CLINICAL TRIALS PROFILE FOR DALIRESP

All Clinical Trials for daliresp

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01433666 ↗	Roflumilast and Cognition	Completed	ZonMw: The Netherlands Organisation for Health Research and Development	Phase 2	2011-09-01	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.
NCT01433666 ↗	Roflumilast and Cognition	Completed	Maastricht University Medical Center	Phase 2	2011-09-01	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.
NCT01443845 ↗	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	Completed	AstraZeneca	Phase 4	2011-09-30	To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
NCT01443845 ↗	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	Completed	Forest Laboratories	Phase 4	2011-09-30	To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
NCT01572948 ↗	A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)	Completed	University of Alabama at Birmingham	N/A	2012-06-01	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.
NCT01745848 ↗	Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD	Completed	University of Pittsburgh	Phase 4	2013-02-01	Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease surrogate markers of bone metabolism and early cardiovascular disease in individuals with moderate to severe airflow obstruction and a chronic bronchitis phenotype.
NCT01765192 ↗	Roflumilast Plus Montelukast in Adults With Severe Asthma	Completed	AstraZeneca	Phase 2	2013-02-01	This study will evaluate the effect of roflumilast 500 μg once daily (QD) plus montelukast 10 mg QD versus 10 mg montelukast QD alone on predose (trough) prebronchodilator forced expiratory volume in the first second (FEV1).

Clinical Trial Conditions for daliresp

Condition Name

Condition Name for daliresp
Intervention	Trials
COPD	5
Asthma	3
Chronic Bronchitis	2
Lymphoma, B-Cell	2

Condition MeSH

Condition MeSH for daliresp
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	6
Lung Diseases	5
Lung Diseases, Obstructive	5
Bronchitis, Chronic	3

Clinical Trial Locations for daliresp

Trials by Country

Trials by Country for daliresp
Location	Trials
United States	79
Argentina	5
Canada	5
Mexico	3
Serbia	2

Trials by US State

Trials by US State for daliresp
Location	Trials
Texas	5
California	4
Alabama	4
Pennsylvania	4
Maryland	3

Clinical Trial Progress for daliresp

Clinical Trial Phase

Clinical Trial Phase for daliresp
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 2	3

Clinical Trial Status

Clinical Trial Status for daliresp
Clinical Trial Phase	Trials
Completed	11
Recruiting	3
Not yet recruiting	1

Clinical Trial Sponsors for daliresp

Sponsor Name

Sponsor Name for daliresp
Sponsor	Trials
Forest Laboratories	3
Johns Hopkins University	3
The University of Texas Health Science Center at San Antonio	2

Sponsor Type

Sponsor Type for daliresp
Sponsor	Trials
Other	23
Industry	7
NIH	2