In short
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.
Key points
- Clinical trials of Roflumilast in this set focus on two different conditions: COPD and chronic hand eczema. The COPD study was a large Phase 3 trial in people already receiving maintenance triple therapy, and it measured moderate and severe flare-ups over 52 weeks. The chronic hand eczema study was a smaller Phase 2 trial in adults with this skin condition, and it measured whether patients reached HECSI75 at week 16. Both studies were completed. Together, they show that Roflumilast has been studied in both lung and skin disease populations.
Overview of the trials
These clinical trials studied Roflumilast in two different diseases: chronic obstructive pulmonary disease (COPD) and chronic hand eczema. Both studies were interventional, which means the researchers gave a treatment and compared results across groups. Both trials were completed.
COPD Phase 3 study
The COPD trial, NCT04636814, was a Phase 3 study with 3,978 participants. It studied people with COPD who were already on maintenance triple therapy, meaning regular treatment with three medicines used together to control the disease. 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.
The main goal was to see whether add-on treatment could reduce the number of moderate and severe exacerbations over 52 weeks. An exacerbation is a flare-up, or worsening, of COPD symptoms. This type of outcome helps show whether a treatment can lower the burden of flare-ups over time.
Chronic hand eczema Phase 2 study
The hand eczema trial, 2022-503011-42-00, was a Phase 2 study with 40 adult participants. It studied oral Roflumilast 500 micrograms compared with placebo in people with chronic hand eczema. A placebo is a look-alike treatment with no active study drug, used to help compare results fairly.
The study aimed to find out whether Roflumilast could improve eczema severity and whether it was safe in adults with this skin condition. The trial focused on a specific patient group with long-lasting hand eczema, not on COPD.
Key outcomes measured
In the COPD study, the main outcome was the annual rate of moderate and severe exacerbations over 52 weeks. This means the researchers counted how often patients had flare-ups during one year.
In the hand eczema study, the main outcome was the proportion of patients who reached HECSI75 at week 16. HECSI is a score that measures hand eczema severity by looking at how much skin is affected and how intense the disease is. HECSI75 means the score improved by at least 75% from the start of the study.
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. The trial designs were different because the diseases and goals were different.
The COPD study was much larger and later-stage, while the chronic hand eczema study was smaller and earlier-stage. Together, they help researchers understand whether Roflumilast may be useful in specific patient groups and what outcomes should be measured in future research.