None listed
Conditions
Interventions
Post-Screening, subjects will be randomized to Pulmaquin or inhaled placebo. The study drug will be administered by inhalation once daily (6 mL total) during six 28-day On-treatment Periods. Subjects
Sponsors
Aradigm Corporation,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Are willing and able to provide written informed consent. 2. Are males or females who are 18 year of age or older and are able to walk. 3. Have had a confirmed diagnosis of non-CF bronchiectasis per computerized tomography (or high resolution computerized tomography) showing bronchial wall dilatation (internal bronchial lumen diameter greater than accompanying pulmonary artery or lack of tapering) with or without bronchial wall thickening. 4. Have a documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics within the last 12 months. 5. Have forced expiratory volume in 1 second (FEV1) ≥ 25% of predicted values at the Screening Visit (Visit 0). 6. Have positive documented P. aeruginosa in a sputum/deep-throat swab culture (or bronchoalveolar lavage [BAL] or bronchoscopic specimen) prior to the Screening Visit (Visit 0). Subjects without documented P. aeruginosa prior to Screening who meet all other eligibility criteria must have at least two sputum samples or deep-throat swabs collected 3-4 or more weeks apart from each other during the 42-day Screening Phase. Two of the samples collected must test positive for P. aeruginosa. These two positive tests must be from samples taken a minimum of 3-4 or more weeks apart. 7. Have positive P. aeruginosa in the sputum/deep-throat swab culture collected at the Screening Visit (Visit 0) and at least one P. aeruginosa isolate non-resistant to ciprofloxacin. If the sputum sample is negative for P. aeruginosa, or only shows resistant P. aeruginosa isolates, the sputum/swab culture can be repeated multiple times during Screening to document the presence of P. aeruginosa. In subjects without documented P. aeruginosa prior to Screening who meet all other eligibility criteria and who had two or more sputum cultures or deep-throat swab cultures obtained 3-4 or more weeks apart from each other during Screening, at least one P. aeruginosa isolate taken after 3-4 or more weeks must be non-resistant to ciprofloxacin for the subject to be considered eligible for randomization. The qualifying sputum culture results must be available within the 42-day Screening Phase.
Exclusion criteria
Exclusion criteria: 1. Presentar una exacerbacion pulmonar durante la Fase de Seleccion (entre la firma del ICF y la aleatorizacion), definida como la necesidad de tratamiento agudo con antibioticos inhalados, orales o intravenosos. 2. Presentar diagnostico clinico de FQ. 3. Presentar diagnostico primario de Enfermedad Pulmonar Obstructiva Cronica (EPOC) relacionada con un historial de tabaquismo de mas de 10 paquetes año. 4. Presentar diagnostico actual de aspergilosis broncopulmonar alergica activa. 5. Haber recibido cualquier antibiotico antipseudomona intravenoso, oral o inhalado (excepto los macrolidos cronicos eritromicina, claritromicina o azitromicina con dosis estable) dentro de 28 dias antes de la Visita 1. 6. Tener alergia a ciprofloxacino, gemifloxacino, levofloxacino, moxifloxacino o norfloxacino. 7. Tener alergia conocida a productos de soja. 8. Haber utilizado tizanidina dentro de 28 dias antes de la Visita 1 y que necesitaria utilizar tizanidina durante el estudio (porque la tizanidina esta contraindicada debido a una interaccion PK con ciprofloxacino). 9. Haber iniciado oxigeno suplementario dentro de 28 dias antes de la Visita 1. 10. Haber utilizado cualquier corticosteroide intravenoso o intramuscular o haber utilizado corticosteroide oral > 10 mg/dia o > 20 mg en dias alternos (equivalentes de prednisona o prednisolona) dentro de 28 dias de la Visita 1. 3. Have primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) related to smoking history of greater than 10 pack years. 4. Have a current diagnosis of active allergic bronchopulmonary aspergillosis. 5. Have received any intravenous, oral, or inhaled anti-pseudomonal antibiotic (except chronic macrolides erythromycin, clarithromycin or azithromycin with a stable dose) within 28 days prior to Visit 1. 6. Have an allergy to ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, or norfloxacin. 7. Have a known allergy to soy products. 8. Have used tizanidine within 28 days prior to Visit 1 and would need to use tizanidine during the study (because tizanidine is contraindicated due to a PK interaction with ciprofloxacin). 9. Have initiated supplemental oxygen within 28 days prior to Visit 1.
Countries
Andorra, Colombia, Hungary, Ireland, Israel, Italy, Mexico, Peru, Spain, United Kindgdom, United States
Contacts
Public ContactAracely Galvez Durand
INTRIALS-PERU INVESTIGACIONES CLINICAS S.R.L.
Outcome results
None listed