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Daliresp Medical Research Studies

Up-to-date List of Daliresp Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Daliresp Medical Research Studies

Rank Status Study
1 Not yet recruiting Strategy to Improve Adherence of Roflumilast
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Roflumilast escalation dosage;   Drug: Roflumilast conventional dosage
Outcome Measures: medication(Roflumilas) history taking;   Laboratory test : Hematology, Biochemistry, and Urinalysis;   Urine pregnancy test;   Chest X-ray Test;   ECG Test;   Lung Function Test;   QoL Questionnaire (CAT score);   Other tests (HBsAg, HCV, HIV)
2 Recruiting A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
Interventions: Drug: roflumilast;   Drug: placebo
Outcome Measures: Change in mean induced sputum proline-glycine-proline (PGP) levels at 3 months after randomization.;   Induced sputum neutrophil counts
3 Recruiting Roflumilast Plus Antipsychotics Proof of Mechanism Study in Schizophrenia
Condition: Schizophrenia
Interventions: Drug: Roflumilast;   Drug: Placebo;   Drug: Second generation antipsychotic
Outcome Measures: Change from Baseline in Spatial Span Test Score;   Change from Baseline in Hopkins Verbal Learning Test Score;   Dorsolateral Prefrontal Cortex Activation During the Rewarded Delayed Response Working Memory Task Compared to the Inter-Trial-Interval as Measured by Functional MRI Blood-Oxygen-Level-Dependent (BOLD) Signal Imaging;   Change from Baseline in the Continuous Performance Test Mean D-Prime Value for the 2-Digit, 3-Digit, and 4-Digit Trials;   Change from Baseline in Brief Assessment of Cognition in Schizophrenia: Symbol-Coding;   Change from Baseline in Category Fluency Test;   Dorsolateral prefrontal cortex activation during the Rewarded Delayed Response Working Memory Task;   Ventro-lateral prefrontal cortex and orbitofrontal cortex activation during the shift trials versus the control trials;   Ventral striatum activation during the reward trials versus the control trials;   Multivariate pattern recognition analysis in the whole brain;   P300 amplitude at the midline parietal electrode (Pz);   Mis Match Negativity (MMN) amplitude at the midline frontal electrode (Fz);   Amplitude of the C1 component of the Visual Evoked Potentials at the midline occipital electrode (Oz);   Beta/gamma power during resting EEG;   Frontal theta power (EEG) in an N-back Working Memory Task;   Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score;   Percentage of participants who experience at least 1 treatment emergent adverse event;   Percentage of participants who meet the markedly abnormal criteria for safety laboratory tests;   Percentage of participants who meet the markedly abnormal criteria for vital sign measurements
4 Recruiting Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis
Condition: Nonalcoholic Steatohapatitis
Interventions: Drug: Roflumilast;   Drug: Pioglitazone;   Drug: Placebo
Outcome Measures: Percent Change from Baseline in Serum Alanine Transaminase (ALT);   Percent Change from Baseline in Serum Aspartate Transaminase (AST);   Change from Baseline in Liver Fat Content at 4 Months
5 Recruiting Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)
Condition: Sarcoidosis
Interventions: Drug: Roflumilast;   Drug: Placebo
Outcome Measures: Reduction in number of episodes of acute exacerbation;   Change in FVC;   Changes in quality of life
6 Recruiting Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
Conditions: COPD;   COPD Exacerbation;   Lung Diseases;   Respiratory Disorders;   Pulmonary Disease;   Chronic Obstructive Lung Diseases;   Chronic Obstructive Airway Disease
Interventions: Drug: Roflumilast;   Drug: Placebo
Outcome Measures: Rate of moderate or severe COPD exacerbations per subject per year;   Prebronchodilator Forced Expiratory Volume in 1 second (FEV1) in Liters
7 Recruiting Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD
Condition: COPD
Interventions: Drug: roflumilast;   Drug: placebo
Outcome Measures: Change from baseline on airway blood flow (Qaw) after single dose of roflumilast .;   Change from baseline on albuterol-induced vasodilation in the airway (delta Qaw) after a single dose of roflumilast.;   Change from baseline on albuterol-inducted vasodilation on the airway after a 4-week treatment of roflumilast.
8 Recruiting Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease and Allied Conditions
Interventions: Drug: Roflumilast;   Drug: Placebo
Outcome Measures: carotid femoral-Pulse Wave Velocity;   Reactive Hyperemia Index;   Augmentation Index
9 Recruiting Roflumilast Safety Administered Once a Day on Alternate Days for Two Weeks Compared to the Usual Dosage Once Daily
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Roflumilast alternated days;   Drug: Roflumilast 500 mcg per day
Outcome Measures: Difference of Adverse Events;   Patients who leave the study
10 Recruiting Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)
Condition: Advanced B-cell Lymphoid Malignancies
Interventions: Drug: Prednisone;   Drug: Roflumilast
