Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
FLUIDDA nv
Age
30–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patient ≥ 30 years old
Written informed consent obtained
Patient with Body mass index (BMI) ≥ 20
Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
COPD patient with GOLD stages C and D
Patient with a Borg Fatigue score after the 6MWT on screening above 4 to indicate the susceptibility to dynamics hyperinflation
Patient with smoking history of at least 10 pack-years
Patient takes a combination therapy of LABA/ LAMA at least 6 weeks before visit 1
Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions
You may not be if
Pregnant or lactating females
Patient with severe immunological diseases and/ or severe acute infectious diseases
Patient with heart failure as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1
Patient with diagnosis of cancer (except basal cell carcinoma)
Patient with a history of depression associated with suicidal ideation or behaviour
Patient with moderate or severe hepatic impairment.
Patient with lactose intolerance
Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
Patient who received inhalation corticosteroids (ICS) within the last 6 weeks prior to the screening visit
Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer)
Clareo Health | Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging
