NCT00251056

Brief Summary

Many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology and replenishing the airway surface liquid layer in these patients, thereby enhancing the shift of stagnant mucus from the lungs. The study aim is to determine the optimal dose of mannitol to generate clinical improvement in patients with cystic fibrosis.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2005

Typical duration for phase_2

Geographic Reach
2 countries

12 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

June 30, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 9, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 29, 2008

Status Verified

August 1, 2008

Enrollment Period

2.8 years

First QC Date

June 30, 2005

Last Update Submit

August 27, 2008

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

  • FEV1

    2 weeks

  • FVC

    2 weeks

Secondary Outcomes (6)

  • other measures of lung function

    various

  • QOL

    2 weeks

  • sputum microbiology

    2 weeks

  • safety

    2 weeks

  • sputum clearance and cough

    2 weeks

  • +1 more secondary outcomes

Study Arms (4)

1

ACTIVE COMPARATOR
Drug: mannitol

2

ACTIVE COMPARATOR
Drug: mannitol

3

ACTIVE COMPARATOR
Drug: mannitol

4

ACTIVE COMPARATOR
Drug: mannitol

Interventions

mannitolDRUG

120mg BD

2

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of cystic fibrosis (sweat test/genotype)
  • years or older
  • FEV1 between 40% and 90% of predicted for height, age and gender.
  • Able to perform acceptable-quality spirometry
  • Clinically stable in the week up to study entry
  • No additional antibiotics or additional oral steroids for a period of 14 days before study entry (routine antibiotics permitted)

You may not qualify if:

  • Currently active asthma
  • Subjects colonized with Burkholderia cepacia or MRSA
  • Considered "terminally ill" or listed for transplantation
  • Requiring home oxygen or assisted ventilation
  • Concurrent illness that in the investigators opinion may contribute to an increased and unacceptable risk if the subject was enrolled in the study (e.g. significant varicies, portal hypertension, cor pulmonale)
  • Significant episode of haemoptysis (\>60 mLs) in the previous 12 months
  • Heart attack or stroke in last 3 months
  • Known aortic or cerebral aneurysm
  • Subjects who are breast feeding or pregnant.
  • At risk females unwilling to use appropriate contraception to prevent pregnancy during the course of the study
  • Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.
  • Known intolerance to mannitol or unable to take any form of bronchodilator medications.
  • Uncontrolled hypertension, systolic BP \> 200 or diastolic BP\> than 100
  • Concurrent use of beta blocker medication
  • Concurrent use of hypertonic saline
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hospital de Niños Superiora Sor María Ludovica

La Plata, Buenos Aires, B1904CSI, Argentina

Location

Hospital Pediatrico

Resistencia, Chaco Province, Argentina

Location

Hospital Interzonal Especializado Materno Infantil (HIEMI)

Buenos Aires, Argentina

Location

Hospital General de Niños

CABA, Argentina

Location

Hospital Pediatrico Dr Humberto J Notti

Mendoza, Argentina

Location

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

St Pauls Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

Janeway Children's Health and Rehabilitation Center

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8N 3Z5, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

St Michaels Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Elizabeth Tullis, MD

    St Michaels Hospital, Toronto, Ontario, Canada

    PRINCIPAL INVESTIGATOR

  • Brett Charlton, MBBS PhD

    Pharmaxis Ltd, Sydney, NSW, Australia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

November 9, 2005

Study Start

October 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 29, 2008

Record last verified: 2008-08

Locations

AR(5)CA(7)