Efficacy and Safety of Ba679BR Powder Inhalation in Patients With Chronic Obstructive Pulmonary...
Pulmonary DiseaseChronic ObstructiveStudy to investigate the efficacy and safety of Ba679BR powder inhalation during the continuous once/day administration to the patients with COPD using oxitropium bromide (Tersigan® aerosol) as the comparator drug.
Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard...
Chronic Obstructive Pulmonary Disease (COPD)The purpose of this study is to evaluate discontinuation rates of roflumilast using an up-titration regimen for the first 4 weeks of treatment compared with continuous treatment of 500 μg one daily (OD) during the entire 12-week main period, and to evaluate if participants who do not tolerate roflumilast 500 μg OD have a drug exposure with 250 μg roflumilast OD similar to that observed in other participants with the 500 μg OD dose.
Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo...
Pulmonary DiseaseChronic ObstructiveTo compare the long -term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo in patients with COPD. A secondary objective of this study was to compare the impact of tiotropium and salmeterol on humanistic and economic health outcomes, such as quality of life, patient preference and Health Resource Utilisation in this patient population.
12-week Treatment With Inhaled Tiotropium (18 mcg Once Daily) on Lung Function and Static Lung Volumes...
Pulmonary DiseaseChronic ObstructiveDetermine the effect of 12-week treatment with inhaled tiotropium bromide on lung function and static lung volumes, correlate this effect with dyspnoea in COPD patients.
Comparison of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (MDI) in a Efficacy...
Pulmonary DiseaseChronic ObstructiveThe objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsule (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)
Evaluation of the Lung Deposition Rate and Distribution Pattern of Tiotropium Via HandiHalerTM in...
Pulmonary DiseaseChronic ObstructivePrimary endpoint: whole lung deposition and in-vivo distribution pattern of a 99mTc-labelled tiotropium powder formulation following inhalation via HandiHalerTM in healthy subjects as well as in patients with mild, moderate and severe COPD Secondary endpoints: pharmacokinetics, pharmacodynamics (effect on lung function), safety and tolerability
Efficacy and Safety of Tiotropium and Atrovent in Subjects With Chronic Obstructive Pulmonary Disease...
Pulmonary DiseaseChronic ObstructiveTo compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 µg once daily) and Atrovent® MDI (2 puffs of 20µg q.i.d.) among Filipino patients with COPD
Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in...
COPDChronic Obstructive Pulmonary Disease1 moreThe Objectives of this study are to assess the safety of Aclidinium bromide on major adverse cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Safety, Tolerability and Pharmacokinetics (PK) of RV1162 in Healthy Subjects and COPD Patients
Chronic Obstructive Pulmonary Disease (COPD)Healthy VolunteersRV1162 is a new medicine being developed for possible treatment of smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single and repeat doses of RV1162.
Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With...
Chronic Obstructive Pulmonary Disease (COPD)This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).