Last updated 4 months ago
A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)
3435 patients around the world
Available in Argentina
Chiesi Farmaceutici S.p.A.
22Research sites
3435Patients 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 chronic bronchitisCurrent or ex-smokers (history ≥ 10 pack years).Post-bronchodilator FEV1 <60% of the subject predicted normal value and FEV1/FVC ratio < 0.7.At least, one moderate or severe COPD exacerbation in previous year.CAT score ≥ 10Subjects 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
- Subjects with current asthma.Subjects with moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization.Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.Subjects with COPD emphysema or mixed phenotypes.Subjects with known respiratory disorders other than COPD.Subjects with active cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy.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.Subjects with a significant neurological disease.Subjects with clinically significant laboratory abnormalities.Subjects with moderate or severe hepatic impairment
Sites
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Centro Respiratorio Quilmes - Buenos Aires
Recruiting
Sala de Primeros Auxilios Alberto Mignaburu - Berazategui, Prov Buenos Aires
Recruiting
Centro de Investigaciones Médicas Mar del Plata SRL
Recruiting
Centro Médico Respire S.R.L. - San Fernando - Buenos Aires
Recruiting
CEPIR - La Plata
Recruiting
Instituto de Medicina Respiratoria IMER - Córdoba
Recruiting
StudyPILASTER
SponsorChiesi Farmaceutici S.p.A.
Study typeInterventional
Conditions
CopdChronic bronchitis
Requirements
From 40 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04636801
