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

NCT00721071 | Completed Phase 2

• 1 other identifier: 1000009154
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

Pediatrics; Cystic Fibrosis; Hypertonic Saline; Induced Sputum; Expectorated Sputum

Outcome Measures

Primary Outcomes (1)

• Additional positive bacterial culture yield post IS technique for known and emerging CF pathogens over conventional methods of bacterial culturing (ES and TS).

  60 minutes; for subgroup, this will be repeated a second time after 14 days.

Secondary Outcomes (3)

• Inflammatory profile as measured by relative neutrophil count and IL-8 concentration in the IS

  60 minutes; for subgroup, this will be repeated a second time after 14 days.

• Bacterial colony counts

  60 minutes; for subgroup, this will be repeated a second time after 14 days.

• Frequency of change in clinical management based on results from IS

  60 minutes; for subgroup, this will be repeated a second time after 14 days.

Study Arms (1)

1

EXPERIMENTAL

Drug: Hypertonic Saline

Interventions

Hypertonic Saline DRUG

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.

1

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Al-Saleh S, Dell SD, Grasemann H, Yau YC, Waters V, Martin S, Ratjen F. Sputum induction in routine clinical care of children with cystic fibrosis. J Pediatr. 2010 Dec;157(6):1006-1011.e1. doi: 10.1016/j.jpeds.2010.06.001. Epub 2010 Jul 14.

  PMID: 20630539 RESULT

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

• Felix Ratjen, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, Respiratory Medicine

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: December 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 2, 2013

Record last verified: 2013-08

Locations

CA (1)