NEWS HIGHLIGHTS
Published Studies Related to Daliresp (Roflumilast)
Roflumilast attenuates pulmonary inflammation upon segmental endotoxin challenge
in healthy subjects: a randomized placebo-controlled trial. [2008]
of roflumilast in a human model of segmental bronchial endotoxin challenge... CONCLUSIONS: Roflumilast attenuated the endotoxin-induced influx of neutrophils
Effect of 1-year treatment with roflumilast in severe chronic obstructive
pulmonary disease. [2007]
exacerbation frequency over 1 year in patients with stable COPD... CONCLUSIONS: In severe, stable COPD, PDE4 inhibition with roflumilast produced a
Roflumilast, a phosphodiesterase 4 inhibitor, reduces airway hyperresponsiveness
after allergen challenge. [2007]
asthmatic response to allergen challenge... CONCLUSIONS: Roflumilast attenuated allergen-induced AHR in patients with mild
High absolute bioavailability of the new oral phosphodiesterase-4 inhibitor
roflumilast. [2011]
to determine the absolute bioavailability of ROF in humans... CONCLUSION: ROF is rapidly absorbed after PO administration and exhibits high
Roflumilast: first phosphodiesterase 4 inhibitor approved for treatment of COPD. [2010]
In April 2010, the European Medicines Agency Committee for Medicinal Products for
Human Use recommended approval of roflumilast, a selective phosphodiesterase 4
inhibitor, for the "maintenance treatment of severe chronic obstructive pulmonary
disease (COPD, FEV(1) postbronchodilator less than 50% predicted) associated with
chronic bronchitis in adult patients with a history of frequent exacerbations as
add-on to bronchodilator treatment"...
Clinical Trials Related to Daliresp (Roflumilast)
Roflumilast Plus Montelukast in Adults With Severe Asthma [Not yet recruiting]
The purpose of this study is to evaluate the effect of roflumilast alone and in combination
with montelukast on forced expiratory volume in 1 second (FEV1) in patients with
inadequately controlled asthma.
A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD) [Not yet recruiting]
The purpose of the study is to propose that roflumilast is associated with meaningful
reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including
confirmation of previously described results, and correlate these findings with improvement
in pulmonary function, sputum scores, and quality of life in stable moderate to severe COPD.
The investigators aim to demonstrate this regardless of concomitant medication use,
including inhaled corticosteroids. Additionally, the investigators hope to provide a
mechanistic pathway by which these effects occur.
Roflumilast and Cognition [Recruiting]
The aim of the current project is to validate PDE4 inhibitors as a target for cognition
enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will
demonstrate whether memory, but also attention, information processing or executive function
improves with the PDE4 inhibitor roflumilast in healthy humans.
Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis [Not yet recruiting]
The purpose of this study is to evaluate the effect of roflumilast and pioglitazone therapy
on serum transaminase (ALT) levels in adults with Nonalcoholic SteatoHepatitis.
Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD) [Recruiting]
Chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory
process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and
mortality in COPD. Early changes of vascular integrity can be detected via markers of
subclinical atherosclerosis.
Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option
in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an
anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data.
The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor
Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of
systemic inflammation in the peripheral circulation of patients with stable chronic
obstructive pulmonary disease.
Reports of Suspected Daliresp (Roflumilast) Side Effects
Diarrhoea (46),
Nausea (42),
Decreased Appetite (37),
Insomnia (37),
Weight Decreased (33),
Headache (27),
Dyspnoea (27),
Dizziness (25),
Tremor (23),
Anxiety (22), more >>
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