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Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00117208
Recruitment Status : Completed
First Posted : July 4, 2005
Last Update Posted : February 2, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: mannitol Drug: mannitol + pulmozyme Drug: Dornase alpha Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis
Study Start Date : November 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Experimental: 1 Drug: mannitol
400mg BD for 12 weeks

Active Comparator: 2
DNase daily for 12 weeks
Drug: Dornase alpha
2.5mg daily for 2 weeks
Other Name: rhDNase, pulmozyme

Drug: mannitol + pulmozyme

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00117208

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United Kingdom
Great Ormond Hospital for Children
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom
Sponsors and Collaborators
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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
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00117208    
Other Study ID Numbers: DPM-CF-203
First Posted: July 4, 2005    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: January 2010
Keywords provided by Pharmaxis:
cystic fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs