ACTIVE_NOT_RECRUITING

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)

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Conditions

Chronic Obstructive Pulmonary DiseaseCOPDchronic bronchitisPDE4 inhibitoranti-inflammatory respiratory drugTanimilast

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2021-07-12
Study Completion:2025-12-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04636814

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged ≥ 40 years, with COPD and with chronic bronchitis.
  2. * Current smokers or ex-smokers (history of ≥10 pack years).
  3. * Post-bronchodilator FEV1 \<50% of the patient predicted normal value and FEV1/FVC ratio \< 0.7.
  4. * At least, one moderate or severe COPD exacerbation in the previous year.
  5. * CAT score ≥10.
  6. * 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.
  1. * Subjects with current asthma.
  2. * Subjects with moderate or severe COPD exacerbation 4 weeks before study entry and randomisation
  3. * Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
  4. * Subjects with primary diagnosis of emphysema not related to COPD.
  5. * Subjects with known respiratory disorders other than COPD.
  6. * Subjects with lung volume reduction surgery.
  7. * Subjects with active cancer or a history of lung cancer.
  8. * Subjects under Roflumilast treatment within 6 months before study entry.
  9. * Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
  10. * Subjects with clinically significant cardiovascular condition.
  11. * Subjects with neurological disease.
  12. * Subjects with clinically significant laboratory abnormalities.
  13. * Subjects with moderate or severe hepatic impairment.

Contacts and Locations

Principal Investigator

Fernando J. MARTINEZ, Prof.
PRINCIPAL_INVESTIGATOR
Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA

Study Locations (Sites)

