Clinical Trial Search

Primary: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). — -2.94; -0.32 log10 of CFU per gram sputum — p=< 0.001

Primary: Time to First Exacerbation Event Within 48 Weeks — 336; NA; 186 Days — p=0.0650

Primary: 24 Hour Sputum Volume — 41.8; 23.6; 29.9; 26.2 gram — p=<0.01

Primary: Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo — NA; NA Days — p=0.0511

Primary: Nontuberculous Mycobacterial (NTM) Disease — 188; 32 Events — p=0.19

Primary: Median Number of Exacerbations — 1; 2 exacerbations

Primary: Change in QOL-B Respiratory Symptoms Score at Day 28 — 7.4; 5.7 units on a scale — p=0.68

Primary: Change in QOL-B Respiratory Symptoms Score at Day 28 — 8.2; 3.2 units on a scale — p=0.011

Primary: Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period — NA; NA; 189.0 days — p== 0.014

Primary: Lung Function: Lung Clearance Index — 9; 9.7 lung clearance index

Primary: Bronchiectasis Exacerbation — 0.98; 0.75 proportion of acute exacerbations

Primary: Average Rate of Mucociliary Clearance (MCC) Over 60 Minutes — 14.8 percent cleared over 60 minutes — p=0.04

Primary: Annualized Rate of Pulmonary Exacerbations (PEs) — 1.015; 1.036; 1.286 exacerbation per participant-year — p==0.0019

Primary: Rate of Graded Pulmonary Exacerbations — 1.95; 2.10; 1.69; 1.84 GPE events per year — p=0.3115

Primary: Occurrence of Any Treatment Emergent Adverse Events — 85.7; 93.3 Percentage of participants

Primary: Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response — 0.87; 2.51 Percent of predicted — p=0.092

Primary: Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) — 0.80 Intraclass Correlation Coefficient

Primary: Time to an Exacerbation — 58; 51.5 Days — p=0.0715

Primary: Change in P. Aeruginosa Density — 0.23; -0.31; -0.31; -0.73 log10 CFU/g sputum — p=0.0014

Primary: Change in FEV1 — -0.07; -0.08 Liters

Primary: Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks — 60; 71; 84; 69 cmH2O — p=0.005

Primary: Bacterial Clearance Rate of Sputum — 38; 16 Participants

Primary: Sweat Chloride Concentration — NA mmol/L

Primary: The Number of Participants With Blood and Sputum Samples Collected — 18; 27; 0; 14 Participants

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 90; 180 participants

Primary: Absolute Change in FEV1 % Predicted From Visit 1 to Visit 3 Between ERR-10 Day and ERR-14 Day — 13.30; 13.83 percentage change — p=0.0164

Primary: Computed Tomography Evidence of Less Sinus Disease — 5.875; 3 units on a scale — p=0.2

Primary: Sufficient Sputum Quantity for a Pellet — 9 Participants

Primary: The Change in Sputum Density of BCC in Colony Forming Units (CFUs)/ml From Day 0 to Day 28 of TIP Treatment. — -1.4 CFU/ml log10

Primary: The Ability of the Breath Test Model to Distinguish Bronchiectasis From Healthy People — 65; 67; 23 Participants — p=<0.05