NCT00546663

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Shorter than P25 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

August 24, 2011

Status Verified

August 1, 2011

Enrollment Period

8 months

First QC Date

October 17, 2007

Last Update Submit

August 22, 2011

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis, hypertonic saline

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (5)

  • 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

    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

    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

    Over two weeks of study participation

  • Unanticipated adverse events

    Over two weeks of study participation

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

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

Study Arms (1)

Open-label

EXPERIMENTAL
Drug: inhaled 7% hypertonic saline (HS)

Interventions

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

Also known as: Hyper-Sal™, inhaled saline
Open-label

Eligibility Criteria

Age12 Months - 30 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • months of age at enrollment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of North Carolina

Chapel Hill, North Carolina, 27599-7248, United States

Location

Children's Hospital and Regional Medical Center

Seattle, Washington, 98105, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

InhalationSaline Solution, Hypertonic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaHypertonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Margaret Rosenfeld, MD, MPH

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Stephanie Davis, MD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

  • Felix Ratjen, MD, PhD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 19, 2007

Study Start

September 1, 2007

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

August 24, 2011

Record last verified: 2011-08

Locations

US(2)CA(1)