Chiesi Clinical Trial - Site 840635
Andalusia, Alabama, 36420-5310
United States
Chiesi Clinical Trial - Site 840614
Foley, Alabama, 36535-2248
United States
Chiesi Clinical Trial - Site 840670
Guntersville, Alabama, 35976-2206
United States
Chiesi Clinical Trial - Site 840720
Mobile, Alabama, 36608
United States
Chiesi Clinical Trial - Site 840643
Saraland, Alabama, 36571-3014
United States
Chiesi Clinical Trial - Site 840638
Phoenix, Arizona, 85018-5434
United States
Chiesi Clinical Trial - Site 840684
Conway, Arkansas, 72032
United States
Chiesi Clinical Trial - Site 840675
Laguna Hills, California, 92653-5509
United States
Chiesi Clinical Trial - Site 840666
Los Angeles, California, 90017-5649
United States
Chiesi Clinical Trial - Site 840511
Newport Beach, California, 92663-3661
United States
Chiesi Clinical Trial - Site 840680
Northridge, California, 91324-6200
United States
Chiesi Clinical Trial - Site 840605
Northridge, California, 91324
United States
Chiesi Clinical Trial - Site 840700
Pomona, California, 91768
United States
Chiesi Clinical Trial - Site 840531
Westminster, California, 92708
United States
Chiesi Clinical Trial - Site 840636
Centennial, Colorado, 80112-1406
United States
Chiesi Clinical Trial - Site 840688
Lakewood, Colorado, 80228
United States
Chiesi Clinical Trial - Site 840735
Brooksville, Florida, 34613
United States
Chiesi Clinical Trial - Site 840513
Chiefland, Florida, 32626
United States
Chiesi Clinical Trial - Site 840652
Clearwater, Florida, 33756
United States
Chiesi Clinical Trial - Site 840569
Clearwater, Florida, 33765-2103
United States
Chiesi Clinical Trial - Site 840545
Coral Gables, Florida, 33135
United States
Chiesi Clinical Trial - Site 840603
Cutler Bay, Florida, 33144-2566
United States
Chiesi Clinical Trial - Site 840587
Cutler Bay, Florida, 33189-1230
United States
Chiesi Clinical Trial - Site 840568
Cutler Bay, Florida, 33189
United States
Chiesi Clinical Trial - Site840539
Daytona Beach, Florida, 33470-9216
United States
Chiesi Clinical Trial - Site 840554
DeBary, Florida, 32713-2260
United States
Chiesi Clinical Trial - Site 840625
Doral, Florida, 33014-2426
United States
Chiesi Clinical Trial - Site 840572
Doral, Florida, 33122-1902
United States
Chiesi Clinical Trial - Site 840685
Hialeah, Florida, 33010-4103
United States
Chiesi Clinical Trial - Site 840504
Hialeah, Florida, 33012-3618
United States
Chiesi Clinical Trial - Site 840639
Hialeah, Florida, 33015-2952
United States
Chiesi Clinical Trial - Site 840582
Hialeah, Florida, 33015-6003
United States
Chiesi Clinical Trial - Site 840617
Hialeah, Florida, 33016-2753
United States
Chiesi Clinical Trial - Site 840514
Hialeah, Florida, 33186-5331
United States
Chiesi Clinical Trial - Site 840637
Hialeah Gardens, Florida, 33016
United States
Chiesi Clinical Trial - Site 840509
Hollywood, Florida, 33021
United States
Chiesi Clinical Trial - Site 840730
Hollywood, Florida, 33024
United States
Chiesi Clinical Trial - Site 840565
Homestead, Florida, 33256
United States
Chiesi Clinical Trial - Site 840674
Loxahatchee Groves, Florida, 33470
United States
Chiesi Clinical Trial - Site 840732
Melbourne, Florida, 32934
United States
Chiesi Clinical Trial - Site 840624
Miami, Florida, 33125-5114
United States
Chiesi Clinical Trial - Site 840596
Miami, Florida, 33126-1921
United States
Chiesi Clinical Trial - Site 840556
Miami, Florida, 33126-1926
United States
Chiesi Clinical Trial - Site 840602
Miami, Florida, 33135-2967
United States
Chiesi Clinical Trial - Site 840507
Miami, Florida, 33144-2100
United States
Chiesi Clinical Trial - Site 840519
Miami, Florida, 33144-4273
United States
Chiesi Clinical Trial - Site 840505
Miami, Florida, 33144-5037
United States
Chiesi Clinical Trial - Site 840644
Miami, Florida, 33144
United States
Chiesi Clinical Trial - Site 840557
Miami, Florida, 33155-1694
United States
Chiesi Clinical Trial - Site 840588
Miami, Florida, 33155-4630
United States
Chiesi Clinical Trial - Site 840618
Miami, Florida, 33155-6538
United States
Chiesi Clinical Trial - Site 840525
Miami, Florida, 33155-6541
United States