Outcome Measures: Safety which will be evaluated by the incidence, severity, relationship and type of adverse events.;   Efficacy which will be measured as any objective response to treatment with roflumilast and prednisone using the descriptions of response provided by the investigator using the response assessment criteria that are appropriate for the patients disease.
11 Not yet recruiting Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization
Condition: COPD
Interventions: Drug: Roflumilast;   Drug: Placebo
Outcome Measures: time to all-cause mortality or re-hospitalization during the 180 days post-randomization.;   respiratory death or respiratory re-hospitalization
12 Recruiting Post Marketing Surveillance of Roflumilast in Korea
Condition: Chronic Obstructive Pulmonary Disease
Intervention: Drug: Roflumilast
Outcome Measures: Number of participants with adverse events and adverse drug reactions;   Effectiveness of treatment;   Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1)
13 Not yet recruiting Effects of Roflumilast on Insulin and Blood Sugar Levels in Prediabetic Overweight and Obese Individuals
Condition: Obesity
Interventions: Drug: Roflumilast;   Drug: Placebo
Outcome Measures: The primary outcome in this study is changes in insulin sensitivity as measured by the stable isotope0-labeled tracer technique and FSIVGTT.;   The secondary outcomes are changed in beta-cell function, postprandial plasma incretin concentrations, circulating levels of adipokines, cytokines, and inflammatory markers, and alterrations in total body fat and lean body mass.
14 Unknown  Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Roflumilast on Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Roflumilast 500;   Drug: Placebo
Outcome Measures: Endotelial function;   Arterial siffness;   Serum and plasma inflammation markers: (CRP, fibrinogen, leucocytes, interleukin (IL)-8, IL-6, IL-10, tumor necrosis factor alpha (TNFα), sICAM-1, MCP-1, PARC/CCL-18);   Serum oxidatrive stress markers: MPO, TRX;   Serum endothelial dysfunction markers:TWEAKs, FasL, ADMA
15 Recruiting Impact of Roflumilast on Visceral Adiposity and Metabolic Profile in Chronic Obstructive Pulmonary Disease
Conditions: Chronic Obstructive Pulmonary Disease;   Metabolic Syndrome
Interventions: Drug: Roflumilast;   Drug: Placebo
Outcome Measures: Change in intrabdominal adiposity;   Change in body mass index;   Change in waist circumference;   Change in waist-to-hip circumference ratio;   Change in blood metabolic profile;   Change in body composition;   Change in subcutaneous adiposity;   Change in liver fat
16 Recruiting Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
Interventions: Drug: Roflumilast;   Drug: Placebo
Outcome Measures: Change in sputum neutrophil counts [cells/g sputum] from Day 1 to Day 14 post exacerbation;   Change in sputum inflammatory markers;   Change in blood biomarkers;   Change in pulmonary function;   Diary outcomes;   Patient-reported outcomes;   Change from Baseline in aortic pulse wave velocity in a subset of participants
17 Recruiting Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
Conditions: COPD;   Chronic Obstructive Pulmonary Disease
Interventions: Drug: Roflumilast;   Drug: Placebo
Outcome Measures: The primary endpoint will be the number of inflammatory cells CD8+ in bronchial biopsy tissue specimen (sub-mucosa) measured at randomization visit V2 and at the end of the intervention period (V6).;   Additional cell count in biopsied material (sub-mucosa and epithelium) [cells/mm2];   Total and differential cell counts in induced sputum;   Concentration of inflammatory biomarkers in sputum;   Concentration of inflammatory biomarkers in blood serum;   Pulmonary function changes in the course of the trial
18 Recruiting Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
Condition: Chronic Obstructive Pulmonary Disease
Intervention: Drug: Roflumilast
Outcome Measures: systemic markers of bone metabolism;   endothelial function
19 Recruiting Patient Registry of Roflumilast In Real Life
Condition: Chronic Obstructive Pulmonary Disease
Intervention:
Outcome Measures: Number of observed exacerbations;   Severity of exacerbations;   Seasonal variation of exacerbation;   Number of hospitalizations due to COPD exacerbations;   Change from Baseline in lung function parameters (FEV1 and FEV1/FVC);   Change from Baseline in blood oxygen saturation;   Percentage of compliance to treatment;   Changes in concomitant administration of COPD maintenance treatments;   Health status using the COPD Assessment Questionnaire (CAT);   Change from Baseline in breathlessness;   Number of Participants with adverse Drug Reactions (ADRs)
20 Unknown  Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients
Condition: Symptomatic Bronchiectasis
Intervention: Drug: Roflumilast
Outcome Measures: change of CASA-Q score;   change of FEV1;   change of FVC;   alanine transaminase

These studies may lead to new treatments and are adding insight into Daliresp etiology and treatment.

A major focus of Daliresp research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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