as related to study participation (e.g., study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK concomitant medication, will be recorded from the time a subject consents to participate in the study up to and including any follow up contact. Vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory tests (hematology and blood biochemistry) will be obtained at selected clinic visits. For determination of subject disposition, subjects will be considered to have completed the study, upon completion of Visit 9. There is no plan to provide any of the active study treatments for compassionate use following study completion. The Intent-to-Treat (ITT) population will be the primary population of interest, and is defined as all randomised subjects who have received at least one dose of the randomised study medication during the Treatment Period. Supplementary study conduct information not mandated to be present in this protocol is provided in the accompanying Study Procedures Manual (SPM). The SPM will provide the site personnel with administrative and detailed technical information that does not impact subject safety.

Chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and mortality in COPD. Early changes of vascular integrity can be detected via markers of subclinical atherosclerosis. Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data. The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of systemic inflammation in the peripheral circulation of patients with stable chronic obstructive pulmonary disease.

The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Japanese patients with COPD.

The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.

A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.

The purpose of this study is to determine whether the cell therapy with bone marrow mononuclear cells is safe in the treatment of chronic obstructive pulmonary disease, specifically the pulmonary emphysema.

Conventional pulmonary rehabilitation programs improve exercise tolerance, peripheral muscle strength, and health related quality of live but not pulmonary function in patients with chronic obstructive pulmonary disease (COPD). The role of breathing retraining techniques in the rehabilitation of patients with COPD remains unclear. The hypothesis to be tested in this study is that pulmonary function, cardio-pulmonary exercise capacity, health related quality of life and cardiac autonomic modulation of patients with COPD who undergo pulmonary rehabilitation plus breathing retraining will be better than that of patients undergoing a conventional pulmonary rehabilitation.

Pursed-lip breathing (PLB) has been advocated to reduce respiratory rate and improve oxygen saturation in patients with chronic obstructive pulmonary disease (COPD) at rest. Although PLB is a strategy that potentially reduces expiratory flow limitation, there are only few studies addressing its effects on exercise. This study aimed to assess the ability of PLB to change the breathing pattern, degree of dynamic hyperinflation (DH) and arterial oxygenation in COPD patients during exercise. Exercise tolerance was evaluated by endurance time and respiratory mechanics was evaluated by forced oscillation technique.

This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.