Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non-CF BE)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

-Age >=18 years;
-Proven and documented diagnosis of non-CF idiopathic or post-infectious BE by both:
* HRCT scan including 2 or more lobes and dilated airways compatible with BE at initial diagnosis;
and
* Positive culture from an adequate sputum sample for Pseudomonas aeruginosa, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Stenotrophomonas maltophilia or Burkholderia cepacia at screening and with history >=2 documented exacerbations in the past 12 months;
-Stable pulmonary status as indicated by FEV1 (percent of predicted) >= 30% and < 90% (post-bronchodilator, if used as standard of treatment);
-Stable regimen of standard treatment with:
* Bronchodilators, anticholinergics, inhaled corticosteroids, or mucolytics, if used as chronic treatment for BE, at least for the past 4 weeks prior to screening; Subjects on maintenance therapy with low-dose systemic corticosteroids should be receiving <=10 mg/day prednisolone equivalent at least for the past 4 weeks before the screening visit;
and/or
* Macrolides if used as chronic treatment for BE for at least 6 months prior to screening;
-Sputum production on the majority of days;
-Ability to follow the inhaler device instructions;
-Ability to complete questionnaires;
-Written informed consent;
-Negative urine pregnancy test result for women of childbearing potential before first dose of study drug;
-Women of childbearing potential and men must agree to use adequate contraception when sexually active. This applies from the time of signing of the informed consent form (ICF) until 3 months after the last study drug administration. Adequate methods of contraception include vasectomy, or condom use, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization, or oral contraceptives.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

-FEV1 <30% or >= 90% predicted (post-bronchodilator);
-Active allergic bronchopulmonary aspergillosis (ABPA);
-Active and actively-treated non-tuberculosis mycobacterial (NTM) infection or tuberculosis;
-Diagnosis of common variable immunodeficiency (CVID);
-Recent significant hemoptysis (>= 300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period);
-Primary diagnosis of COPD;
-Known CF and / or documented chronic bronchial asthma;
-Administration of any investigational drug within 4 weeks before screening;
-Medical history of allergies to quinolones or fluoroquinolones;
-Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
-History of tendon disease and other disorders related to quinolone treatment;
-History of myasthenia gravis;
-Concomitant administration of tizanidine while on study drug;
-Systemic or inhaled antibiotic treatment for any indication within 4 weeks prior to the administration of study drug; except for chronic macrolide use
-Systemic corticosteroids at >10 mg/day prednisolone equivalent for >14 days within 4 weeks prior to the administration of study drug
-Previous assignment to treatment in this study (randomized in Study 15625).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials