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Pulmonary Eosinophilia clinical trials

View clinical trials related to Pulmonary Eosinophilia.

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NCT ID: NCT02555371 Completed - Asthma Clinical Trials

Cessation Versus Continuation of Long-term Mepolizumab in Severe Eosinophilic Asthma Patients

Start date: January 7, 2016
Phase: Phase 3
Study type: Interventional

Primary objective of the study is to evaluate whether patients with severe eosinophilic asthma who have received long-term treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit. Subjects who participated in the open-label studies MEA115666 or 201312 with at least 6 months of treatment with mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed doses of mepolizumab treatment will be eligible to participate in this study. This study will be conducted in 4 parts in approximately 300 subjects. Part A will be Variable Open-Label Run-in (for subjects with less than 3 years of mepolizumab treatment). Once the required 3 year exposure is reached, subjects will enter Part B- Fixed Open-Label Run-In (4 weeks to 8 weeks). During Part A and B subjects will be administered Open-label mepolizumab (100 milligram [mg] Subcutaneous [SC]) every 4 weeks. Part C will be the randomized double-blinded part. Upon completion of Part B, eligible subjects will be randomized to mepolizumab (100 mg SC) every 4 weeks or placebo administered SC every 4 weeks for 52 weeks. Subjects discontinuing investigational product (IP) due to a clinically significant asthma exacerbation will then enter optional Part D of the study. During Part D, subjects receive open-label mepolizumab in addition to their standard of care therapy for the remainder of the study, through Part D up to 52-weeks post-randomization. An Exit Visit will be conducted 52 weeks after randomization in order to assess subject's efficacy parameters, immunogenicity status, and to conduct additional safety assessments. Eligible subjects will participate in the study ranging from 56 to192 weeks, depending on the duration of Part A (0 to 132 weeks) and Part B (4 to 8 weeks).

NCT ID: NCT02281318 Completed - Asthma Clinical Trials

Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma Control

Start date: December 11, 2014
Phase: Phase 3
Study type: Interventional

This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control. The overall intent of the current study is to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL) and other measures of asthma control, including lung function. Participants who meet the predefined criteria will be randomised to receive either mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780 participants with severe eosinophilic asthma will be screened to ensure the randomisation of 544 participants (272 participants per treatment group) into the study.

NCT ID: NCT01508936 Completed - Eosinophilic Asthma Clinical Trials

Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma

Start date: January 2012
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1).

NCT ID: NCT01412736 Completed - Clinical trials for Uncontrolled and Suspected Eosinophilic Asthma

A Phase IIa Study of KHK4563

4563-003
Start date: August 2011
Phase: Phase 2
Study type: Interventional

This is a double-blind, placebo-controlled dose-ranging study of KHK4563 to evaluate the effect of multiple-dose subcutaneous administration of KHK4563 on the annual asthma exacerbation rate in adult subjects with uncontrolled, suspected eosinophilic asthma.

NCT ID: NCT01312961 Completed - Asthma Clinical Trials

Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

Start date: March 2011
Phase: Phase 2
Study type: Interventional

Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma. Secondary Objectives: - To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma. - To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.

NCT ID: NCT01290887 Terminated - Eosinophilic Asthma Clinical Trials

Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.

NCT ID: NCT01287039 Completed - Eosinophilic Asthma Clinical Trials

A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

Start date: April 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in patients with eosinophilic asthma.

NCT ID: NCT01285323 Completed - Eosinophilic Asthma Clinical Trials

A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.

NCT ID: NCT01270464 Completed - Eosinophilic Asthma Clinical Trials

A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma.

NCT ID: NCT01152424 Active, not recruiting - Acute Clinical Trials

Usefulness of Exhaled NO in the Differential Diagnosis Acute Eosinophilic Pneumonia and Bacterial Pneumonia

Start date: July 2010
Phase: N/A
Study type: Observational

Acute eosinophilic pneumonia (AEP) is diagnosed by cell count analysis of bronchoalveolar lavage fluid. However, the performance of bronchoscopy is not easy for patients with AEP, because they usually have hypoxia. Exhaled nitric oxide (FeNO) is usually elevated in the patients with eosinophilic inflammation such as asthma, but there is no previous studies FeNO in the patients with AEP. Investigators hypothesized that FeNO elevated significantly in patients with AEP, and FeNO can be used as non-invasive diagnostic method in patients who are clinically suspected with AEP, especially when the performance of bronchoscopy is difficult.