Clock Proteins as Prognostic Markers

The registry criteria, word for word

What the trial wants to find out

Asthma is a chronic inflammatory disease of the airways that follows a strong circadian rhythm: Signs of inflammation and symptoms worsen especially in the early morning hours. The molecular circadian clock, which is a complex machinery of transcriptional and translational feedback loops, seems to reflect the inflammatory environment of peripheral blood leukocytes. Therefore, in this observational study the investigators will monitor the molecular circadian clock in patients with severe eosinophilic asthma before and during mepolizumab treatment. Our major goal is to evaluate the potential of the molecular circadian clock to serve as a prognostic marker for disease progression, treatment response or remission in patients with severe eosinophilic asthma. The molecular circadian clock will be monitored in blood and sputum leukocytes from patients with severe eosinophilic asthma before mepolizumab treatment, after 4 month of mepolizumab therapy, and once they reach remission under mepolizumab treatment. Effects will be compared to healthy controls and patients with mild-moderate asthma without mepolizumab treatment.

The 3 groups in the trial

• healthy controls

  For healthy controls, participation in this study lasts only one day. The following samples will be collected at three time-points on the same day (4 am, 12 pm, 8 pm): Blood sampling: 80 mL citrated whole blood and 10 mL serum will be collected. Collection of spontaneous sputum: at least 5 ml of sputum are collected. Saliva collection: Saliva is also collected at all three time-points.

• mild-to-moderate asthma

  For patients with mild-to-moderate asthma, participation in this study lasts only one day. The following samples will be collected at three time-points on the same day (4 am, 12 pm, 8 pm): Blood sampling: 80 mL citrated whole blood and 10 mL serum will be collected. Collection of spontaneous sputum: at least 5 ml of sputum are collected. Saliva collection: Saliva is also collected at all three time-points.

• severe eosinophilic asthma

  Patients with severe eosinophilic asthma, will be monitored (i) before mepolizumab treatment, (ii) after 4 months of mepolizumab treatment, (iii) once they reach remission under mepolizumab treatment. Mepolizumab is already approved for the treatment of severe eosinophilic asthma and is not administered for study purposes but as a standard treatment. On the day of participation, the following samples will be collected at three time-points (4 am, 12 pm, 8 pm): Blood sampling: 80 mL citrated whole blood and 10 mL serum will be collected. Collection of spontaneous sputum: at least 5 ml of sputum are collected. Saliva collection: Saliva is also collected at all three time-points.