Not Signed In -
Cystic Fibrosis |
CF; Cystic Fibrosis Research Directions; Fibrocystic Disease of Pancreas; Mucoviscidosis |
Clinical Trial: Comparison of Inhaled Mannitol and rhDNase in Children with Cystic Fibrosis
This study is not yet open for patient recruitment.
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Cystic Fibrosis | Drug: mannitol Drug: pulmozyme Drug: mannitol + pulmozyme | Phase II |
MedlinePlus related topics: Cystic Fibrosis
Genetics Home Reference related topics: cystic fibrosis
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title: A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination with Daily rhDNase, in Children with Cystic Fibrosis
Secondary Outcomes: 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
Expected Total Enrollment: 42
Study start: September 2005; Expected completion: December 2007
Last follow-up: September 2007; Data entry closure: October 2007
Eligibility
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
Location and Contact Information
Rebecca Hindle, BSc +61 2 94547205 Rebecca.Hindle@pharmaxis.com.au
United Kingdom
Royal Brompton Hospital, London, United Kingdom
Caro Minasian caro.minasian@hotmail.com
Andrew Bush, FRCPCH, Principal Investigator
Caro Minasian, Sub-Investigator
Great Ormond Hospital for Children, London, United Kingdom
Caro Minasian caro.minasian@hotmail.com
Colin Wallis, FRCPCH, Principal Investigator
Caro Minasian, Sub-Investigator
Andrew Bush, FRCPCH, Principal Investigator, Royal Brompton and Harefiled NHS Trust
Colin Wallis, FRCPCH, Principal Investigator, Great Ormond Street Hospital for Children
More Information
Publications
Suri R, Metcalfe C, Lees B, Grieve R, Flather M, Normand C, Thompson S, Bush A, Wallis C. Comparison of hypertonic saline and alternate-day or daily recombinant human deoxyribonuclease in children with cystic fibrosis: a randomised trial. Lancet. 2001 Oct 20;358(9290):1316-21.
Robinson M, Daviskas E, Eberl S, Baker J, Chan HK, Anderson SD, Bye PT. The effect of inhaled mannitol on bronchial mucus clearance in cystic fibrosis patients: a pilot study. Eur Respir J. 1999 Sep;14(3):678-85.
Daviskas E, Anderson SD, Brannan JD, Chan HK, Eberl S, Bautovich G. Inhalation of dry-powder mannitol increases mucociliary clearance. Eur Respir J. 1997 Nov;10(11):2449-54.
Daviskas E, Anderson SD, Eberl S, Chan HK, Bautovich G. Inhalation of dry powder mannitol improves clearance of mucus in patients with bronchiectasis. Am J Respir Crit Care Med. 1999 Jun;159(6):1843-8.
Daviskas E, Anderson SD, Eberl S, Chan HK, Young IH. The 24-h effect of mannitol on the clearance of mucus in patients with bronchiectasis. Chest. 2001 Feb;119(2):414-21.
Daviskas E, Anderson SD, Gomes K, Briffa P, Cochrane B, Chan HK, Young IH, Rubin BK. Inhaled mannitol for the treatment of mucociliary dysfunction in patients with bronchiectasis: effect on lung function, health status and sputum. Respirology. 2005 Jan;10(1):46-56.
Record last reviewed: June 2005
Last Updated: July 2, 2005
Record first received: July 2, 2005
ClinicalTrials.gov Identifier: NCT00117208
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-07-05
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