Europas førende søgning efter kliniske forsøg

Roflumilast

Clinical trials are investigating Roflumilast in people with chronic obstructive pulmonary disease (COPD) and chronic hand eczema. These studies look at how well it works, how safe it is, and which patients may benefit most. The trials include adults in different phases of research, from phase 2 to phase 3.

Table of contents

Overview of the trials

The source data includes two interventional studies of Roflumilast, one in people with chronic obstructive pulmonary disease (COPD) and one in adults with chronic hand eczema.[1][2] Both studies are marked as completed.[1][2]

These trials are not general drug descriptions; they are research studies that ask whether Roflumilast may help in specific patient groups and what results can be measured over time.[1][2]

COPD trial: add-on treatment in maintenance therapy

The COPD study, NCT04636814, tested two doses of CHF6001 as an add-on to maintenance triple therapy in people with COPD.[1] The trial also included Roflumilast 500 micrograms and Roflumilast 250 micrograms as oral treatment options, with matching placebo groups for comparison.[1]

This was a phase 3 study with 3,978 participants.[1] The main goal was to see whether treatment could lower the annual rate of moderate and severe exacerbations over 52 weeks.[1] In simple words, the study looked at whether patients had fewer serious worsening episodes during one year of treatment.[1]

The study population was people with COPD who were already receiving maintenance triple therapy, which in the source is described as free or fixed combination of ICS, LABA, and LAMA.[1] This means the trial focused on patients who were already on regular COPD treatment, not on untreated patients.[1]

Chronic hand eczema trial

The second study, called HERO, tested oral Roflumilast in adults with chronic hand eczema.[2] It compared Roflumilast 500 micrograms with placebo.[2]

This was a phase 2 trial with 40 participants.[2] The purpose was to investigate both efficacy and safety in this skin condition.[2] Because it was a smaller phase 2 study, it was designed to get early information on whether the treatment may help adults with chronic hand eczema.[2]

The main outcome was the proportion of patients who achieved at least a 75% reduction in the Hand Eczema Severity Index, called HECSI75, at week 16 compared with baseline.[2] HECSI is a score that measures how severe hand eczema is by looking at both extent and intensity of the disease.[2]

Main outcomes measured in the studies

In the COPD trial, the main endpoint was the annual rate of moderate and severe exacerbations over 52 weeks.[1] An endpoint is the main result researchers plan to measure in a trial.[1]

In the hand eczema trial, the main endpoint was HECSI75 at week 16.[2] This means the researchers checked how many patients improved by at least 75% on the HECSI scale after 16 weeks of treatment.[2]

These endpoints show that the studies were designed to measure real patient outcomes: fewer COPD flare-ups and better control of hand eczema symptoms.[1][2]

Study design, phases, and enrollment

Both studies were interventional, which means the researchers gave a treatment and compared it with placebo or another study arm.[1][2] This type of design helps show whether a treatment may make a difference.

  • NCT04636814 was a phase 3 COPD study with 3,978 participants and a completed status.[1]

  • 2022-503011-42-00 was a phase 2 hand eczema study with 40 participants and a completed status.[2]

The large difference in enrollment suggests that the COPD trial was meant to test the treatment in a much bigger group, while the hand eczema study was an earlier and smaller trial.[1][2]

Patient-friendly explanation of key terms

Maintenance therapy means the regular treatment a patient already uses to keep a chronic condition under control.[1] In the COPD study, Roflumilast was studied as an add-on to this ongoing treatment.[1]

Placebo is a look-alike treatment without the active study drug.[1][2] It helps researchers compare results fairly.

Baseline means the starting point before treatment begins.[2] In the hand eczema trial, the HECSI score at week 16 was compared with the baseline score.[2]

Moderate and severe exacerbations are worsening episodes of COPD symptoms that are serious enough to matter in daily life and medical care.[1] The COPD study measured how often these events happened over one year.[1]

HECSI is a scoring system for hand eczema severity.[2] HECSI75 means a 75% or greater improvement in that score.[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 provided study chronic obstructive pulmonary disease (COPD) and chronic hand eczema. These are different conditions, so the research is looking at Roflumilast in two separate patient groups.
  • Who can take part in these trials? One trial included adults with chronic hand eczema, and another studied people with COPD. Each study has its own entry rules, so only patients who match the trial criteria can join.
  • What phases are the Roflumilast trials in? The source data includes a phase 2 trial and a phase 3 trial. Phase 2 studies usually look at early evidence of benefit and safety, while phase 3 studies test the treatment in a larger group.
  • What are the trials measuring? In COPD, the main outcome is the yearly rate of moderate and severe flare-ups over 52 weeks. In chronic hand eczema, the main outcome is the number of patients who reach at least a 75% improvement in disease severity by week 16.
  • Are these trials completed? Yes, both trials in the source data are marked as completed. This means the study treatment and follow-up were finished.

Igangværende kliniske forsøg for Roflumilast

  • Undersøgelse af ny medicin (CHF6001) til behandling af KOL som tillæg til eksisterende vedligeholdelsesbehandling

    Rekrutterer ikke

    1 1
    Undersøgte lægemidler:
    Østrig Bulgarien Kroatien Tjekkiet Estland Tyskland +8

  • Undersøgelse af lægemidlet roflumilast til behandling af kronisk håndeksem hos voksne

    Rekrutterer ikke

    1 1
    Undersøgte lægemidler:
    Danmark

Ordliste

  • Chronic obstructive pulmonary disease (COPD): A long-term lung disease that makes it hard to breathe. In the trial, researchers studied whether Roflumilast could help people with COPD who were already on maintenance triple therapy.
  • Chronic hand eczema: A long-lasting skin condition on the hands that can cause redness, itching, cracking, and irritation. One trial tested Roflumilast in adults with this condition.
  • Phase 2: An early stage of clinical research that looks at whether a treatment may work and whether it appears safe in a smaller group of patients.
  • Phase 3: A later stage of clinical research that tests a treatment in a larger group of patients to better understand its benefit and safety.
  • Interventional study: A study where participants receive a treatment or placebo so researchers can compare results.
  • Placebo: A look-alike treatment with no active study drug. It is used for comparison so researchers can see whether the study drug makes a difference.
  • Maintenance triple therapy: Ongoing COPD treatment using three medicines together: ICS, LABA, and LAMA. The COPD trial studied Roflumilast as an add-on to this treatment.
  • ICS: Inhaled corticosteroid, a medicine breathed into the lungs to help control inflammation in COPD treatment.
  • LABA: Long-acting beta agonist, a medicine used in COPD treatment to help keep airways open for a longer time.
  • LAMA: Long-acting muscarinic antagonist, a medicine used in COPD treatment to help relax and open the airways.
  • HECSI: Hand Eczema Severity Index, a score used to measure how severe hand eczema is.
  • HECSI75: A result meaning at least a 75% reduction in the HECSI score. In the hand eczema trial, this was the main measure of improvement.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/undersogelse-af-ny-medicin-chf6001-til-behandling-af-kol-som-tillaeg-til-eksisterende-vedligeholdelsesbehandling/
  2. https://clinicaltrials.gov/study/2022-503011-42-00