A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI...
Pulmonary DiseaseChronic ObstructiveThe study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD
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.
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)
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).
Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable...
Chronic Obstructive Pulmonary DiseaseThe purpose of this study is to determine whether non-invasive mechanical ventilation(NIV), playing the role as a rescue therapy , are effective in relieving exertional dyspnea in stable severe COPD patients.