Bronchiectasis
Conditions
Interventions
Product Name: Inhaled mannitol
Pharmaceutical Form: Inhalation powder, hard capsule
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Sponsors
Pharmaxis Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent. Documented evidence of confirmed diagnosis of bronchiectasis. Aged 18 to 85 years inclusive. FEV1 >= 40% and = 1.0L. Clinician documented history of at least 2 exacerbations requiring antibiotic treatment, in the 12 months prior to study, and at least 4 in 2 years prior to study. 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
Exclusion criteria
Exclusion criteria: 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 study: 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. Previous screen failure for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the difference in the rates of graded pulmonary exacerbations, in patients with bronchiectasis treated with inhaled mannitol compared to placebo control.;Primary end point(s): Pulmonary exacerbation rates (graded exacerbations).; Secondary Objective: To evaluate the difference in: -Quality of Life as measured by the St. Georges Respiratory Questionnaire (SGRQ). -Antibiotic use prescribed for treated pulmonary exacerbations. Such antibiotic use parameters to be ananlyzed will include number of discrete courses; days on antibiotics; and time to antibiotic need. -Sputum volume. -Daytime sleepiness scores. -Lung functions (FEV1, FVC, FEV1/FVC. FEF25-75 values). -(Exploratory) to investigate the difference in the number of hospitalisations due to pulmonary exacerbations. To evaluate the difference in other graded exacerbation parameters (time to first exacerbation and duration of exacerbation). To monitor the safety profile of inhaled mannitol compared with placebo control in subjects with bronchiectasis by investigating adverse events, airway reactivity, hematology, clinical chemistry, sputum microbiology and vital signs. To compare health status and utility scores (cost effectiveness). | — |
Countries
Belgium, Germany, Netherlands, United Kingdom
Outcome results
None listed