A phase III multicenter, randomized, parallel, controlled, double blind study to investigate the safety and efficacy of inhaled mannitol over 12 months in the treatment of bronchiectasis.

Pharmaxis Ltd.0 个研究点目标入组 474 人开始时间: 2010年10月21日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•Written informed consent.
•Documented evidence of confirmed diagnosis of bronchiectasis.
•Aged 18 to 85 years inclusive.
•FEV1 >= 40% and <= 85% predicted and >= 1.0L.
•Clinician documented history of at least 2 exacerbations requiring antibiotic treatment, in the 12 months prior to V0A, and at least 4 in 2 years prior to V0A.
•SGRQ score >=30
•24 hour sputum production >=10g
•Chronic sputum production >= 15mL per day on majority of days in 3 months prior to study.
•Ability to perform techniques necessary to measure lung function.
•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

•Investigators, site personnel directly affiliated with the study, or immediate families. Bronchiectasis as a result of cystic fibrosis, focal endobronchial lesion or otherwise curable causes.
•Terminally ill or listed for transplantation, end stage interstitial lung disease.
•Use of hypertonic saline in the 14 days before, or use during study.
•Any previous use of mannitol for more than one day.
•Significant episode of haemoptysis (>60mL) in the 6 months prior to study.
•Rescue antibiotics in the 4 weeks prior to study.
•Any of the following in the 3 months prior to V0A: smoking; myocardial infarction;cerebral vascular accident; major ocular, abdominal, chest or brain surgery. Known cerebral, aortic or abdominal aneurysm.
•Actively treated mycobacterium tuberculosis or non active infection requiring treatment.
•Unstable ABPA requiring steroid therapy.
•Active malignancy.
•Breast feeding or pregnant or planning to become pregnant or using unreliable contraception.
•Participation in another study.
•Known intolerance to mannitol or B agonists.
•Uncontrolled hypertension.
•Any condition deemed by the Investigator to put the patient at risk or seriously confound the study result.

发起方