Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

This study has been completed.

Sponsor:

Information provided by:

Pharmaxis

ClinicalTrials.gov Identifier:

NCT00117208

First received: June 30, 2005

Last updated: January 31, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2005

Last Updated Date

January 31, 2010

Start Date ^ICMJE

November 2005

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase [ Time Frame: 12 weeks ]

Original Primary Outcome Measures ^ICMJE

FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase

Change History

Complete list of historical versions of study NCT00117208 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

to compare mannitol to rhDNase on FVC [ Time Frame: 12 weeks ]
to assess whether the effects of mannitol are additive to rhDNase [ Time Frame: 12 weeks ]
to demonstrate that mannitol does not cause deterioration in airway inflammation [ Time Frame: 12 weeks ]
to assess whether mannitol reduces the bacterial load in the lung [ Time Frame: 12 weeks ]
to assess whether the effects of mannitol are beneficial to quality of life [ Time Frame: 12 weeks ]
to assess whether mannitol, or mannitol + rhDNase are cost-effective compared to rhDNase alone [ Time Frame: 12 weeks ]

Original Secondary Outcome Measures ^ICMJE

to compare mannitol to rhDNase on FVC
to assess whether the effects of mannitol are additive to rhDNase
to demonstrate that mannitol does not cause deterioration in airway inflammation
to assess whether mannitol reduces the bacterial load in the lung
to assess whether the effects of mannitol are beneficial to quality of life
to assess whether mannitol, or mannitol + rhDNase are cost-effective compared to rhDNase alone

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

Official Title ^ICMJE

A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis

Brief Summary

The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

Drug: mannitol
400mg BD for 12 weeks
Drug: mannitol + pulmozyme
combination
Drug: Dornase alpha
2.5mg daily for 2 weeks

Other Name: rhDNase, pulmozyme

Study Arm (s)

Experimental: 1
Intervention: Drug: mannitol
Active Comparator: 2
DNase daily for 12 weeks

Intervention: Drug: Dornase alpha
3
combination

Intervention: Drug: mannitol + pulmozyme

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Known diagnosis of cystic fibrosis (sweat test or genotype)
Of either gender
Aged between 8 and 18 years
Have a baseline FEV1 of <70% of the predicted normal value
Currently taking rhDNase for at least 4 weeks

Exclusion Criteria:

Currently active asthma, uncontrolled hypertension, colonised with Burkholderia cepacia or MRSA
Listed for transplantation
Known intolerance to mannitol, rhDNase or bronchodilators

Gender

Both

Ages

8 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00117208

Other Study ID Numbers ^ICMJE

DPM-CF-203

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pharmaxis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Andrew Bush, FRCPCH	Royal Brompton and Harefiled NHS Trust
Principal Investigator:	Colin Wallis, FRCPCH	Great Ormond Street Hospital for Children NHS Foundation Trust

Information Provided By

Pharmaxis

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top