Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Roflumilast

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    38 result(s) found for: Roflumilast. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2013-001788-21 Sponsor Protocol Number: RO-2455-302-RD Start Date*: 2014-04-11
    Sponsor Name:TAKEDA DEVELOPMENT CENTRE EUROPE LTD
    Full Title: A multicenter, randomized, double-blind phase 3 study to evaluate tolerability and pharmacokinetics of 500μg roflumilast once daily with an up-titration regimen in COPD, including an open-label do...
    Medical condition: chronic obstructive pulmonary disease (COPD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SK (Completed) DE (Completed) HU (Completed) RO (Completed) GR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2020-003768-16 Sponsor Protocol Number: DR-2019-00310 Start Date*: 2021-05-04
    Sponsor Name:Hersenstichting
    Full Title: A proof of concept phase II study with the PDE4 inhibitor roflumilast in people suffering from long-term cognitive sequela after stroke
    Medical condition: Cerebrovascular accident
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004959-36 Sponsor Protocol Number: 446002504 Start Date*: 2020-09-30
    Sponsor Name:ZonMw
    Full Title: A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment (MCI).
    Medical condition: Mild Cognitive Impairment (MCI)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002070-23 Sponsor Protocol Number: EEGrofl Start Date*: 2011-10-12
    Sponsor Name:Maastricht University Medical Center
    Full Title: Effects of roflumilast on cognition in healthy adults: a behaviour-EEG study
    Medical condition: None; this proof-of-principle study will examine the cognition enhancing effects of roflumilast in healthy subjects
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-002998-62 Sponsor Protocol Number: ROF-PSOR_104 Start Date*: 2012-12-13
    Sponsor Name:Takeda Pharma A/S
    Full Title: A Randomized, Single-Center, Observer-Blind, Vehicle- and Active Comparator-Controlled Phase 1b Study to Assess the Effect and Local Safety and Tolerability Of Roflumilast and BYK321084 – Phosphod...
    Medical condition: Mild to moderate, chronical, stable Psoriasis vulgaris
    Disease: Version SOC Term Classification Code Term Level
    15.1 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-006931-25 Sponsor Protocol Number: N/A Start Date*: 2022-03-24
    Sponsor Name:Bispebjerg and Frederiksberg Hospital, University of Copenhagen
    Full Title: Efficacy and safety of oral roflumilast in the treatment of palmoplantar pustulosis – a randomised controlled trial
    Medical condition: Palmoplantar pustulosis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004858 10037158 Psoriasis palm & soles LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-019685-87 Sponsor Protocol Number: RO-2455-404-RD Start Date*: 2011-04-27
    Sponsor Name:Takeda Pharma A/S
    Full Title: Effect of roflumilast on exacerbation rate in patients with COPD treated with fixed combinations of LABA and ICS. A 52-week, randomised double-blind trial with roflumilast 500 μg versus placebo
    Medical condition: severe chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) DE (Completed) AT (Completed) DK (Completed) GR (Completed) NL (Completed) HU (Completed) SK (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-000711-76 Sponsor Protocol Number: N/A Start Date*: 2020-07-13
    Sponsor Name:Alexander Egeberg
    Full Title: Efficacy of roflumilast in the treatment of psoriasis – a randomised controlled trial
    Medical condition: Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-001065-18 Sponsor Protocol Number: BY217/M2-015 incl. Amendment No1 Start Date*: 2004-10-04
    Sponsor Name:ALTANA Pharma AG
    Full Title: Morning versus evening administration of 500µg Roflumilast once dailyfor 6 weeks in patients with asthma.
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    5.1 10003553 llt
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-003648-97 Sponsor Protocol Number: CLI-06001AA1-05 Start Date*: 2021-05-17
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A 52-week, randomized, double-blind, double-dummy, placebo- and active- controlled (Roflumilast, Daliresp® 500μg), parallel group, study to evaluate the efficacy and safety of two doses of CHF6001 ...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Trial now transitioned) CZ (Trial now transitioned) DE (Trial now transitioned) HU (Trial now transitioned) SK (Trial now transitioned) PL (Trial now transitioned) GR (Trial now transitioned) AT (Trial now transitioned) NL (Trial now transitioned) EE (Trial now transitioned) LV (Trial now transitioned) ES (Ongoing) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-000582-13 Sponsor Protocol Number: RO-2455-402-RD Start Date*: 2012-03-05
    Sponsor Name:Takeda Development Centre Europe Ltd.
