Clareo Health | A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)
A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adults aged ≥ 40 years, with COPD and with chronic bronchitis.
Current smokers or ex-smokers (history of ≥10 pack years).
Post-bronchodilator FEV1 \<50% of the patient predicted normal value and FEV1/FVC ratio \< 0.7.
At least, one moderate or severe COPD exacerbation in the previous year.
CAT score ≥10.
Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit.
You may not be if
Subjects with current asthma.
Subjects with moderate or severe COPD exacerbation 4 weeks before study entry and randomisation
Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
Subjects with primary diagnosis of emphysema not related to COPD.
Subjects with known respiratory disorders other than COPD.
Subjects with lung volume reduction surgery.
Subjects with active cancer or a history of lung cancer.
Subjects under Roflumilast treatment within 6 months before study entry.
Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
Subjects with clinically significant cardiovascular condition.
Subjects with neurological disease.
Subjects with clinically significant laboratory abnormalities.
Subjects with moderate or severe hepatic impairment.
