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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) (PILLAR)

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ClinicalTrials.gov Identifier: NCT04636814
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: CHF6001 1600µg Drug: CHF6001 3200µg Drug: Placebo Drug: Roflumilast Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : July 12, 2021
Estimated Primary Completion Date : July 26, 2025
Estimated Study Completion Date : August 2, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast

Arms and Interventions
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Arm Intervention/treatment
Experimental: CHF6001 1600µg Drug: CHF6001 1600µg
CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily
Experimental: CHF6001 3200µg Drug: CHF6001 3200µg
CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily
Placebo Comparator: Placebo Drug: Placebo
CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily
Active Comparator: Roflumilast Drug: Roflumilast
- 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


Outcome Measures
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Primary Outcome Measures :
  1. The number of moderate and severe 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 corticosteroids (oral/IV/IM corticosteroids), and/or use of antibiotics
    • Severe : requiring hospitalisation or resulting in death


Secondary Outcome Measures :
  1. The time to first moderate or severe exacerbation. [ Time Frame: Up to 52 weeks ]
  2. The annual rate of severe exacerbations. [ Time Frame: Up to 52 weeks ]
  3. The time to first severe exacerbation. [ Time Frame: Up to 52 weeks ]
  4. The number of all on-treatment severe exacerbations. [ Time Frame: Up to 52 weeks ]
  5. The number of all on-treatment exacerbations requiring systemic corticosteroids. [ Time Frame: Up to 52 weeks ]
  6. Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52. [ Time Frame: At week 52 ]
  7. Change from baseline in SGRQ total and domain scores at week 52. [ Time Frame: At week 52 ]
  8. SGRQ response (change from baseline SGRQ total score ≤ -4) at week 52. [ Time Frame: At week 52 ]
  9. Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores. [ Time Frame: Up to 52 weeks ]
  10. E-RS response (change from baseline E-RS Total score ≤ -2) at week 52. [ Time Frame: At week 52 ]
  11. 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 ]
  12. Time to study medication discontinuation for any reason. [ Time Frame: Up to 52 weeks ]
  13. 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 ]
  14. Time to 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. [ Time Frame: Up to 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 COPD emphysema or mixed phenotypes.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04636814


Contacts
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Contact: Chiesi Clinical Trial info + 39 0521 279 715 clinicaltrials_info@chiesi.com

Locations
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Bulgaria
Chiesi Clinical Trial - Site 100524 Recruiting
Stara Zagora, Bulgaria
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Fernando J. MARTINEZ, Prof. Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 New York 10021 USA
More Information
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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT04636814    
Other Study ID Numbers: CLI-06001AA1-05
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chiesi Farmaceutici S.p.A.:
COPD
chronic bronchitis
PDE4 inhibitor
anti-inflammatory respiratory drug
Tanimilast
Additional relevant MeSH terms:
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Bronchitis
Bronchitis, Chronic
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
 Respiratory Tract Diseases
Respiratory Tract Infections
Infections
Bronchial Diseases