Efficacy and Safety of CP006 Inhalation Powder in Participants With Asthma

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
The goal of this clinical trial is to evaluate whether two different doses of aninvestigational drug (CP006 Inhalation Powder, a triple combination of budesonide,formoterol, and umeclidinium) improve lung function in adults with asthma compared to anactive comparator (budesonide/formoterol inhalation powder, a marketed two‐componentproduct).The main questions it aims to answer are:Does CP006 produce a greater change in lung function (measured by trough FEV₁ beforemorning dose) after 28 days of treatment compared to the comparator? What medicalproblems do participants experience when taking CP006? Researchers will compare two doselevels of CP006 against the active comparator in a 1:1:1 ratio.Participants will:Complete a screening visit (up to 7 days) to confirm eligibility, including medicalhistory, physical exam, and lung function tests Enter a 14‐day run‐in period during whichthey take the comparator medication (budesonide/formoterol) twice daily Be randomlyassigned to one of three treatment groups: CP006 Dose 1, CP006 Dose 2, or the comparatorTake their assigned treatment twice daily for 28 days Visit the clinic at Day 0(baseline), Day 8, Day 15, and Day 29 for lung function tests, safety checks, andquestionnaires (ACQ‐5 and AQLQ) Measure their morning and evening peak expiratory flow(PEF) daily using a handheld device and record the results in a diary Return for afollow‐up safety visit or phone call at Day 43 (±2 days) The total duration ofparticipation is approximately 58 to 65 days.
Epistemonikos ID: 6bcb5f096f998b93fed6181962f33b6ea999bb1d
First added on: Sep 09, 2026