The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis - Full Text View

Sponsors and Collaborators:	The Hospital for Sick Children Canadian Cystic Fibrosis Foundation
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00635141

Purpose

This study is examining the effect of hypertonic saline compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: hypertonic saline (7 %) and isotonic saline (0.9%)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With 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:

Change in LCI from baseline to end of treatment in hypertonic saline treated patients versus patients receiving placebo (isotonic saline) [ Time Frame: Duration of patient's involvement in study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in FEV1 % predicted [ Time Frame: Duration of patient's involvement in study ] [ Designated as safety issue: No ]
Change in FVC (forced vital capacity) % predicted [ Time Frame: Duration of patient's involvement in study ] [ Designated as safety issue: No ]
Change in FEF25-75% (forced expiratory flow between 25 and 75 % of vital capacity) predicted [ Time Frame: Duration of patient's involvement in study ] [ Designated as safety issue: No ]

Estimated Enrollment:	21
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: hypertonic saline (7 %) and isotonic saline (0.9%) Patients in study arm 1 will receive hypertonic saline (7 %) during the first phase of the study and will crossover to placebo (0.9% isotonic saline) during the second phase. Both drugs will be administered via PARI LC® Star reusable nebulizer.
2: Experimental	Drug: hypertonic saline (7 %) and isotonic saline (0.9%) Patients in study arm 2 will receive placebo (0.9% isotonic saline) during the first phase of the study and will crossover to hypertonic saline (7 %) during the second phase. Both drugs will be administered via PARI LC® Star reusable nebulizer.

Detailed Description:

The life expectancy of patients with Cystic Fibrosis (CF) has greatly increased over time due to improved clinical care. While this is certainly beneficial to CF patients, the overall stability in lung function has made it more difficult to assess the effect of therapeutic interventions. Currently, FEV1 (forced expiratory volume in

1 second) remains the primary outcome measure for most clinical trials, but many CF patients have normal pulmonary function and the annual rate of decline is now less than 2% in large specialized centres. Therefore, additional parameters are needed that are more sensitive parameters to define abnormalities in CF patients and be used in therapeutic trials.

One such promising parameter is the Lung Clearance Index (LCI). The LCI is a test to quantify ventilation inhomogeneity by assessing the washout of an inhaled inert gas. Abnormalities in gas clearance from the lung are largely due to retention of inhaled gases due to mucous obstruction in the lower airways.

Interventions that improve mucus accumulation are expected to improve the LCI. Hypertonic saline has been shown to increase airway surface liquid (ASL), mucociliary clearance and pulmonary function. Therefore, this study will examine the effect of hypertonic saline compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
Informed consent and verbal assent (as appropriate) provided by the subject's parent or legal guardian and the subject
6-18 years of age at enrolment and able to perform reproducible spirometry
Clinically stable at enrolment
FEV1 % predicted ≥ 80 % as calculated by the Wang reference equations
Ability to comply with medication use, study visits and study procedures

Exclusion Criteria:

Respiratory culture positive for NTM or B. cepacia complex within past year or screening
Use of intravenous antibiotics or oral quinolones within 14 days of screening
Investigational drug use within 30 days of screening
Physical findings at screening that would compromise the safety of the participant or the quality of the study data

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635141

Contacts

Contact: Felix Ratjen, MD

(416)813-6167

felix.ratjen@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada
Principal Investigator: Felix Ratjen, MD
Sub-Investigator: PJ Subbarao, MD
Sub-Investigator: Reshma Amin, MD

Sponsors and Collaborators

The Hospital for Sick Children

Canadian Cystic Fibrosis Foundation

Investigators

Principal Investigator:

Felix Ratjen, MD

The Hospital for Sick Children

More Information

No publications provided

Responsible Party:	The Hospital for Sick Children ( Felix Ratjen/Principal Investigator )
Study ID Numbers:	1000011193
Study First Received:	March 4, 2008
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00635141 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

Cystic Fibrosis
Lung Clearance Index
Hypertonic Saline
Pediatrics

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

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

ClinicalTrials.gov processed this record on September 10, 2009