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

NCT00635141 | Completed Phase 3

• 1 other identifier: 1000011193
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Lung Clearance Index; Hypertonic Saline; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in FEV1 % predicted

  Duration of patient's involvement in study

• Change in FVC (forced vital capacity) % predicted

  Duration of patient's involvement in study

• Change in FEF25-75% (forced expiratory flow between 25 and 75 % of vital capacity) predicted

  Duration of patient's involvement in study

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

Interventions

hypertonic saline (7 %) and isotonic saline (0.9%) DRUG

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.

1

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Cystic Fibrosis Foundation: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Related Publications (2)

• 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.

  PMID: 20435858 RESULT

• Wark P, McDonald VM, Smith S. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD001506. doi: 10.1002/14651858.CD001506.pub5.

  PMID: 37319354 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Saline Solution, Hypertonic; Sodium Chloride

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Felix Ratjen, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, Respiratory Medicine

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 13, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 2, 2013

Record last verified: 2013-08

Locations

CA (1)