NCT02276898

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2011

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

2.8 years

First QC Date

October 22, 2014

Last Update Submit

May 20, 2015

Conditions

Cystic Fibrosis

Keywords

pediatriclung clearance indexMultiple Breath WashoutHypertonic Saline

Outcome Measures

Primary Outcomes (1)

  • 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%)

    Baseline to 24 hrs post dose

Secondary Outcomes (3)

  • Pulmonary Function Testing

    Baseline, 1,2,4 and 24hrs post-dose

  • Lung Clearance Index measured using Mass Spectroscopy

    Baseline, 1,2,4 and 24 hrs post dose

  • Lung Clearance Index measured using Nitrogen Washout

    Baseline, 1,2, 4hrs post dose

Study Arms (2)

Hypertonic Saline

ACTIVE COMPARATOR

The treatment intervention is 1 inhalation of 7% hypertonic saline (4ml)

Drug: Hypertonic Saline 7%

Isotonic Saline

PLACEBO COMPARATOR

The placebo intervention is 1 inhalation of 0.9% isotonic saline

Drug: Isotonic Saline 0.9% (Placebo)

Interventions

Hypertonic Saline 7%DRUG

PARI Hyper-Sal™ Sodium Chloride Solution - 7%

Hypertonic Saline
Isotonic Saline 0.9% (Placebo)DRUG
Isotonic Saline

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • At least six years of age at enrolment
  • Able to perform reproducible spirometry meeting American Thoracic Society standards
  • Pre-bronchodilator FEV1 % predicted \> or equal to 40 % predicted
  • Ability to perform a reproducible LCI maneuver at screening

You may not qualify if:

  • Known respiratory culture positive for Burkholderia cepacia
  • Previous lung transplantation
  • Use of intravenous antibiotics within 14 days of screening
  • Use of oral antibiotics including prophylactic antibiotics (e.g., augmentin, tetracycline, cloxacillin, cephalosporins, septra, bactrim) within 14 days of screening
  • Initiation of a new maintenance (e.g high dose ibuprofen, Pulmozyme®, aerosolized antibiotics) within 14 days of screening
  • Use of systemic corticosteroids within 14 days of screening
  • Investigational drug use within 30 days of screening
  • Use of hypertonic saline (7%) \< 4 weeks before screening or outside of the study protocol
  • Participation in any therapeutic clinical study \<4 weeks or, 5 half-lives, whichever is longer, before screening
  • Smoking \< 3 months before screening
  • Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

St. Michaels Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Reshma Amin, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Respirologist

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 28, 2014

Study Start

November 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

CA(2)