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Roflumilast

Clinical trials are investigating Roflumilast in different patient groups, including people with chronic obstructive pulmonary disease (COPD) and chronic hand eczema. These studies look at whether Roflumilast can help, how well it works, and whether it is safe in these conditions.

Table of Contents

Overview of the trials

These clinical trials studied Roflumilast in two different diseases: chronic obstructive pulmonary disease (COPD) and chronic hand eczema.[1][2] Both studies were interventional, which means the researchers gave a treatment and compared results across groups.[1][2] Both trials were completed.[1][2]

COPD Phase 3 study

The COPD trial, NCT04636814, was a Phase 3 study with 3,978 participants.[1] It studied people with COPD who were already on maintenance triple therapy, meaning regular treatment with three medicines used together to control the disease.[1] The study compared two doses of CHF6001 added to standard treatment, and it also included oral Roflumilast 500 micrograms and 250 micrograms as treatment options in the intervention list.[1]

The main goal was to see whether add-on treatment could reduce the number of moderate and severe exacerbations over 52 weeks.[1] An exacerbation is a flare-up, or worsening, of COPD symptoms.[1] This type of outcome helps show whether a treatment can lower the burden of flare-ups over time.[1]

Chronic hand eczema Phase 2 study

The hand eczema trial, 2022-503011-42-00, was a Phase 2 study with 40 adult participants.[2] It studied oral Roflumilast 500 micrograms compared with placebo in people with chronic hand eczema.[2] A placebo is a look-alike treatment with no active study drug, used to help compare results fairly.[2]

The study aimed to find out whether Roflumilast could improve eczema severity and whether it was safe in adults with this skin condition.[2] The trial focused on a specific patient group with long-lasting hand eczema, not on COPD.[2]

Key outcomes measured

In the COPD study, the main outcome was the annual rate of moderate and severe exacerbations over 52 weeks.[1] This means the researchers counted how often patients had flare-ups during one year.[1]

In the hand eczema study, the main outcome was the proportion of patients who reached HECSI75 at week 16.[2] HECSI is a score that measures hand eczema severity by looking at how much skin is affected and how intense the disease is.[2] HECSI75 means the score improved by at least 75% from the start of the study.[2]

What the trials mean for patients

These studies show that Roflumilast has been tested in both a lung disease population and a skin disease population.[1][2] The trial designs were different because the diseases and goals were different.[1][2]

The COPD study was much larger and later-stage, while the chronic hand eczema study was smaller and earlier-stage.[1][2] Together, they help researchers understand whether Roflumilast may be useful in specific patient groups and what outcomes should be measured in future research.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT04636814 Phase 3 Chronic Obstructive Pulmonary Disease (COPD) Completed 3978
2022-503011-42-00 Phase 2 Chronic hand eczema Completed 40

FAQ

  • What conditions are being studied with Roflumilast? The trials in this set study Roflumilast in chronic obstructive pulmonary disease (COPD) and chronic hand eczema. These are different conditions, so the studies focus on different patient groups and outcomes.
  • Who can take part in these trials? One trial enrolled adults with chronic hand eczema. Another trial studied people with COPD who were already on maintenance triple therapy. Each study has its own rules for who can join.
  • What phases are the Roflumilast trials? The COPD study is Phase 3, which usually means a larger trial looking at how well a treatment works in a bigger group. The chronic hand eczema study is Phase 2, which often looks more closely at early signs of benefit and safety.
  • What are the trials measuring? The COPD trial measured the annual rate of moderate and severe exacerbations over 52 weeks. The hand eczema trial measured how many patients reached HECSI75 at week 16, meaning at least a 75% drop in eczema severity score.
  • Are these studies completed? Yes, both trials listed here are completed. That means the planned study period has ended and the results can be analyzed.

Ongoing Clinical Trials on Roflumilast

  • Study on the Effectiveness and Safety of CHF6001 DPI with Roflumilast for Patients with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis

    Not recruiting

    1 1
    Investigated drugs:
    Austria Bulgaria Croatia Czechia Estonia Germany +8

  • Study on Oral Roflumilast for Treating Chronic Hand Eczema in Adults

    Not recruiting

    1 1
    Investigated drugs:
    Denmark

Glossary

  • Clinical trial: A planned research study in people that tests whether a treatment works and is safe.
  • Phase 2: An earlier stage of testing that looks for signs that a treatment may help and checks safety in a smaller group.
  • Phase 3: A later stage of testing in a larger group to better understand how well a treatment works.
  • Chronic obstructive pulmonary disease (COPD): A long-term lung disease that makes it hard to breathe.
  • Chronic hand eczema: A long-lasting skin condition that causes inflammation, irritation, and rash on the hands.
  • Maintenance triple therapy: A regular treatment plan that uses three medicines together to help control COPD.
  • Exacerbation: A flare-up or worsening of symptoms.
  • HECSI: A score that measures how severe hand eczema is by looking at how much skin is affected and how intense the symptoms are.
  • HECSI75: A study goal meaning the HECSI score improved by at least 75% compared with the start of the trial.
  • Placebo: A look-alike treatment with no active study drug, used for comparison.

References