Skip to main content
OpenTrials
Completed

NCT Number: NCT00546663

Tolerability of Inhaled Hypertonic Saline in Infants With Cystic Fibrosis

This is an open-label pilot study of the safety and tolerability of 7% hypertonic saline inhaled twice daily for 14 days in infants with CF, 12 to 30 months of age.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

12 month–30 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children, Toronto, Ontario, Canada

Loading trial locations.

About this study

The efficacy and safety of hypertonic saline (HS) in CF patients over 6 years of age has been demonstrated in clinical trials of 2 to 48 weeks' duration. Based on these results, a large randomized, placebo-controlled trial of the efficacy and safety of 7% HS administered twice daily for 48 weeks to infants with CF, 4 to 15 months of age at enrollment, is planned (the Infant Study of Inhaled Saline (ISIS) trial). It is anticipated that 150 infants at up to 16 sites will be enrolled in the ISIS trial.

To date, the only evaluations of the safety of HS in infants with CF have been small single-dose studies. There has been no evaluation of the tolerability of chronic HS administration. The goal of this study is to assess the safety and tolerability of exposure to 14 days of 7% HS administered twice daily in infants with CF, prior to enrolling subjects in the planned large, randomized, controlled trial. Conduct of this study will provide evidence for the tolerability of chronic HS administration in infants with CF and estimates of the proportion of infants who do not tolerate chronic HS treatment. The results will be used to establish the appropriate measures of tolerability at enrollment in the ISIS trial, and to refine sample size estimates to account for withdrawal due to intolerance of HS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of CF as defined by one 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 by parent or legal guardian
  • 12-30 months of age at enrollment

Exclusion criteria

  • Wheezing at the baseline evaluation at the enrollment visit
  • Oxygen saturation < 95 % at the baseline evaluation at the enrollment visit
  • Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate, or new rhinorrhea, nasal congestion or rhinorrhea, with onset in the week preceding the enrollment visit
  • Investigational drug use within 30 days prior to the enrollment visit
  • Known intolerance of albuterol
  • Current enrollment in a therapeutic clinical trial
  • Condition or situation which, in the opinion of the investigator, would affect the ability of the patient or family to complete study procedures

Treatment and study plan

inhaled 7% hypertonic saline (HS)

Drug

7% hypertonic saline administered twice daily for 14 days by nebulization.

A Pari Sprint Junior nebulizer equipped with a Pari Baby face mask and a Pari Proneb compressor will be used to administer the HS (PARI Respiratory Equipment, Inc., Midlothian, VA).

To minimize the risk of cough and bronchospasm with HS inhalation, infants will be pre-treated prior to each dose of HS with albuterol by metered dose inhaler

Other names: Hyper-Sal™, inhaled saline

Primary outcomes

  1. The proportion of infants who are intolerant of single and repeated doses of HS according to protocol-defined criteria

    Time frame: At the enrollment visit, during the period of home administration (Days 0 to 14), and at the final study visit.

Secondary outcomes

  1. New or increased cough, increased qualitative breathing rate, new or increased noisy breathing, or new or increased emesis at home as noted by parents on the daily symptom report

    Time frame: During the period of home administration (Days 0 to 14)

  2. Change in respiratory rate, oxygen saturation, or cough frequency between the baseline measurement and measurements obtained after HS administration

    Time frame: At the enrollment visit

  3. Change in respiratory rate, oxygen saturation, or cough frequency between the baseline value at the enrollment visit and the value at the final study visit

    Time frame: Over two weeks of study participation

  4. Unanticipated adverse events

    Time frame: Over two weeks of study participation

  5. Adherence, as measured by (1) the number of doses of HS administered per the home symptom report and (2) returned study drug vials

    Time frame: During the period of home administration (Days 0 to 14)

Sponsors and collaborators

Lead sponsor

CF Therapeutics Development Network Coordinating Center

Network

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

A Pilot Study to Evaluate the Tolerability of Inhaled 7% Hypertonic Saline in Infants With Cystic Fibrosis

Acronym: ISIS Pilot

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 19, 2007
Registry last updated
Aug 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.