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A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis

Information source: Pharmaxis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Inhaled mannitol (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pharmaxis

Official(s) and/or principal investigator(s):
Brett Charlton, Study Director, Affiliation: Pharmaxis

Summary

Cystic fibrosis is the most frequent lethal genetic disease of childhood. Causes disruption of glandular function of the pancreas, intestine, liver, lungs (causing chronic lung infection with emphysema), sweat glands and reproductive organs. We know that many CF patients die of lung failure, brought about in part by repeated lung infections caused by thick, sticky mucus that cannot be readily cleared from the lung. Inhaled mannitol is an osmotic agent that has been investigated in a number of small studies that have examined mucociliary clearance, quality of life and lung function in CF and bronchiectasis. The promising results of these studies warrant futher investigation. The aim of this study is to assess the safety and efficacy of inhaled mannitol when administered twice a day over two weeks in CF.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: FEV1

Secondary outcome:

Other measures of lung function

Quality of life

Sputum microbiology

Sputum rheology

Safety

Eligibility

Minimum age: 8 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Confirmed diagnosis of cystic fibrosis (sweat test/genotype) 2. Aged 8 years or older 3. Have FEV1 between 40% and 80% of predicted for height, age and gender OR a decrease in FEV1 of 20% or more than that recorded 6-12 months previously. 4. As determined by the investigator, are capable and willing to

- Use the study diary as required for this protocol

- Able to perform all of the techniques necessary to measure lung function

- Able to administer the dry powder mannitol

5. Are capable of and have given informed consent 6. Clinically stable at study entry Exclusion Criteria: 1. Investigators, site personnel directly affiliated with this study, and their immediate families. 2. Subjects under the age of 8 years. 3. Subjects with currently active asthma 4. Subjects using hypertonic saline treatment in the last 2 weeks 5. Considered "terminally ill" or listed for transplantation 6. Requiring home oxygen or assisted ventilation 7. Colonisation with Burkholderia cepacia 8. Significant episode of hemoptysis (>60 mls) in the previous 12 months 9. Myocardial Infarction in the six months prior to enrolment. 10. Cerebral Vascular Accident in the six months prior to enrolment. 11. Ocular surgery in the three months prior to enrolment. 12. Abdominal surgery in the three months prior to enrolment. 13. Subjects who are breast feeding or pregnant. 14. Female subjects of reproductive capability, not using a reliable form of contraception 15. Inability to obtain informed consent from the subject or subject's authorised representative. 16. Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry. 17. Known intolerance to mannitol or beta2 agonists.

18. Uncontrolled hypertension - systolic BP > 160 and or diastoli

Locations and Contacts

Childrens Hospital at Westmead, Sydney, New South Wales 2145, Australia

Royal Prince Alfred Hospital, Sydney, New South Wales 2050, Australia

Greenlane Hospital, Auckland, North Island, New Zealand

Prince Charles Hospital, Brisbane, Queensland, Australia

Royal Children's Hospital, Melbourne, Victoria 3052, Australia

The Alfred Hospital, Melbourne, Victoria 3181, Australia

Princess Margaret Hospital for Children, Perth, Western Australia 6840, Australia

Sir Charles Gairdner, Perth, Western Australia, Australia

Additional Information

Starting date: March 2004
Last updated: January 31, 2010

Page last updated: August 23, 2015

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