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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

The subject must:
1. Have given written informed consent to participate in this study in accordance with local regulations
2. Have documented evidence of confirmed diagnosis of (non-CF) bronchiectasis by CT, HRCT or bronchogram
3. Be aged 18 – 80 years inclusive
4. Have FEV1 40 - 80% predicted* or =1.0L (according to NHANESIII predicted tables)
5. Documented history of at least 2 pulmonary exacerbations, each requiring antibiotic therapy, per year for the 2 years prior to study entry
6. Have chronic sputum production of >1 tablespoonful per day on the majority of days in the 3 months prior to visit 0
7. Have chronic chest congestion ( defined as chronic excessive accumulation of mucus in the lungs)
8. Be able to perform all the 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

The subject must NOT:
1. Be investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
2. Have bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion
3. Be considered terminally ill” or listed for transplantation
4. Be using hypertonic saline in the 4 weeks prior to commencing treatment
5. Have previously used inhaled mannitol for more than a day
6. Have had a significant episode of hemoptysis (>60 mL) in the previous 6 months
7. Have had antibiotics in the 4 weeks prior to V1 except chronic macrolide therapy
8. Have active signs and symptoms of asthma *
9. Have smoked within the last 3 months or ex-smokers with greater than 20 pack years (number of pack years = (number of cigarettes per day / 20) x number of years smoked, e.g., 20 cigarettes per day for 20 years, or 40 cigarettes per day for 10 years).
10. Have had a myocardial infarction in the three months prior to enrolment
11. Have had a cerebral vascular accident in the three months prior to enrolment
12. Have had major ocular surgery in the three months prior to enrolment
13. Have had major abdominal, chest or brain surgery in the three months prior to enrolment
14. Have a known cerebral, aortic or abdominal aneurysm
15. Have actively treated Mycobacterium tuberculosis
16. Have actively treated nontuberculous mycobacterial infection
17. Have end stage interstitial lung disease
18. Have active malignancy including melanoma (other skin carcinomas and remissions > 2 years exempted)
19. Be breast feeding or pregnant, or plan to become pregnant while in the study
20. Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
21. Be participating in another investigational drug study, parallel to, or within 4 weeks of study entry
22. Have a known intolerance to mannitol or ß2-agonists
23. Have uncontrolled hypertension – e.g. for adults: systolic BP > 190 and or diastolic BP > 100
24. Subject 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 the patient’s participation in the study

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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