Chiesi Clinical Trial - Site 840656
Miami, Florida, 33155-6542
United States
Chiesi Clinical Trial - Site 840622
Miami, Florida, 33155
United States
Chiesi Clinical Trial - Site 840537
Miami, Florida, 33165-2075
United States
Chiesi Clinical Trial - Site 840691
Miami, Florida, 33165-2470
United States
Chiesi Clinical Trial - Site 840503
Miami, Florida, 33175-3598
United States
Chiesi Clinical Trial - Site 840694
Miami, Florida, 33184-1176
United States
Chiesi Clinical Trial - Site 840630
Miami, Florida, 33185
United States
Chiesi Clinical Trial - Site 840506
Miami Gardens, Florida, 33014-6426
United States
Chiesi Clinical Trial - Site 840608
Miami Lakes, Florida, 33014-2425
United States
Chiesi Clinical Trial - Site 840524
Orlando, Florida, 32807-3555
United States
Chiesi Clinical Trial - Site 840563
Orlando, Florida, 32825
United States
Chiesi Clinical Trial - Site 840702
Pembroke Pines, Florida, 14000
United States
Chiesi Clinical Trial - Site 840502
Pembroke Pines, Florida, 33024-3618
United States
Chiesi Clinical Trial - Site 840550
Pembroke Pines, Florida, 33024-6442
United States
Chiesi Clinical Trial - Site 840527
Pompano Beach, Florida, 33064-3547
United States
Chiesi Clinical Trial - Site 840654
South Miami, Florida, 33143-4960
United States
Chiesi Clinical Trial - Site 840699
St. Petersburg, Florida, 33707-6129
United States
Chiesi Clinical Trial - Site 840697
St. Petersburg, Florida, 33713-8900
United States
Chiesi Clinical Trial - Site 840567
Tampa, Florida, 33613-3740
United States
Chiesi Clinical Trial - Site 840632
Winter Park, Florida, 32789
United States
Chiesi Clinical Trial - Site 840542
Adairsville, Georgia, 30103-2438
United States
Chiesi Clinical Trial - Site 840728
College Park, Georgia, 30349
United States
Chiesi Clinical Trial - Site 840717
Columbus, Georgia, 31904
United States
Chiesi Clinical Trial - Site 840710
Cordele, Georgia, 31015
United States
Chiesi Clinical Trial - Site 840689
East Point, Georgia, 30344
United States
Chiesi Clinical Trial - Site 840726
Stonecrest, Georgia, 30038
United States
Chiesi Clinical Trial - Site 840564
Valdosta, Georgia, 31605-1096
United States
Chiesi Clinical Trial - Site 840724
Muncie, Indiana, 46303
United States
Chiesi Clinical Trial - Site 840672
Zachary, Louisiana, 70791-4010
United States
Chiesi Clinical Trial - Site 840645
Annapolis, Maryland, 21401
United States
Chiesi Clinical Trial - Site 840661
Baltimore, Maryland, 21224-6821
United States
Chiesi Clinical Trial - Site 840707
North Dartmouth, Massachusetts, 02747-1271
United States
Chiesi Clinical Trial - Site 840657
Troy, Michigan, 48085
United States
Chiesi Clinical Trial - Site 840658
Port Gibson, Mississippi, 39150
United States
Chiesi Clinical Trial - Site 840641
Saint Charles, Missouri, 63301-2835
United States
Chiesi Clinical Trial - Site 840714
St Louis, Missouri, 63110
United States
Chiesi Clinical Trial - Site 840541
St Louis, Missouri, 63141
United States
Chiesi Clinical Trial - Site 840669
St Louis, Missouri, 63141
United States
Chiesi Clinical Trial - Site 840686
Omaha, Nebraska, 68178
United States
Chiesi Clinical Trial - Site 840703
Henderson, Nevada, 89052
United States
Chiesi Clinical Trial - Site 840529
Las Vegas, Nevada, 89106-4159
United States
Chiesi Clinical Trial - Site 840701
North Las Vegas, Nevada, 89030-7193
United States
Chiesi Clinical Trial - Site 840722
Bayonne, New Jersey, 07002
United States
Chiesi Clinical Trial - Site 840667
Buffalo, New York, 14203-1070
United States
Chiesi Clinical Trial - Site 840678
New Windsor, New York, 12553-7754
United States
Chiesi Clinical Trial - Site 840520
New York, New York, 10021-0005
United States
Chiesi Clinical Trial - Site 840705
New York, New York, 10029-6500
United States
Chiesi Clinical Trial - Site 840626
The Bronx, New York, 10455
United States
Chiesi Clinical Trial - Site 840604
The Bronx, New York, 10468-6401
United States
Chiesi Clinical Trial - Site 840664
Charlotte, North Carolina, 28210-0106
United States
Chiesi Clinical Trial - Site 840721
Charlotte, North Carolina, 28273
United States
Chiesi Clinical Trial - Site 840610
