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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 492

Inclusion Criteria

1) Age at least 18 years;
2) Proven and documented diagnosis of non-CF idiopathic or post-infectious BE by CT scan (conventional high resolution CT is considered the standard) including 2 or more lobes and dilated airways compatible with BE at initial diagnosis
3) Positive culture from an adequate sputum sample for Pseudomonas aeruginosa, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Stenotrophomonas maltophilia or Burkholderia cepacia obtained at screening and with history =2 documented exacerbations in the past 12 months.
4) Stable pulmonary status as indicated by FEV1 (percent of predicted) >=30% and <90% (post-bronchodilator, if used as standard of treatment);
5) Stable regimen of standard treatment with:
o 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
o Macrolides if used as chronic treatment for BE for at least 6 months prior to screening.
6) Sputum production on the majority of days;
7) Ability to follow the inhaler device instructions;
8) Ability to complete questionnaires;
9) Written informed consent;
10) Negative urine pregnancy test result for women of childbearing potential before first dose of study drug;
11) 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 246
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 246

Exclusion Criteria

1) FEV1 <30% or >=90% predicted (post-bronchodilator);
2) Active allergic bronchopulmonary aspergillosis (ABPA);
3) Active and actively-treated non-tuberculosis mycobacterial (NTM) infection or tuberculosis;
4) Diagnosis of common variable immunodeficiency (CVID);
5) Recent significant hemoptysis (>=300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period);
6) Primary diagnosis of COPD;
7) Known CF and / or documented chronic bronchial asthma;
8) Administration of any investigational drug within 4 weeks before screening;
9) Medical history of allergies to quinolones or fluoroquinolones;
10) Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
11) History of tendon disorders related to quinolone treatment;
12) History of myasthenia gravis;
13) Concomitant administration of tizanidine while on study drug;
14) Systemic or inhaled antibiotic treatment for any indication within 4 weeks prior to the administration of study drug; except for chronic macrolide use (see section 6.9).
15) Systemic corticosteroids at >10 mg/day prednisolone equivalent for >14 days within 4 weeks prior to the administration of study drug;
16) If participating in or has participated in other investigational
interventional studies within the previous 4 weeks before screening;
17) Subjects with any other conditions (specifically those which are addressed in the warnings and precautions section of the IB) or clinically relevant laboratory findings that the investigator defines as not appropriate for enrollment of a subject into the study
18) Previous assignment to treatment in this study (randomized in Study 15626);subjects who have participated in RESPIRE 1 will not beenrolled in RESPIRE 2.

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

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