MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis

Absolute Change in Percent Predicted Forced Expiratory Volume in One Second (FEV1)

FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).

Time frame: Baseline, day 28

Change From Baseline in Pseudomonas Aeruginosa Sputum Density

Pseudomonas aeruginosa density was measured as log10 colony-forming units \[CFU\] per gram sputum. LSMean and standard are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.

Time frame: Baseline, Day 28

Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R)

The Cystic Fibrosis Questionnaire (CFQ-R) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. LSMean and standard error were determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12 to 18 years, \> 18 years), Baseline FEV1 (\<55%, ≥ 55%), and Baseline value.

Time frame: Baseline, Day 28

Relative Change From Baseline in Percent Predicted FEV1

FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).

Time frame: Baseline, Day 28

Time to Administration of Other Systemic and/or Inhaled Antipseudomonal Antimicrobials

Participants who had at least one of four worsening respiratory symptoms (increased cough, increased sputum/chest congestion, decreased exercise tolerance, decreased appetite) at the time of administration of the anti-pseudomonal antimicrobial agent were included in the analysis. Median and 95% CI are estimated using Kaplan Meier estimates.

Time frame: Baseline to end of study (up to 59 days)

Time to First Hospitalization

Median and 95%CI was estimated using Kaplan Meier estimates.

Time frame: Baseline to end of study (up to 59 days)

Number of Participants With Treatment Emergent Adverse Events

An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a Study Drug, whether or not considered related to the Study Drug. An AE could potentially be a new disease, any untoward event, or an exacerbation of a pre-existing condition. AEs included, but were not limited to: * Any symptom not previously reported by the patient (medical history) * An exacerbation of a pre-existing illness * An increase in frequency or intensity of a pre-existing episodic event or condition * A condition first detected or diagnosed after Study Drug administration even though the condition may have been present before the start of the study * Overdose of Study Drug

Time frame: From start of study until end of study (Up to 59 days)