NCT00277537

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2006

Geographic Reach
3 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

August 29, 2008

Status Verified

August 1, 2008

Enrollment Period

2.3 years

First QC Date

January 13, 2006

Last Update Submit

August 27, 2008

Conditions

Bronchiectasis

Keywords

Mannitol

Outcome Measures

Primary Outcomes (2)

  • 24 hour sputum clearance

    24 hours / 12 weeks

  • Quality of Life SGRQ

    12 weeks

Secondary Outcomes (9)

  • bronchiectasis symptoms

    12 weeks

  • cough severity

    12 weeks

  • exercise capacity

    12 weeks

  • lung function, including gas transfer

    12 weeks

  • antibiotic use

    12 weeks

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Mannitol

2

OTHER
Drug: placebo

Interventions

MannitolDRUG

320mg BD 12 weeks followed by 40 weeks open label

1
placeboDRUG

BD for 12 weeks

2

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Canberra Hospital

Canberra, Australian Capital Territory, Australia

Location

Royal Prince Alfred Hospital

Camperdown Sydney, New South Wales, Australia

Location

St George Hospital

Kogarah, New South Wales, Australia

Location

John Hunter Hospital

Newcastle, New South Wales, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Location

Bankstown Hospital

Sydney, New South Wales, Australia

Location

Mater Adult Hospital

Brisbane, Queensland, Australia

Location

Cairns Base Hospital

Cairns, Queensland, Australia

Location

Repatriation General Hospital

Adelaide, South Australia, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Burnside War Memorial Hospital

Toorak Gardens, Adelaide, South Australia, Australia

Location

Peninsula Health Frankston Hospital

Frankston, Victoria, Australia

Location

The Alfred Hospital

Melbourne, Victoria, Australia

Location

AARI Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Location

Royal Perth Hospital

Perth, Western Australia, Australia

Location

Greenlane Hospital

Auckland, New Zealand

Location

Middlemore Hospital

Auckland, New Zealand

Location

Belfast City Hospital

Belfast, Northern Ireland, United Kingdom

Location

Papworth Hospital

Cambridge, United Kingdom

Location

Glenfield Hospital

Leicester, United Kingdom

Location

North West Lung Centre, Wythshawe Hospital

Manchester, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Location

Related Publications (1)

  • Bilton D, Daviskas E, Anderson SD, Kolbe J, King G, Stirling RG, Thompson BR, Milne D, Charlton B; B301 Investigators. Phase 3 randomized study of the efficacy and safety of inhaled dry powder mannitol for the symptomatic treatment of non-cystic fibrosis bronchiectasis. Chest. 2013 Jul;144(1):215-225. doi: 10.1378/chest.12-1763.

    PMID: 23429964DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Brett Charlton

    Pharmaxis Ltd Australia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 16, 2006

Study Start

March 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

August 29, 2008

Record last verified: 2008-08

Locations

GB(5)AU(15)NZ(2)