EUCTR2008-000264-17-GB进行中（未招募）不适用
A MULTI-CENTER, OPEN-LABEL, PROOF-OF-CONCEPT STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFECT ON SPUTUM PSEUDOMONAS AERUGINOSA DENSITY OF INHALED LIPOSOMAL CIPROFLOXACIN HYDROCHLORIDE IN ADULT SUBJECTS WITH NON-CF BRONCHIECTASIS - Not available
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients age 18 - 80 years, inclusive
- •Off any antipseudomonal antibiotic for a minimum of 14-days prior to screening visit
- •Confirmed diagnosis of non-CF bronchiectasis per HRCT
- •FEV1 at screening >/=25%
- •Positive P. aeruginosa in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit.
- •Sputum P. aeruginosa density = 6 log10 CFU/gram after at least 14-days off anti-pseudomonal antibiotics
- •Sputum P. aeruginosa is sensitive to ciprofloxacin
- •Clinically stable in the opinion of the investigator
- •Female subjects of child-bearing potential must be willing to undergo a pregnancy test and agree to use acceptable birth control at least 3 weeks prior to and 3 weeks after the study. To be considered not of child-bearing potential”, female subjects must be at least 2 years postmenopausal, or have been irreversibly surgically sterilized (by hysterectomy, oophorectomy, or bilateral tubal ligation). Acceptable methods of birth control for women are orally administered hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence.
- •Provide written informed consent to participate in the study and be willing to comply with all study procedures
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known or suspected local or systemic hypersensitivity to quinolone antibiotics
- •History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B. cepacia), within 2 years prior to screening and/or sputum culture yielding B. cepacia at the Screening visit
- •Sputum P. aeruginosa resistant to ciprofloxacin
- •Hemoptysis exceeding 50 mL of blood from the respiratory tract at any time within 30 days prior to study drug administration
- •Females who are pregnant (positive pregnancy test), lactating, or are planning to become pregnant during the study
- •Use of any anti-pseudomonal antibiotics (or other antibiotics) within 14 days of study drug administration
- •Participation in a clinical trial or receipt of an experimental therapy within 30 days prior to study dosing
- •Initiation of treatment with chronic macrolide therapy, or inhaled corticosteroids within 30 days prior to study drug administration (patients may be taking these therapies at the time of enrollment, but they must have initiated treatment more than 30 days prior to study drug administration)
- •Patients having an exacerbation during the screening process as defined as a requirement of inhaled, oral, or intravenous antibiotics prior to the first study dose will be excluded
- •Use of any over-the-counter product, herbal product, diet aid, hormone supplement, etc., within 7 days prior to dosing unless approved by both the Principal Investigator and the Sponsor
- •Patients having one or more of the concomitant illnesses described in detail in Section 8.7.1 of the protocol
- •Patients with clinically significant out of range laboratory values as stated in Section 8.6 of the protocol
研究者
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