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

This study has been completed.
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
National Health and Medical Research Council, Australia
Cystic Fibrosis Trust
Information provided by:
Royal Prince Alfred Hospital, Sydney, Australia
ClinicalTrials.gov Identifier:
NCT00271310
First received: December 29, 2005
Last updated: October 6, 2006
Last verified: October 2006
History of Changes
  Purpose

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 Intervention Phase
Cystic Fibrosis
 Drug: hypertonic saline
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Royal Prince Alfred Hospital, Sydney, Australia:

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

Secondary Outcome Measures:
  • Pulmonary exacerbations (therapy-defined and symptom-defined)(number and duration)
  • Total antibiotic-days
  • Absenteeism
  • Weight / body mass index
  • Quality of life
  • Quantitative microbiology of sputum
  • Aquisition and loss of organisms from sputum
  • Cyotkine assays in sputum
  • Adverse events

Estimated Enrollment: 164
Study Start Date: September 2000
Estimated Study Completion Date: November 2003
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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271310

Sponsors and Collaborators
Royal Prince Alfred Hospital, Sydney, Australia
Cystic Fibrosis Foundation
National Health and Medical Research Council, Australia
Cystic Fibrosis Trust
Investigators
Principal Investigator: Peter T P Bye, PhD Royal Prince Alfred Hospital, Sydney, Australia
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00271310     History of Changes
Other Study ID Numbers: X95-0118B, 97/31391
Study First Received: December 29, 2005
Last Updated: October 6, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013