| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01180634 | MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis | PHASE3 | COMPLETED | 330 | — | — | Nov 4, 2010 | May 7, 2012 | Dec 18, 2024 | 112 | United States, Australia +3 |
The start of the exacerbation was determined by the earliest date at which a participant concurrently met at least 4 of the 12 modified Fuchs symptoms/signs; discontinued from the study early; died; or received an antipseudomonal agent for an event that did not meet modified Fuchs criteria but was determined to be an exacerbation by the Blinded Exacerbation. Fuchs symptoms/signs; * Change in sputum * New or increased hemoptysis * Increased cough * Increased dyspnea * Malaise, fatigue or lethargy * Temperature above 38oC * Anorexia or weight loss * Sinus pain or tenderness * Change in sinus discharge * Change in physical examination of the chest * Decrease in pulmonary function by 10 percent or more from a previously recorded value * Radiographic changes indicative of pulmonary infection Median and 95%Ci were estimated using Kaplan Meier estimates.
| Arm | Type | Description |
|---|---|---|
| Aeroquin 240 mg | EXPERIMENTAL | Participants received 240 milligrams (mg) of Aeroquin by inhalation route twice daily (BID) for a period of 28 days. |
| Placebo | PLACEBO_COMPARATOR | Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days. |
| Name | Type | Description |
|---|---|---|
| Aeroquin | DRUG | Inhalation Solution |
| Placebo | DRUG | Inhalation Solution |
Inclusion Criteria (selected): * \>/= 12 years of age * Confirmed Diagnosis of Cystic Fibrosis * Positive sputum culture for P. aeruginosa at screening and within the past 12 months * Patients are able to elicit an FEV1 \>/= 25% but \</= 85% of predicted value at screening * Have received at least ...
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|---|---|---|---|---|
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