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Showing 1–24 of 25 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Roflumilast Placebo Clear all
Completed Phase 1 Interventional

The Role of Phosphodiesterase Inhibitors in Incretin Secretion

NCT02363335
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Placebo, Roflumilast/Sitagliptin, Sitagliptin, Roflumilast
Other
Lead sponsor
National Institute on Aging (NIA)
NIH
Eligibility
21 Years to 55 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 3 Interventional Results available

Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

NCT05763082
View directory record Official record
Conditions
Plaque Psoriasis
Interventions
roflumilast cream 0.3%, Zoryve, Placebo
Drug
Lead sponsor
Padagis LLC
Industry
Eligibility
12 Years to 75 Years
Enrollment
416 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023
U.S. locations
1
States / cities
Louisville, Kentucky
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 3 Interventional Results available

Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

NCT04211389
View directory record Official record
Conditions
Chronic Plaque Psoriasis
Interventions
ARQ-151 0.3% cream, ARQ-151 vehicle cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
2 Years and older
Enrollment
442 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
31
States / cities
Scottsdale, Arizona • Beverly Hills, California • Encino, California + 26 more
Source: ClinicalTrials.gov public record
Updated Dec 6, 2022 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

NCT04091646
View directory record Official record
Conditions
Seborrheic Dermatitis
Interventions
Roflumilast Foam 0.3%, Vehicle foam
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
226 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
22
States / cities
Fremont, California • Santa Monica, California • Coral Gables, Florida + 19 more
Source: ClinicalTrials.gov public record
Updated Jul 2, 2023 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 1 Interventional Results available

Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes

NCT01664624
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
Roflumilast, Alogliptin, Exenatide, Placebo to roflumilast, Placebo to alogliptin
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 80 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012
U.S. locations
2
States / cities
Chula Vista, California • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Jan 31, 2017 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 3 Interventional

Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)

NCT00163527
View directory record Official record
Conditions
Asthma
Interventions
Roflumilast
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
12 Years to 70 Years
Enrollment
2,054 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2005
U.S. locations
1
States / cities
Cities in Georgia, Georgia
Source: ClinicalTrials.gov public record
Updated Dec 1, 2016 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Not applicable Interventional Results available

A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)

NCT01572948
View directory record Official record
Conditions
COPD
Interventions
roflumilast, placebo
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
40 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Oct 18, 2015 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 4 Interventional Results available

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

NCT01443845
View directory record Official record
Conditions
COPD, COPD Exacerbation, Lung Diseases, Respiratory Disorders, Pulmonary Disease, Chronic Obstructive Lung Diseases, Chronic Obstructive Airway Disease
Interventions
Roflumilast, Placebo
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
40 Years and older
Enrollment
2,354 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2016
U.S. locations
217
States / cities
Anniston, Alabama • Athens, Alabama • Florence, Alabama + 175 more
Source: ClinicalTrials.gov public record
Updated Apr 12, 2017 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 3 Interventional Results available

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

NCT00297102
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
Roflumilast, Placebo
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
40 Years and older
Enrollment
1,523 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
47
States / cities
Fullerton, California • Los Angeles, California • Palmdale, California + 43 more
Source: ClinicalTrials.gov public record
Updated Jan 15, 2017 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 3 Interventional Results available

Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization

NCT01973998
View directory record Official record
Conditions
COPD
Interventions
Roflumilast, Placebo
Drug
Lead sponsor
Temple University
Other
Eligibility
40 Years to 80 Years
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Mar 11, 2020 · Synced Sep 23, 2026, 1:24 AM EDT
Recruiting Early Phase 1 Interventional Accepts healthy volunteers

Exercise as an Immune Adjuvant for Allogeneic Cell Therapies

NCT06643221
View directory record Official record
Conditions
Leukemia, Hematopoetic Stem Cell Transplantation, Donor Lymphocyte Infusion, CAR T-Cell Therapy, Lymphoma, Cell Therapy
Interventions
Exercise, Isoproterenol, Placebo, Bisoprolol Fumarate Tablet 10 mg, Nadolol (1 x 80 mg) Tablets (Invamed, Inc), Carvedilol 50 mg, Roflumilast 500 Mcg Oral Tablet
Behavioral · Drug
Lead sponsor
University of Arizona
Other
Eligibility
21 Years to 55 Years
Enrollment
200 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2031
U.S. locations
1
States / cities
Tucson, Arizona
Source: ClinicalTrials.gov public record
Updated Jun 4, 2026 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 3 Interventional Results available

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

NCT00297115
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
Roflumilast, Placebo
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
40 Years and older
Enrollment
1,568 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
151
States / cities
Bayou La Batre, Alabama • Birmingham, Alabama • Huntsville, Alabama + 131 more
Source: ClinicalTrials.gov public record
Updated Nov 6, 2016 · Synced Sep 23, 2026, 1:24 AM EDT
Terminated Phase 3 Interventional