Denver, North Carolina, 28037-7930
United States
Chiesi Clinical Trial - Site 840659
Gastonia, North Carolina, 28054-7481
United States
Chiesi Clinical Trial - Site 840540
Huntersville, North Carolina, 28078-5082
United States
Chiesi Clinical Trial - Site 840523
New Bern, North Carolina, 28562-5238
United States
Chiesi Clinical Trial - Site 840708
Shelby, North Carolina, 28150
United States
Chiesi Clinical Trial - Site 840621
Winston-Salem, North Carolina, 27103
United States
Chiesi Clinical Trial - Site 840627
Cincinnati, Ohio, 45236
United States
Chiesi Clinical Trial - Site 840713
Columbus, Ohio, 43228
United States
Chiesi Clinical Trial - Site 840647
Dayton, Ohio, 45419-4336
United States
Chiesi Clinical Trial - Site 840646
Toledo, Ohio, 43617-1178
United States
Chiesi Clinical Trial - Site 840668
Oklahoma City, Oklahoma, 73104
United States
Chiesi Clinical Trial - Site 840692
Tulsa, Oklahoma, 74133-5829
United States
Chiesi Clinical Trial - Site 840671
Philadelphia, Pennsylvania, 19107-5109
United States
Chiesi Clinical Trial - Site 840683
Philadelphia, Pennsylvania, 19140
United States
Chiesi Clinical Trial - Site 840578
Anderson, South Carolina, 29621-4822
United States
Chiesi Clinical Trial - Site 840592
Charleston, South Carolina, 29412-2625
United States
Chiesi Clinical Trial - Site 840528
Fort Mill, South Carolina, 29701
United States
Chiesi Clinical Trial - Site 840598
North Charleston, South Carolina, 29420
United States
Chiesi Clinical Trial - Site 840696
Rock Hill, South Carolina, 29732-1160
United States
Chiesi Clinical Trial - Site 840660
Franklin, Tennessee, 37067
United States
Chiesi Clinical Trial - Site 840546
Franklin, Tennessee, 38305
United States
Chiesi Clinical Trial - Site 840553
Knoxville, Tennessee, 37909-1161
United States
Chiesi Clinical Trial - Site 840535
Baytown, Texas, 77521-2416
United States
Chiesi Clinical Trial - Site 840634
Boerne, Texas, 78006-1993
United States
Chiesi Clinical Trial - Site 840704
Carrollton, Texas, 14000
United States
Chiesi Clinical Trial - Site 840566
Cypress, Texas, 77429-4696
United States
Chiesi Clinical Trial - Site 840706
Dallas, Texas, 75246
United States
Chiesi Clinical Trial - Site 840716
Houston, Texas, 77008
United States
Chiesi Clinical Trial - Site 840698
Houston, Texas, 77030
United States
Chiesi Clinical Trial - Site 840574
Kerrville, Texas, 78028-9640
United States
Chiesi Clinical Trial - Site 840551
McKinney, Texas, 75069
United States
Chiesi Clinical Trial - Site 840575
Mesquite, Texas, 75149-2438
United States
Chiesi Clinical Trial - Site 840741
North Richland Hills, Texas, 76180-7319
United States
Chiesi Clinical Trial - Site 840663
Pearland, Texas, 77584-7401
United States
Chiesi Clinical Trial - Site 840609
Plano, Texas, 75025
United States
Chiesi Clinical Trial - Site 840673
San Antonio, Texas, 78215-1528
United States
Chiesi Clinical Trial - Site 840681
San Antonio, Texas, 78229
United States
Chiesi Clinical Trial - Site 840711
San Antonio, Texas, 78229
United States
Chiesi Clinical Trial - Site 840729
San Antonio, Texas, 78229
United States
Chiesi Clinical Trial - Site 840597
San Antonio, Texas, 78258
United States
Chiesi Clinical Trial - Site 840600
Sherman, Texas, 75092-7351
United States
Chiesi Clinical Trial - Site 840552
Sugar Land, Texas, 77479-3481
United States
Chiesi Clinical Trial - Site 840526
Tomball, Texas, 77373
United States
Chiesi Clinical Trial - Site 840693
Portsmouth, Virginia, 23703
United States
Chiesi Clinical Trial - Site 840709
Everett, Washington, 98208
United States
Chiesi Clinical Trial - Site 840562
Morgantown, West Virginia, 26505-0423
United States
Chiesi Clinical Trial - Site 840532
Greenfield, Wisconsin, 53228-3467
United States

Collaborators and Investigators

Sponsor: Chiesi Farmaceutici S.p.A.

  • Fernando J. MARTINEZ, Prof., PRINCIPAL_INVESTIGATOR, Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-12
Study Completion Date2025-12-26

Study Record Updates

Study Start Date2021-07-12
Study Completion Date2025-12-26

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Chronic Obstructive Pulmonary Disease