Safety and Efficacy of Bronchitol in Bronchiectasis

A Phase III Multicenter, Randomised, Parallel, Placebo-Controlled, Double-Blind Study to Investigate the Safety and Efficacy of Treatment With Bronchitol (Dry Powder Mannitol) in the Symptomatic Treatment of Bronchiectasis.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00277537

Enrollment

354

Registered

2006-01-16

Start date

2006-03-31

Completion date

2008-07-31

Last updated

2008-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

Keywords

Mannitol

Brief summary

Study will assess the safety and effectiveness of 12 week treatment with the study medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology (making it less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On completion of the double blind phase, subjects will have the opportunity to participate in a 52 week open label phase.

Interventions

DRUGMannitol

320mg BD 12 weeks followed by 40 weeks open label

DRUGplacebo

BD for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Non cystic fibrosis bronchiectasis * Have FEV1 50% - 80% predicted and ≥1.0L * Have chronic sputum production of \>10 mL per day on the majority of days in the 3 months prior to study entry

Exclusion criteria

* Be using hypertonic saline or mucolytic pharmacological agents concurrently or in the 4 weeks prior to study entry * Have airway hyperresponsiveness as defined by a positive Aridol challenge

Design outcomes

Primary

Measure	Time frame
24 hour sputum clearance	24 hours / 12 weeks
Quality of Life SGRQ	12 weeks

Secondary

Measure	Time frame
exercise capacity	12 weeks
lung function, including gas transfer	12 weeks
antibiotic use	12 weeks
bronchiectasis symptoms	12 weeks
adverse events	12 weeks / 12 months
haematology, biochemistry,	12 weeks / 12 months
sputum microbiology quantitative and qualitative	12 weeks / 12 months
bronchial wall thickening and inflammation	12 weeks
cough severity	12 weeks

Countries

Australia, New Zealand, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026