Bronchiectasis
Conditions
Interventions
Product Name: DP Mannitol
Pharmaceutical Form: Inhalation powder, hard capsule
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route
Sponsors
Pharmaxis UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Evidence of confirmed diagnosis of (non CF) bronchiectasis by HRCT (2) Age: 15 – 80 years inclusive (3) FEV1 50% - 80% predicted and =1.0L (4) Chronic cough (defined as persistently troublesome cough present on the majority of days in the 3 months prior to enrolment) (5) Chronic sputum production of >10 mL per day on the majority of days in the 3 months prior to study entry (6) Chronic chest congestion ( defined as chronic excessive accumulation of mucus in the lungs) (7) Ability to perform all the techniques necessary to measure lung function, and (8) Stable clinical condition at the time of, and for a period of 14 days prior to recruitment; defined as lack of: (a) change in techniques for sputum clearance (b) change in sputum production (volume, colour, consistency) (c) new or increased haemoptysis (d) increased cough (e) worsening dyspnoea (f) increased malaise, fatigue or lethargy (g) reduction in exercise tolerance (h) fever (g) increase in weight loss or anorexia (h) sinus pain/tenderness or change in sinus discharge (i) gastrointestinal symptoms such as diarrhoea, constipation, nausea, vomiting or (j) additional antibiotics (routine antibiotics permitted) Are the trial subjects under 18? yes 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted (2) Bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion (3) “Terminally ill” patients or those listed for transplantation (4) Use of hypertonic saline or mucolytic pharmacological agents concurrently or in the 4 weeks prior to study entry (5) Patients previously enrollment in a clinical trial using Bronchitol that was administered for more than a day (6) Significant episode of haemoptysis (>60 mL) in the previous 6 months (7) Exacerbation for which intravenous antibiotics were prescribed in the 4 weeks prior to study entry (8) Presence of airway hyperresponsiveness as defined by a positive Aridol challenge (9) Smoking history of >10 pack years or if more than 1 cigarette smoked per week within the previous 3 months (10) Likeliness of developing bronchoconstriction in response to Bronchitol in the opinion of the investigator (11) Myocardial Infarction in the three months prior to enrolment (12) Cerebral vascular accident in the three months prior to enrolment (13) Major ocular surgery in the three months prior to enrolment (14) Major abdominal, chest or brain surgery in the three months prior to enrolment (15) Presence of cerebral, aortic or abdominal aneurysm (16) Active tuberculosis (17) Active malignancy including melanoma (other skin carcinomas and remissions exempted) (18) Females who are breast feeding or pregnant or plan to become pregnant during the study (19) At risk females unwilling to use appropriate contraception to prevent pregnancy during the study (20) Patients participating in another investigative drug study, parallel to, or within 4 weeks of study entry (21) Known intolerance to mannitol or ß-agonists (22) Uncontrolled hypertension – systolic BP > 190 and or diastolic BP > 100 or (23) Patient has a condition or is in a situation which in the Investigator’s opinion may put the subject at significant risk, may confound results or may interfere significantly with participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1) Assessment of the effects of Bronchitol on quality of life as measured by a change in the score of the St George’s Respiratory Questionnaire; (2) Assessment of the impact of Bronchitol on mucus clearance (24 hour sputum sample); Main Objective: The study has two co-primary objectives: (1) to assess whether the effects of Bronchitol are beneficial to the quality of life in subjects with bronchiectasis using the St George’s Respiratory Questionnaire; and (2) to assess the impact of Bronchitol on mucus clearance (24 hour sputum sample) ; Secondary Objective: Efficacy: To assess the impact of Bronchitol on: (1) bronchiectasis symptoms (2) cough severity (3) exercise capacity (4) lung function, including gas transfer (5) antibiotic use (6) bronchial wall thickening and inflammation and (7) peripheral airway function Safety: To demonstrate the safety profile of Bronchitol (adverse events, haematology, biochemistry, sputum microbiology) | — |
Countries
United Kingdom
Outcome results
None listed