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Daliresp (Roflumilast) - Summary



The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors.

DALIRESP is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Limitations of Use

DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

See all Daliresp indications & dosage >>


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

Efficacy and safety of roflumilast in patients with stable chronic obstructive pulmonary disease: a meta-analysis. [2014]
AIM: To assess the efficacy and safety of roflumilast in COPD patients... CONCLUSIONS: Roflumilast significantly reduces the mean exacerbation rate in COPD

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

more studies >>

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.

more trials >>

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 >>

Page last updated: 2014-11-30

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