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) (PILASTER)
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|ClinicalTrials.gov Identifier: NCT04636801|
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : October 25, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Experimental: CHF6001 1600µg Drug: Experimental: CHF6001 3200µg Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2985 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 52-week, Randomized, Double-blind, Placebo-controlled, 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|
|Actual Study Start Date :||July 14, 2021|
|Estimated Primary Completion Date :||October 26, 2024|
|Estimated Study Completion Date :||November 2, 2024|
|Experimental: CHF6001 1600µg||
Drug: Experimental: CHF6001 1600µg
CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).
|Experimental: CHF6001 3200µg||
Drug: Experimental: CHF6001 3200µg
CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).
|Placebo Comparator: CHF6001 Placebo||
CHF6001 matching placebo, 2 inhalations bid.
- The number of moderate and severe COPD exacerbations occurring during the planned 52-week treatment period. [ Time Frame: Up to 52 weeks ]
Moderate or severe exacerbation is defined by symptomatic worsening of COPD:
- Moderate: requiring use of systemic corticosteroid (oral/IV/IM corticosteroids), and/or use of antibiotics
- Severe: requiring hospitalisation or resulting in death
- The time to first moderate or severe exacerbation. [ Time Frame: Up to 52 weeks ]
- The annual rate of severe exacerbation. [ Time Frame: Up to 52 weeks ]
- The time to first severe exacerbation. [ Time Frame: Up to 52 weeks ]
- The number of on-treatment severe exacerbations. [ Time Frame: Up to 52 weeks ]
- Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52. [ Time Frame: At Week 52 ]
- Change from baseline in SGRQ total and domain scores at week 52. [ Time Frame: At week 52 ]
- SGRQ response (change from baseline SGRQ total score ≤ -4) at week 52. [ Time Frame: At week 52 ]
- Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores [ Time Frame: Up to 52 weeks ]
- E-RS response (change from baseline E-RS Total score ≤ -2) at week 52. [ Time Frame: 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) [ Time Frame: Up to 52 weeks ]
- Time to study medication discontinuation for any reason. [ Time Frame: 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 Frame: Up to 52 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||40 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Adults aged ≥ 40 years with COPD and chronic bronchitis
- Current or ex-smokers (history ≥ 10 pack years).
- Post-bronchodilator FEV1 <80% 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 ≥ 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 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636801
|Contact: Chiesi Clinical Trial firstname.lastname@example.org|
|Chiesi Clinical Trial - Site 100423||Recruiting|
|Principal Investigator:||Klaus F. Rabe, Prof.||LungenClinic Grosshansdorf GmbH Wöhrendamm 80 22927 Großhansdorf GERMANY|
|Responsible Party:||Chiesi Farmaceutici S.p.A.|
|Other Study ID Numbers:||
2020-003666-40 ( EudraCT Number )
|First Posted:||November 19, 2020 Key Record Dates|
|Last Update Posted:||October 25, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
anti-inflammatory respiratory drug
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections