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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: roflumilast Clear all
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, 7:45 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, 7:45 AM EDT
Not listed Phase 4 Interventional Accepts healthy volunteers

Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin

NCT06440473
View directory record Official record
Conditions
Healthy Skin
Interventions
Roflumilast, Vehicle (Roflumilast 0.3% vehicle cream)
Drug · Other
Lead sponsor
Rao Dermatology
Other
Eligibility
18 Years and older
Enrollment
3 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
1
States / cities
Atlantic Highlands, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 2, 2024 · Synced Sep 23, 2026, 7:45 AM EDT
Completed Early Phase 1 Interventional Results available

Phase 0/1 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies (CTRC# 13-0013)

NCT01888952
View directory record Official record
Conditions
Advanced B-cell Lymphoid Malignancies
Interventions
Prednisone, Roflumilast
Drug
Lead sponsor
Anand B. Karnad
Other
Eligibility
18 Years to 100 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Feb 26, 2017 · Synced Sep 23, 2026, 7:45 AM EDT
Completed Phase 2 Interventional Results available

The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

NCT03638258
View directory record Official record
Conditions
Plaque Psoriasis
Interventions
Roflumilast Cream 0.3%, Roflumilast Cream 0.15%, Vehicle Cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
331 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
20
States / cities
Beverly Hills, California • Northridge, California • San Diego, California + 16 more
Source: ClinicalTrials.gov public record
Updated Sep 1, 2022 · Synced Sep 23, 2026, 7:45 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, 7:45 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, 7:45 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, 7:45 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, 7:45 AM EDT
Completed Phase 3 Interventional Results available

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

NCT04773600
View directory record Official record
Conditions
Atopic Dermatitis Eczema
Interventions
Roflumilast Cream, Vehicle cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
6 Years and older
Enrollment
683 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
44
States / cities
Birmingham, Alabama • Fort Smith, Arkansas • Inglewood, California + 38 more
Source: ClinicalTrials.gov public record
Updated Oct 3, 2024 · Synced Sep 23, 2026, 7:45 AM EDT
Completed Phase 3 Interventional Results available

Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

NCT04804605
View directory record Official record
Conditions
Atopic Dermatitis Eczema
Interventions
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
2 Years and older
Enrollment
1,220 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
76
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Bryant, Arkansas + 64 more
Source: ClinicalTrials.gov public record
Updated Dec 22, 2025 · Synced Sep 23, 2026, 7:45 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, 7:45 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers

Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea

NCT05278624
View directory record Official record
Conditions
Rosacea
Interventions
Roflumilast Cream
Drug
Lead sponsor
Dermatology Consulting Services, PLLC
Network
Eligibility
18 Years to 70 Years
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
1
States / cities
High Point, North Carolina
Source: ClinicalTrials.gov public record
Updated May 30, 2023 · Synced Sep 23, 2026, 7:45 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, 7:45 AM EDT
Not yet recruiting Phase 4 Interventional

An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis

NCT07725822
View directory record Official record
Conditions
Chronic Plaque Psoriasis, Nail Psoriasis
Interventions
Roflumilast 0.3% topical cream
Drug
Lead sponsor
Modern Research Associates, PLLC
Other
Eligibility
Not listed
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Sep 23, 2026, 7:45 AM EDT
Completed Phase 4 Interventional Results available

Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

NCT01745848
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Roflumilast
Drug
Lead sponsor
University of Pittsburgh
Other
Eligibility
50 Years to 75 Years
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Aug 28, 2017 · Synced Sep 23, 2026, 7:45 AM EDT
Completed Phase 3 Interventional Results available

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

NCT04211363
View directory record Official record
Conditions
Chronic Plaque Psoriasis
Interventions
Roflumilast 0.3% cream, Vehicle Cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
2 Years and older
Enrollment
439 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
31
States / cities
Encinitas, California • Fremont, California • Irvine, California + 26 more
Source: ClinicalTrials.gov public record
Updated Dec 6, 2022 · Synced Sep 23, 2026, 7:45 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, 7:45 AM EDT
Recruiting Phase 2 Interventional

The Safety and Efficacy of Roflumilast Foam in HS

NCT07263230
View directory record Official record
Conditions
Hidradenitis Suppurativa (HS)
Interventions
Roflumilast 0.3% topical foam
Drug
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 8, 2026 · Synced Sep 23, 2026, 7:45 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, 7:45 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, 7:45 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, 7:45 AM EDT
Completed Phase 3 Interventional Results available

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

NCT04845620
View directory record Official record
Conditions
Atopic Dermatitis Eczema
Interventions
Roflumilast Cream 0.05%, Vehicle Cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
2 Years to 5 Years
Enrollment
652 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
71
States / cities
Birmingham, Alabama • Montgomery, Alabama • Gilbert, Arizona + 60 more
Source: ClinicalTrials.gov public record
Updated Dec 22, 2025 · Synced Sep 23, 2026, 7:45 AM EDT
Completed Phase 1 Interventional

Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma

NCT03458546
View directory record Official record
Conditions
Lymphoma, B-Cell
Interventions
Roflumilast
Drug
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Eligibility
18 Years and older
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Feb 20, 2024 · Synced Sep 23, 2026, 7:45 AM EDT