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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
hypertonic saline
Sponsored by
Royal Prince Alfred Hospital, Sydney, Australia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    December 29, 2005
    Last Updated
    October 6, 2006
    Sponsor
    Royal Prince Alfred Hospital, Sydney, Australia
    Collaborators
    Cystic Fibrosis Foundation, National Health and Medical Research Council, Australia, Cystic Fibrosis Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00271310
    Brief Title
    The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
    Official Title
    The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2003 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Royal Prince Alfred Hospital, Sydney, Australia
    Collaborators
    Cystic Fibrosis Foundation, National Health and Medical Research Council, Australia, Cystic Fibrosis Trust

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    164 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    hypertonic saline
    Primary Outcome Measure Information:
    Title
    Lung function (FEV1, FVC, FEF25-75)
    Secondary Outcome Measure Information:
    Title
    Pulmonary exacerbations (therapy-defined and symptom-defined)(number and duration)
    Title
    Total antibiotic-days
    Title
    Absenteeism
    Title
    Weight / body mass index
    Title
    Quality of life
    Title
    Quantitative microbiology of sputum
    Title
    Aquisition and loss of organisms from sputum
    Title
    Cyotkine assays in sputum
    Title
    Adverse events

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter T P Bye, PhD
    Organizational Affiliation
    Royal Prince Alfred Hospital, Sydney, Australia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16421364
    Citation
    Elkins MR, Robinson M, Rose BR, Harbour C, Moriarty CP, Marks GB, Belousova EG, Xuan W, Bye PT; National Hypertonic Saline in Cystic Fibrosis (NHSCF) Study Group. A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med. 2006 Jan 19;354(3):229-40. doi: 10.1056/NEJMoa043900.
    Results Reference
    result

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

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