Tolerability of Inhaled Hypertonic Saline in Infants With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00546663
• Date of registration: 17/10/2007
• Primary sponsor: CF Therapeutics Development Network Coordinating Center
• Public title: Tolerability of Inhaled Hypertonic Saline in Infants With Cystic Fibrosis ISIS Pilot
• Scientific title: A Pilot Study to Evaluate the Tolerability of Inhaled 7% Hypertonic Saline in Infants With Cystic Fibrosis
• Date of first enrolment: September 2007
• Target sample size: 19
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00546663
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada, United States

Contacts

• Name: Margaret Rosenfeld, MD, MPH
• Affiliation: Seattle Children's Hospital

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

• Name: Stephanie Davis, MD
• Affiliation: University of North Carolina

Key inclusion & exclusion criteria

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



Age minimum: 12 Months
Age maximum: 30 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: inhaled 7% hypertonic saline (HS)

Primary Outcome(s)

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 Outcome(s)

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)]

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]

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]

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)]

Unanticipated adverse events [Time Frame: Over two weeks of study participation]

Secondary ID(s)

ISIS001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation