This is a Phase 2 study of the efficacy, safety, tolerability and pharmacokinetics of two doses of EXPD-101 in participants with COPD. Study participants will be randomized to receive either study drug or placebo administered once daily for 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
600
DM Clinical Research - Phoenix
Phoenix, Arizona, United States
Annualized rate of moderate and severe COPD exacerbations
Effect of EXPD-101/FXS7553 compared with placebo on rate of moderate and severe COPD exacerbations. Moderate COPD exacerbation is defined as acute exacerbations of COPD that require either systemic corticosteroids (intramuscular (IM), intravenous, or oral) and/or antibiotics. Severe COPD exacerbation is defined as acute exacerbation of COPD requiring hospitalization or emergency room / urgent care visit ≥ 24 hours.
Time frame: Over 52 Weeks
The number of participants experiencing an adverse events (AEs)
The number of participants experiencing an AE (an AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship) will be presented.
Time frame: Over 52 weeks
Changes in vital sign parameters
Vital signs, including systolic and diastolic BP (mmHg), heart rate (beats per minute), body temperature (°C), and respiratory rate will be listed and summarized.
Time frame: Over 52 weeks
Changes in electrocardiogram (ECG) parameters
ECG (graphical tracing that records the electrical signals of your heartbeat) parameters will be summarized.
Time frame: Over 52 weeks
Number of Participants with Clinically Significant Changes in Physical Examination Findings
Physical examination will be performed at each study visit by a qualified investigator. The following body systems will be assessed: ears, nose, throat, skin, cardiovascular, respiratory, musculoskeletal, and neurological.
Time frame: Over 52 weeks
Number of participants with clinically significant abnormalities
Clinical laboratory assessments including hematology, serum chemistry, and urinalysis will be performed at each study visit.
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California Medical Research Associates Inc.
Northridge, California, United States
RECRUITINGLynn Institute of Denver
Aurora, Colorado, United States
RECRUITINGInternational Clinical Research
Altamonte Springs, Florida, United States
RECRUITINGNature Coast Clinical Research
Crystal River, Florida, United States
RECRUITINGClinical Site Partners, LLC Leesburg dba Flourish Research
Leesburg, Florida, United States
RECRUITINGSuncoast Research Group, LLC Miami - Little Havana dba Flourish Research
Miami, Florida, United States
RECRUITINGOptimal Research Sites
Orange, Florida, United States
RECRUITINGCentricity Research Columbus
Rincon, Georgia, United States
NOT_YET_RECRUITINGDM Clinical Research-Indianapolis
Indianapolis, Indiana, United States
RECRUITING...and 10 more locations
Time frame: Over 52 weeks
Changes in Physical Exam Parameters - Body Weight
Body weight measured using a calibrated scale at each study visit
Time frame: Over 52 weeks
Time to first moderate or severe COPD exacerbation
Effect of EXPD-101/FXS7553 compared with placebo on time to first moderate or severe COPD exacerbation.
Time frame: Over 52 Weeks
Change From Baseline in Quality of Life Questionnaire - St. George's Respiratory Questionnaire (SGRQ)
The SGRQ is a validated, self-administered patient-reported outcome (PRO) that assesses symptoms, functioning, and health-related quality of life for participants with Chronic Obstructive Pulmonary Disease (COPD). It contains 50 items in 2 parts. Part 1 has 8 items for assessing the severity of respiratory symptoms (cough, sputum production, wheeze, breathlessness, and the duration and frequency of attacks of breathlessness or wheeze). Part 2 has 42 items across 2 components (Activity and Impacts) related to daily activities and psychosocial impacts of the participant's respiratory condition. The SGRQ total score is calculated as the sum of scores across symptoms, activity, and effects, with 0 indicating the best possible health status and 100 indicating the worst possible health status. A decrease in 4 units in the total score corresponds to a clinically significant improvement in the quality of life.
Time frame: Baseline, Week 52
Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1) and forced vital capacity (FVC)
FEV1 is used to assess lung function and is the maximum amount of air that can be forced out in one second after first second after taking a forced expiration as measured by a spirometer. Postbronchodilator FEV1 tests included spirometry tests performed after administration of bronchodilator. FVC is used to assess lung function and is the total volume of air that can be forced out after taking a deep breath as measured by a spirometer.
Time frame: Baseline, Week 52
Change From Baseline at Week 52 in Quality of Life Questionnaire - Evaluating Respiratory Symptoms (E-RS): COPD
The E-RS:COPD™ scale, a part of the EXACT tool, is a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. The E-RS is an 11-item participant-reported diary to measure respiratory symptom items contained in the 14-item EXACT. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity. In addition to the total score, symptom domain scores can be calculated for breathlessness (5 items; score range: 0-17), cough and sputum (3 items; score range: 0-11) and chest symptoms (3 items; score range: 0-12) by summing the responses of items within a respective domain. As with the total score, higher domain scores indicate greater severity.
Time frame: Baseline, Week 52
Annualized rate of severe COPD exacerbations
Effect of EXPD-101/FXS7553 compared with placebo on rate of severe COPD exacerbations.
Time frame: Over 52 Weeks
Plasma Concentration and metabolites of EXPD-101/FXS755
Time frame: Pre-dose at baseline, and Weeks 2, 4, 12, 28, 52 and 56.
Change from Baseline in sputum neutrophil elastase (NE) activity
Effect of EXPD-101/FXS7553 compared with placebo on sputum neutrophil elastase (NE) activity.
Time frame: Over 52 Weeks
Annualized rate of COPD exacerbations requiring Emergency Department visit and/or hospitalization
Effect of EXPD-101/FXS7553 compared with placebo on rate of COPD exacerbations requiring Emergency Department visit and/or hospitalization.
Time frame: Over 52 Weeks