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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00635141
• Date of registration: 04/03/2008
• Prospective Registration: No
• Primary sponsor: The Hospital for Sick Children
• Public title: The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis
• Scientific title: The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic Fibrosis
• Date of first enrolment: March 2008
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00635141
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Canada

Contacts

• Name: Felix Ratjen, MD
• Affiliation: The Hospital for Sick Children

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: hypertonic saline (7 %) and isotonic saline (0.9%)

Primary Outcome(s)

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]

Secondary Outcome(s)

Change in FEV1 % predicted [Time Frame: Duration of patient's involvement in study]

Change in FVC (forced vital capacity) % predicted [Time Frame: Duration of patient's involvement in study]

Change in FEF25-75% (forced expiratory flow between 25 and 75 % of vital capacity) predicted [Time Frame: Duration of patient's involvement in study]

Secondary ID(s)

1000011193

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Canadian Cystic Fibrosis Foundation