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, Randomized, Double-blind, Double-dummy, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg), Parallel Group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Triple Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04636814

Acronym

PILLAR

Enrollment

3973

Registered

2020-11-19

Start date

2021-07-12

Completion date

2025-12-23

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, chronic bronchitis, PDE4 inhibitor, anti-inflammatory respiratory drug, Tanimilast

Brief summary

The purpose of this study is to evaluate the efficacy and the safety of two doses of CHF6001 (Tanimilast) as add-on to maintenance triple therapy in the target patient population.

Interventions

DRUGCHF6001 1600µg

CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily

DRUGCHF6001 3200µg

CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily

DRUGPlacebo

CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily

DRUGRoflumilast

\- 1 tablet of Roflumilast (Daliresp®), 250µg, once daily during the first 4 weeks of treatment then 1 tablet of Roflumilast (Daliresp®), 500µg, once daily for the remaining treatment period and CHF6001 matching placebo, 2 inhalations bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
The number of moderate and severe exacerbations occurring during the planned 52-week treatment period.	Up to 52 weeks	Moderate or severe exacerbation is defined by symptomatic worsening of COPD: * Moderate : requiring use of systemic corticosteroids (oral/IV/IM corticosteroids), and/or use of antibiotics * Severe : requiring hospitalisation or resulting in death

Secondary

Countries

Argentina, Austria, Bosnia and Herzegovina, Bulgaria, Chile, Croatia, Czechia, Estonia, Germany, Greece, Hungary, Israel, Latvia, Mexico, Netherlands, New Zealand, North Macedonia, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States

Contacts

PRINCIPAL_INVESTIGATORFernando J. MARTINEZ, Prof.

Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Measure	Time frame	Description
The time to first moderate or severe exacerbation.	Up to 52 weeks	The time to first moderate or severe exacerbation.
The annual rate of severe exacerbations.	Up to 52 weeks	The annual rate of severe exacerbations.
The time to first severe exacerbation.	Up to 52 weeks	The time to first severe exacerbation.
The number of all on-treatment severe exacerbations.	Up to 52 weeks	The number of all on-treatment severe exacerbations.
The number of all on-treatment exacerbations requiring systemic corticosteroids.	Up to 52 weeks	The number of all on-treatment exacerbations requiring systemic corticosteroids.
Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.	At week 52	Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.
Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.	At week 52	Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.
Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52.	At week 52	Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52.
Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.	Up to 52 weeks	Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.
E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.	At week 52	E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.
Change from baseline to last inter-visit period (week 40-52) in the percentage of days without intake of rescue medication and in the average rescue medication use (number of puffs).	Up to 52 weeks	Change from baseline to last inter-visit period (week 40-52) in the percentage of days
Time to study medication discontinuation for any reason.	Up to 52 weeks	Time to study medication discontinuation for any reason.
Time to moderate or severe exacerbation or study medication discontinuation due to any adverse event, lack of efficacy or death (composite endpoint) and time to study medication discontinuation component.	Up to 52 weeks	Time to moderate or severe exacerbation or study medication discontinuation due to any adverse event, lack of efficacy or death (composite endpoint) and time to study medication discontinuation component.
Time to first moderate/severe exacerbation or study medication discontinuation due to any class-related AE, lack of efficacy, or death (composite endpoint) and time to study medication discontinuation component.	Up to 52 weeks	Time to first moderate/severe exacerbation or study medication discontinuation due to any class-related AE, lack of efficacy, or death (composite endpoint) and time to study medication discontinuation component.
Key Secondary Variable: Change from baseline in SGRQ Total score at week 52	At week 52	Key Secondary Variable: Change from baseline in SGRQ Total score at week 52