Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis - Full Text View

Sponsored by:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00721071

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 II

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Diagnostic Utility of Induced Sputum Using Hypertonic Saline to Evaluate Airway Infection and Inflammation in Cystic Fibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

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 ]

Estimated Enrollment:	150
Study Start Date:	September 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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:

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

Additional inclusion criteria for sub-sample undergoing antibiotic therapy:

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

Exclusion Criteria:

Acute respiratory distress or hypoxia (oxygen saturation <92% at room air)
New onset of wheezing
Previous history of intolerance of inhalation of HS

Contacts and Locations

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

Contacts

Contact: Felix Ratjen, MD

416-813-6167

felix.ratjen@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Felix Ratjen, MD 416 813 6167 felix.ratjen@sickkids.ca
Principal Investigator: Felix Ratjen, MD
Sub-Investigator: Sharon Dell, MD
Sub-Investigator: Hartmut Grasemann, MD
Sub-Investigator: Suhail Al-Saleh, MD

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator:

Felix Ratjen, MD

The Hospital for Sick Children, Toronto Canada

More Information

No publications provided

Responsible Party:	The Hospital for Sick Children ( Felix Ratjen/Principal Investigator )
Study ID Numbers:	1000009154
Study First Received:	July 21, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00721071 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

Pediatrics
Cystic Fibrosis
Hypertonic Saline
Induced Sputum
Expectorated Sputum

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Bronchodilator Agents
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Inflammation

ClinicalTrials.gov processed this record on September 09, 2009