A Phase 2 interventional study of Hypertonic Saline 7% and Isotonic Saline 0.9% (Placebo) in Cystic Fibrosis, sponsored by The Hospital for Sick Children. Completed at 2 sites in Canada. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2015-05-22.
Sponsored by The Hospital for Sick Children · Phase 2, Interventional, and Treatment
The Lung Clearance Index (LCI) is a non invasive measure of lung function that is more sensitive than FEV1. It can be used to measure lung function in children younger than 6 years of age. Therefore, it has a future role in assessing novel therapeutics in the Cystic Fibrosis (CF) population. As such, determining if it can be used as a short term pharmacodynamic biomarker is paramount.
Inhaled Hypertonic saline (7%) is a treatment intervention for Cystic Fibrosis patients and has previously been shown to improve lung function and decrease the number of pulmonary exacerbations. The Cystic Fibrosis Transmembrane Regulator Gene (CFTR) protein is essential for maintaining fluid and electrolyte homeostasis in the lung and CFTR defects cause depletion of the periciliary liquid layer which results in impaired mucociliary clearance. Inhaled hypertonic saline (7%) acts as an osmotic agent in the lungs; it repletes the airway surface liquid (ASL) and improves mucociliary clearance.
In addition, we have recently demonstrated that the Lung Clearance Index (LCI) is also a responsive outcome measure. In an intervention study in which patients were treated with hypertonic saline inhalation twice daily for 28 days, LCI but not FEV1 significantly improved in 17 pediatric Cystic Fibrosis (CF) patients with mild lung disease. In this study, LCI was more sensitive to a change in response to treatment than spirometry in a small number of patients. However, it still remains unknown if the LCI will be able to detect a treatment effect on a shorter time scale after an intervention. Its use as a short-term pharmacodynamic biomarker in CF patients remains unknown. The ability of the LCI to detect treatment effects within hours after an intervention would be invaluable to the development of new therapeutic interventions for CF patients.
1,605 studies on the registry are indexed under Cystic Fibrosis; 196 are open to participants now.
This study's planned enrollment of 24 is below the median of 36 across 1,051 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →The Hospital for Sick Children is the lead sponsor of 577 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The treatment intervention is 1 inhalation of 7% hypertonic saline (4ml)
Drug: Hypertonic Saline 7%
The placebo intervention is 1 inhalation of 0.9% isotonic saline
Drug: Isotonic Saline 0.9% (Placebo)
PARI Hyper-Sal™ Sodium Chloride Solution - 7%
Lung Clearance Index
The change in the Lung Clearance Index as measured by nitrogen washout between baseline and 24 hours after each inhalation of Hypertonic Saline (7%) and Isotonic Saline (0.9%)
Time frame: Baseline to 24 hrs post dose
Pulmonary Function Testing
Forced Expiratory Volume in one second (FEV1) % predicted, Forced Expiratory Vital Capacity (FVC) % predicted and Forced Expiratory Flow rate (FEF) 25-75 % predicted will be measured using spirometry.
Time frame: Baseline, 1,2,4 and 24hrs post-dose
Lung Clearance Index measured using Mass Spectroscopy
The multiple breath washout will be performed in the classical method using a mass spectroscopy (MS): each test consists of two phases: a wash-in phase and washout phase using an inert dry gas mixture containing 4% Sulfur hexafluoride (SF6), 4% He, 21% oxygen and balance nitrogen.
Time frame: Baseline, 1,2,4 and 24 hrs post dose
Lung Clearance Index measured using Nitrogen Washout
The change in the Lung Clearance Index as measured by nitrogen washout between baseline and 1,2 and 4 hours after each inhalation of Hypertonic Saline (7%) and Isotonic Saline (0.9%)
Time frame: Baseline, 1,2, 4hrs post dose
The record gives a start of Nov 2011, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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