A phase 3, multi-center, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin inhalation solution (APT-1026) in stable cystic fibrosis patients

Journal of Cystic Fibrosis

Volumn 15, Issue 4, 2016, Pages 495-502

  Flume, Patrick A ^a   VanDevanter, Donald R ^b   Morgan, Elizabeth E ^c   Dudley, Michael N ^c   Loutit, Jeffery S ^c   Bell, Scott C ^d   Kerem, Eitan ^e   Fischer, Rainald ^f   Smyth, Alan R ^g   Aaron, Shawn D ^h   Conrad, Douglas ⁱ   Geller, David E ^j   Elborn, J Stuart ^k  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^b CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c Medicines Company   (United States)

^d QIMR BERGHOFER MEDICAL RESEARCH INSTITUTE   (Australia)

^e HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^f Krankenhaus München Pasing   (Germany)

^g UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^h OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

ⁱ UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^j FLORIDA STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

^k QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

more..

Author keywords

Aerosol; Antibiotics; Cystic fibrosis; Fluoroquinolone; Pseudomonas

Indexed keywords

GLUCOSE; LEVOFLOXACIN; PLACEBO; ANTIINFECTIVE AGENT;

ADULT; ANTIBIOTIC THERAPY; ARTHRALGIA; ARTICLE; CLOSTRIDIUM DIFFICILE INFECTION; CONTROLLED STUDY; CONVULSION; COUGHING; CRACKLE; CYSTIC FIBROSIS; DECREASED APPETITE; DISEASE COURSE; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSGEUSIA; DYSPNEA; EXERCISE TOLERANCE; EYE TOXICITY; FATIGUE; FEMALE; FEVER; FORCED EXPIRATORY VOLUME; GLUCOSE BLOOD LEVEL; HEADACHE; HEMOPTYSIS; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; LUNG CONGESTION; MAJOR CLINICAL STUDY; MALE; MEDICAL NEBULIZER; MULTICENTER STUDY; MYASTHENIA GRAVIS; NAUSEA; OROPHARYNX PAIN; OUTCOME ASSESSMENT; PARANASAL SINUS DISEASE; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; PHOTOTOXICITY; PSEUDOMEMBRANOUS COLITIS; PSEUDOMONAS INFECTION; PSYCHOSIS; QT PROLONGATION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; RETINA DETACHMENT; SIDE EFFECT; SINUS HEADACHE; SINUSITIS; SKIN TOXICITY; SPUTUM DISCOLORATION; SPUTUM VISCOSITY; TENDINITIS; TENDON RUPTURE; TREATMENT DURATION; WEIGHT REDUCTION; ADOLESCENT; CHRONIC DISEASE; CLINICAL TRIAL; DRUG EFFECTS; DRUG MONITORING; INHALATIONAL DRUG ADMINISTRATION; ISOLATION AND PURIFICATION; MICROBIOLOGY; PATHOPHYSIOLOGY; PROCEDURES; PSEUDOMONAS AERUGINOSA; PSYCHOLOGY; RECURRENT DISEASE; SYMPTOM ASSESSMENT; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; ANTI-BACTERIAL AGENTS; CHRONIC DISEASE; CYSTIC FIBROSIS; DOUBLE-BLIND METHOD; DRUG MONITORING; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; LEVOFLOXACIN; MALE; PSEUDOMONAS AERUGINOSA; PSEUDOMONAS INFECTIONS; QUALITY OF LIFE; SYMPTOM ASSESSMENT; SYMPTOM FLARE UP; TREATMENT OUTCOME;

EID: 84957049727     PISSN: 15691993     EISSN: 18735010     Source Type: Journal    
DOI: 10.1016/j.jcf.2015.12.004     Document Type: Article

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