Last updated 3 months ago
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)
3980 patients around the world
Available in Argentina
Chiesi Farmaceutici S.p.A.
2Research sites
3980Patients around the world
This study is for people with
Chronic obstructive pulmonary disease
Copd
Chronic bronchitis
Requirements for the patient
From 40 Years
All Gender
Medical requirements
- 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.
- Subjects with current asthma.Subjects with moderate or severe COPD exacerbation 4 weeks before study entry and randomisationSubjects 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.
Sites
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Centro Integral de Medicina Respiratoria (CIMER) - Tucumán
Recruiting
StudyPILLAR
SponsorChiesi Farmaceutici S.p.A.
Conditions
CopdChronic bronchitis
Requirements
From 40 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04636814
