Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felix Ratjen, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00721071
First received: July 21, 2008
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

The objective of the study is to evaluate the clinical utility and the feasibility, in an outpatient setting, of sputum induction using hypertonic saline. This study will also study pilot techniques on a sub using a sub-sample to assess the lower airway inflammatory cells and markers in relation to new emerging organisms in cystic fibrosis (CF) and antibiotic therapy in CF.


Condition Intervention Phase
Cystic Fibrosis
Drug: Hypertonic Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Utility of Induced Sputum Using Hypertonic Saline to Evaluate Airway Infection and Inflammation in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Additional positive bacterial culture yield post IS technique for known and emerging CF pathogens over conventional methods of bacterial culturing (ES and TS). [ Time Frame: 60 minutes; for subgroup, this will be repeated a second time after 14 days. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory profile as measured by relative neutrophil count and IL-8 concentration in the IS [ Time Frame: 60 minutes; for subgroup, this will be repeated a second time after 14 days. ] [ Designated as safety issue: No ]
  • Bacterial colony counts [ Time Frame: 60 minutes; for subgroup, this will be repeated a second time after 14 days. ] [ Designated as safety issue: No ]
  • Frequency of change in clinical management based on results from IS [ Time Frame: 60 minutes; for subgroup, this will be repeated a second time after 14 days. ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: December 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Hypertonic Saline
After each subject has performed post-bronchodilator spirometry, he/she will inhale increasing concentrations of 3, 4, and 5% of hypertonic saline for 7 minutes each for 3 cycles until expectorating a sufficient sputum sample.

Detailed Description:

Chronic airway infection, mainly by Staphylococcus aureus (SA) and Pseudomonas aeruginosa (PA), is a major cause of morbidity and mortality in patients with cystic fibrosis (CF). Isolation of organisms from the respiratory tract is important to optimize treatment. The current recommended methods for bacterial evaluation are bronchoalveolar lavage (BAL) and expectorated sputum (ES) analysis. However, a significant proportion of young CF patients cannot produce sputum spontaneously. The method used most frequently therefore is to isolate respiratory organisms is to perform throat swabs (TS) which have poor sensitivity and specificity in the evaluation of respiratory pathogens in CF patients.

Induced sputum (IS) using hypertonic saline has been used in a limited number of studies to evaluate respiratory organisms in CF patients. These studies have reported that IS may be a useful non-invasive diagnostic test to increase the yield of detection of respiratory pathogens.

Beside its use as a diagnostic test to identify bacterial pathogens induced sputum has been used to assess lower airway inflammation in CF. While numerous studies have clarified the role of S. aureus and P. aeruginosa in CF lung disease, the role of other emerging bacteria such as Stenotrophomonas maltophilia (SM) and Achromobacter xylosoxidans (AX) species remains largely unclear. IS offers the potential to possibly differentiate between colonisation and infection for the emerging pathogens and to help clarify their role in CF lung disease.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children diagnosed with CF (by sweat chloride ≥60 and/or genetic testing)
  2. Children ages between 6-18 years
  3. Ability to perform pulmonary function tests
  4. FEV1 ≥ 30% predicted18.

Additional inclusion criteria for sub-sample undergoing antibiotic therapy:

  1. Above criteria
  2. Admitted to hospital for i.v. antibiotic therapy

Exclusion Criteria:

  1. Acute respiratory distress or hypoxia (oxygen saturation <92% at room air)
  2. New onset of wheezing
  3. Previous history of intolerance of inhalation of HS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721071

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Felix Ratjen, MD The Hospital for Sick Children, Toronto Canada
  More Information

Publications:
Responsible Party: Felix Ratjen, Division Head, Respiratory Medicine, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00721071     History of Changes
Other Study ID Numbers: 1000009154
Study First Received: July 21, 2008
Last Updated: August 30, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Pediatrics
Cystic Fibrosis
Hypertonic Saline
Induced Sputum
Expectorated Sputum

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

ClinicalTrials.gov processed this record on October 21, 2014