PILLAR is a clinical research study to test the safety and effectiveness of an investigational medication given as an add-on treatment for Chronic Obstructive Pulmonary Disease (COPD). Participants who qualify for the study will receive trial-related procedures and study medication at no cost and may be compensated up to $85 per visit for time and travel.

Study Details:
  • This study is testing an investigational medication that is administered as a dry powder via an inhaler device. It is being compared to a similar approved oral medication (known as roflumilast, marketed as Daliresp) and a placebo (a placebo looks like the investigational drug but does not contain active ingredient).
  • All subjects will continue to take their current maintenance triple therapy during the study (including those who are taking placebo).
  • Participants will be randomly selected to receive either the investigational medication, the approved oral medication, or the placebo to be taken daily for one year. Study-provided medication will be taken in addition to your current daily COPD triple therapy medications. As usual, you will be able to take your own rescue therapy as needed.
  • Total study duration, including screening, is just over 1 year (56 weeks) with 8 office visits and 2 phone calls.
  • Study procedures and tests will include lung function assessments, blood sample collection, ECGs, and vital signs. You will also be required to complete daily electronic diary entries using a study provided device.
Eligibility Requirements:

Participants must:
  • Be 40 years of age and older
  • Reside within 75 miles of a designated clinical site (currently located in AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV)
  • Have a diagnosis of COPD with chronic bronchitis symptoms (productive cough, producing thick mucus/phlegm, may sound like rattling)
  • Have been on prescribed maintenance COPD triple therapy medication (ICS, LABA, and LAMA) for at least 12 months before entering the study (any kind of triple combination, such as Trelegy Ellipita™, Breztri Aerosphere™ or, for example, combinations of Pulmicort™, Budesonide, Beclomethasone, Formoterol™, Spiriva™ or comparable generic medications, etc.)
  • Be taking triple therapy medication for COPD at a stable doses and schedule for the last 3 months
  • Have had 1 or more exacerbations/flare-ups of COPD symptoms that required antibiotics and/or
    corticosteroid treatment within the past year
  • Be a current or former smoker

    There’s no cost to participate in this study, and you do not need health insurance. Reimbursement for reasonable expenses such as travel may also be available for qualified participants.

    To find out if you are eligible for this COPD and Chronic Bronchitis Treatment study, you will be asked to complete a short pre-screening questionnaire.

    By completing this questionnaire, you acknowledge that the COPD Foundation has your consent to review your responses in order to assist clinical research coordinators with enrollment for this study. If you are eligible for the study you will be asked to provide your name and contact information for scheduling a follow-up phone screening interview by the COPD Foundation Study Coordinator. If you qualify for this study, the COPD Foundation will provide your contact details and questionnaire answers to the PILLAR study clinical site coordinator in your region. Please note that all information collected in this questionnaire will be kept confidential. Click to view Chiesi's Clinical Trial Transparency and Data Sharing Policy Statment.

Question Title

* 1. Please confirm that you would like to complete the study pre-screening questionnaire and acknowledge that the COPD Foundation has your consent to review your responses to confirm eligibility in order to assist clinical research coordinators with enrollment for this study.

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