The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635141
• Other study ID #: 1000011193
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2008
• Last updated: August 30, 2013
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: August 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Cystic Fibrosis Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Amin R, Subbarao P, Jabar A, Balkovec S, Jensen R, Kerrigan S, Gustafsson P, Ratjen F. Hypertonic saline improves the LCI in paediatric patients with CF with normal lung function. Thorax. 2010 May;65(5):379-83. doi: 10.1136/thx.2009.125831. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LCI from baseline to end of treatment in hypertonic saline treated patients versus patients receiving placebo (isotonic saline)		Duration of patient's involvement in study	No
Secondary	Change in FEV1 % predicted		Duration of patient's involvement in study	No
Secondary	Change in FVC (forced vital capacity) % predicted		Duration of patient's involvement in study	No
Secondary	Change in FEF25-75% (forced expiratory flow between 25 and 75 % of vital capacity) predicted		Duration of patient's involvement in study	No