    Full Title: A 16-week, randomized, placebo-controlled, double blind, and parallel group trial to assess the anti-inflammatory effects of Roflumilast in chronic obstructive pulmonary disease The ROBERT study ...
    Medical condition: severe chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004855 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) SE (Completed) PL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-006321-20 Sponsor Protocol Number: RO-FLU-2011 Start Date*: 2012-05-29
    Sponsor Name:FUNDACIÓN PROGRESO Y SALUD
    Full Title: “Ensayo clínico, ciego y de grupos paralelos para analizar diferencias en la seguridad de roflumilast administrado una vez al día en días alternos durante dos semanas respecto a la pauta habitual u...
    Medical condition: Enfermedad Pulmonar Obstructiva Crónica (EPOC).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-003037-41 Sponsor Protocol Number: MUG-EROS-2012 Start Date*: 2012-09-21
    Sponsor Name:Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Lungenkrankheiten
    Full Title: Effects of Roflumilast on pulmonary vascular resistance in patients with COPD and sleep apnea (Overlap Syndrome) with and without non-invasive ventilation. A Pilot Study.
    Medical condition: This study is about pulmonary hypertension due to lung diseases. The lung disease in this study will be the overlap syndrome which is defined as chronic obstructive pulmonary disease concomitant wi...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10010952 COPD LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10040976 Sleep apnea syndrome LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-005080-28 Sponsor Protocol Number: BY217/M2-127 Start Date*: 2006-04-04
    Sponsor Name:ALTANA Pharma AG
    Full Title: Effect of roflumilast in COPD patients treated with salmeterol. A 24 week, double blind study with 500 mcg roflumilast once daily versus placebo
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10010952 llt
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) GB (Completed) ES (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-004508-37 Sponsor Protocol Number: BY217/M2-128 Start Date*: 2007-01-08
    Sponsor Name:Nycomed GmbH
    Full Title: Effect of roflumilast in COPD patients treated with tiotropium. A 24-week, double-blind study with 500 µg roflumilast once daily versus placebo.
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) HU (Completed) AT (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-002064-27 Sponsor Protocol Number: ROF-ASTHMA_202 Start Date*: 2013-02-01
    Sponsor Name:Takeda Pharma A/S
    Full Title: A Phase 2, Randomized, Double-blind, 4-week Cross-over Trial to Investigate The Effect of a Once-daily Combination of 500 µg Roflumilast plus 10 mg Montelukast versus 10 mg Montelukast Alone on Pul...
    Medical condition: Pulmonary Function, Asthma Symptoms and Inflammatory Markers in Subjects with Severe Asthma
    Disease: Version SOC Term Classification Code Term Level
    15.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2011-004152-19 Sponsor Protocol Number: ELASTIC2011 Start Date*: 2012-04-18
    Sponsor Name:Ludwig Boltzmann institute for COPD and Respiratory Epidemiology
    Full Title: Effects of ROFLUMILAST on markers of subclinical atherosclerosis In stable COPD; the ELASTIC-trial
    Medical condition: chronic obstructive pulmonary disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-002905-31 Sponsor Protocol Number: RO-2455-405-RD Start Date*: 2011-12-01
    Sponsor Name:Nycomed GmbH
    Full Title: Effect of roflumilast 500 μg tablets once daily at acute COPD exacerbations treated with standard therapy of oral steroids and antibiotics. A randomised, double-blind, placebo-controlled, parallel-...
    Medical condition: Acute exacerbations of chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004855 10010952 COPD LLT
    16.0 100000004855 10010953 COPD exacerbation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002101-29 Sponsor Protocol Number: RO-2499-401-RD Start Date*: 2011-09-22
    Sponsor Name:Nycomed GmbH
    Full Title: A randomised, double-blind, 4-weeks cross-over trial to investigate the effect of 500 µg roflumilast tablets once-daily versus placebo on pulmonary function, asthma symptoms and inflammatory marker...
    Medical condition: severe uncontrolled asthma
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003555 Asthma bronchial LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-003937-42 Sponsor Protocol Number: BY217/M2-124 Start Date*: 2005-06-16
    Sponsor Name:ALTANA Pharma AG
    Full Title: Effect of roflumilast on exacerbation rate in patients with COPD A 52 weeks, double-blind study with 500 mcg roflumilast once daily versus placebo
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10010952 llt
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) HU (Completed) GB (Completed) DE (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 02 01:26:05 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA