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The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00271310
Recruitment Status : Completed
First Posted : December 30, 2005
Last Update Posted : October 9, 2006
Cystic Fibrosis Foundation
National Health and Medical Research Council, Australia
Cystic Fibrosis Trust
Information provided by:
Royal Prince Alfred Hospital, Sydney, Australia

Brief Summary:
The effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on lung function, incidence of respiratory tract infections, quality of life, quantitative microbiology and sputum cytokine profile. The hypothesis is that regular inhalation of nebulised hypertonic saline will have a beneficial effect on lung function and other clinical outcomes with no adverse effects on infection and inflammation in adults and children with cystic fibrosis.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: hypertonic saline Phase 3

Detailed Description:
The study intervention is nebulised hypertonic (7%) saline (Active) or nebulised normal (0.9%) saline (Control) twice per day for 336 days. At a screening visit, subjects will complete quality of life questionnaires, be questioned regarding their medical history, undergo physical examination and spirometry, and will be requested to provide a sputum sample. The subject is then supervised taking their first dose to ensure the correct procedure is used and there are no adverse effects. The subject then commences taking the trial solution at home, and once a week completes a diary card to monitor factors such as respiratory tract infections and medication use. Subsequent visits are scheduled at Days 28, 84, 168, 252, 334, and 336, at which the same investigation are performed as at the screening visit.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
Study Start Date : September 2000
Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Primary Outcome Measures :
  1. Lung function (FEV1, FVC, FEF25-75)

Secondary Outcome Measures :
  1. Pulmonary exacerbations (therapy-defined and symptom-defined)(number and duration)
  2. Total antibiotic-days
  3. Absenteeism
  4. Weight / body mass index
  5. Quality of life
  6. Quantitative microbiology of sputum
  7. Aquisition and loss of organisms from sputum
  8. Cyotkine assays in sputum
  9. Adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of CF (sweat tests/genotype)
  • The subject, or their legal guardian for children under 18 years old, must provide written informed consent.
  • The subject must be in stable clinical condition at the time of and for a period of 14 days prior to their recruitment into the study.
  • Age > 6 years old
  • FEV1 > 40% predicted for height, age and gender
  • Proven or anticipated compliance with therapy or study protocol
  • Regular attendee at a Cystic Fibrosis Clinic (> 2 visits per year)
  • Able to reproducibly perform lung function tests (spirometry)
  • Relatively stable nutritional status (< 2 kg weight loss in last 6 months and < 5 kg weight loss in last year)
  • Known to have "normal" (for CF subject) laboratory tests - haematology, biochemistry, immunology, coagulation, etc.

Exclusion Criteria:

  • Requiring home oxygen (pO2 <55mmHg or pCO2 >50mmHg) or assisted ventilation.
  • Considered "terminally ill" or listed for transplantation (either lung or liver). Subjects that are listed for transplant after being enrolled in the trial are eligible to continue in the trial.
  • Subjects colonised with Burkholderia cepacia. However, if a subject becomes colonised with B. cepacia during the trial, they should continue in the trial. Subjects should be considered to be B. cepacia positive if they have had even a single lifetime isolate. In these subjects, spirometry should be measured on a dedicated spirometer.
  • Cigarette smoker.
  • Exposure to investigational drugs within the past 30 days.
  • Major haemoptysis (> 60 mL in a single episode) within the last twelve months.
  • Concurrent illnesses eg. cor pulmonale, clinically significant liver disease (portal hypertension, varices).
  • Known allergy to quinine sulphate, Glucose 6-phosphate dehydrogenase deficiency.
  • Immune thrombocytopaenic purpura.
  • Pregnant or lactating females.
  • At risk females unwilling to use appropriate contraception to prevent pregnancy for the duration of their enrolment in the study.

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 ClinicalTrials.gov identifier (NCT number): NCT00271310

Sponsors and Collaborators
Royal Prince Alfred Hospital, Sydney, Australia
Cystic Fibrosis Foundation
National Health and Medical Research Council, Australia
Cystic Fibrosis Trust
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Principal Investigator: Peter T P Bye, PhD Royal Prince Alfred Hospital, Sydney, Australia
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00271310    
Other Study ID Numbers: X95-0118B
First Posted: December 30, 2005    Key Record Dates
Last Update Posted: October 9, 2006
Last Verified: October 2006
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