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

NCT00271310 | Completed Phase 3

• 2 other identifiers: X95-0118B97/31391
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Lung function (FEV1, FVC, FEF25-75)

Secondary Outcomes (9)

• Pulmonary exacerbations (therapy-defined and symptom-defined)(number and duration)

• Total antibiotic-days

• Absenteeism

• Weight / body mass index

• Quality of life

Interventions

hypertonic saline DRUG

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Prince Alfred Hospital, Sydney, Australia: lead
• Cystic Fibrosis Foundation: collaborator
• National Health and Medical Research Council, Australia: collaborator
• Cystic Fibrosis Trust: collaborator

Related Publications (2)

• 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.

  PMID: 16421364 RESULT

• Wark P, McDonald VM, Smith S. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD001506. doi: 10.1002/14651858.CD001506.pub5.

  PMID: 37319354 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Peter T P Bye, PhD

  Royal Prince Alfred Hospital, Sydney, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: December 30, 2005
• Study Start: September 1, 2000
• Study Completion: November 1, 2003
• Last Updated: October 9, 2006

Record last verified: 2006-10