This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation.
This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen.
The purpose of this study is to evaluate the long-term safety, efficacy and tolerability of dupilumab in patients with asthma who participated in a previous dupilumab asthma study.
This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2015) in each of the groups (patients with severe asthma and high eosinophil counts and all patients with severe asthma).
The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid.
The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066 as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066.
The purpose of this study is to evaluate specific alterations in immune cell mechanisms related to neutrophil function as detected by PI3Kdelta-dependent changes in messenger ribonucleic acid (mRNA) extracted from induced sputum in patients experiencing an exacerbation of COPD, with or without treatment with GSK2269557. The efficacy of treatment with GSK2269557 will also be measured using functional respiratory imaging (FRI) and spirometry. This is a randomised, double-blind, placebo-controlled, parallel-group study.
Primary Objective:
To evaluate the efficacy of dupilumab (SAR231893 [REGN668]) in patients with persistent asthma.
Secondary Objectives:
To evaluate the safety and tolerability of dupilumab. To evaluate the effect of dupilumab in improving patient-reported outcomes including health-related quality of life.
To evaluate dupilumab systemic exposure and incidence of antidrug antibodies.
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD
Prospective, single-arm, longitudinal, international, multicentre study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.
The disease being studied is asthma. The main objective of this study is to assess the feasibility of the recruitment goals and also the logistical issues related to use of tele-health technology in developing electronic asthma action plan (eAAP) and communicate with asthma patients in a time period of 24 months. The goals are: 1) enable asthma patients to self-manage their asthma symptoms. The secondary, 2) help care providers to intervene appropriately based on the patient's health status.