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

NCT04636814
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
CHF6001 1600µg, CHF6001 3200µg, Placebo, Roflumilast
Drug
Lead sponsor
Chiesi Farmaceutici S.p.A.
Industry
Eligibility
40 Years and older
Enrollment
3,973 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
150
States / cities
Andalusia, Alabama • Foley, Alabama • Guntersville, Alabama + 102 more
Source: ClinicalTrials.gov public record
Updated Feb 1, 2026 · Synced Sep 23, 2026, 1:24 AM EDT
Active, not recruiting Phase 2 Interventional

Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

NCT05418049
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Baclofen, Memantine, Roflumilast, Placebo
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
18 Years to 45 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Dec 22, 2025 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 3 Interventional

OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

NCT00076089
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease, COPD
Interventions
Roflumilast
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
40 Years and older
Enrollment
1,100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2005
U.S. locations
35
States / cities
Cities in Alabama, Alabama • Cities in Arizona, Arizona • Cities in Arkansas, Arkansas + 32 more
Source: ClinicalTrials.gov public record
Updated Dec 1, 2016 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 3 Interventional

Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

NCT00073177
View directory record Official record
Conditions
Asthma
Interventions
Roflumilast
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 70 Years
Enrollment
819 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2003
U.S. locations
37
States / cities
Cities in Alabama, Alabama • Cities in Arizona, Arizona • Cities in Arkansas, Arkansas + 34 more
Source: ClinicalTrials.gov public record
Updated Oct 24, 2016 · Synced Sep 23, 2026, 1:24 AM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers

Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma

NCT04108377
View directory record Official record
Conditions
Asthma
Interventions
Roflumilast, Placebo
Drug
Lead sponsor
University of California, Davis
Other
Eligibility
18 Years and older
Enrollment
5 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2023
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Oct 23, 2023 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis

NCT04128007
View directory record Official record
Conditions
Plaque Psoriasis
Interventions
Roflumilast foam 0.3%, Vehicle foam
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
12 Years and older
Enrollment
304 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
31
States / cities
Rogers, Arkansas • Fremont, California • San Diego, California + 27 more
Source: ClinicalTrials.gov public record
Updated Oct 25, 2022 · Synced Sep 23, 2026, 1:24 AM EDT
Not listed Phase 4 Interventional

Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)

NCT01830959
View directory record Official record
Conditions
Sarcoidosis
Interventions
Roflumilast, Placebo
Drug
Lead sponsor
University of Cincinnati
Other
Eligibility
18 Years to 70 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Dec 7, 2015 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 3 Interventional

The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)

NCT00076076
View directory record Official record
Conditions
Asthma
Interventions
Roflumilast
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years and older
Enrollment
822 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2005
U.S. locations
39
States / cities
Cities in Alabama, Alabama • Cities in Arizona, Arizona • Cities in Arkansas, Arkansas + 36 more
Source: ClinicalTrials.gov public record
Updated Dec 1, 2016 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD

NCT02097992
View directory record Official record
Conditions
COPD
Interventions
Roflumilast Placebo, Roflumilast
Drug
Lead sponsor
University of Miami
Other
Eligibility
45 Years and older
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Nov 23, 2017 · Synced Sep 23, 2026, 1:24 AM EDT
Terminated Phase 2 Interventional Results available

Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis

NCT01703260
View directory record Official record
Conditions
Nonalcoholic Steatohapatitis
Interventions
Roflumilast, Pioglitazone, Placebo
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 80 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
4
States / cities
Coronado, California • Annapolis, Maryland • Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jan 31, 2017 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 2 Interventional Results available

Trial of Roflumilast in Asthma Management (TRIM)

NCT03532490
View directory record Official record
Conditions
Asthma, Obesity
Interventions
Roflumilast 500 Mcg Oral Tablet, Placebo oral capsule
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
18 Years and older
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
7
States / cities
Birmingham, Alabama • Tucson, Arizona • Chicago, Illinois + 3 more
Source: ClinicalTrials.gov public record
Updated Oct 5, 2022 · Synced Sep 23, 2026, 1:24 AM EDT
Completed Phase 3 Interventional

Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

NCT00062582
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease, COPD
Interventions
Roflumilast
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years and older
Enrollment
1,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2003
U.S. locations
32
States / cities
Cities in Alabama, Alabama • Cities in Arizona, Arizona • Cities in California, California + 29 more
Source: ClinicalTrials.gov public record
Updated Nov 22, 2016 · Synced Sep 23, 2026, 1:24 AM EDT