To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment

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.

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.

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.

Changes in electrocardiogram (ECG) parameters

ECG (graphical tracing that records the electrical signals of your heartbeat) parameters will be summarized.

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.

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.

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.

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.