|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT01031706 |
|
Date of registration:
|
11/12/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis
|
|
Scientific title:
|
Sustained Impact of Hypertonic Saline on Mucociliary Clearance in Young Children With Cystic Fibrosis |
|
Date of first enrolment:
|
September 2009 |
|
Target sample size:
|
23 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01031706 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Scott H Donaldson, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of North Carolina, Chapel Hill |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Gender: Females or Males. If the subject is female and of childbearing potential
(first menses has occurred), she must have a documented negative pregnancy test at
screening and prior to each mucociliary clearance study. Those of childbearing
potential must be abstinent or using an acceptable method of birth control (i.e. an
Intrauterine Contraceptive Device with a failure rate of <1%, hormonal contraceptives
or a barrier method).
- Age: 5-12 years, inclusive
- Diagnosis: Cystic fibrosis documented by a compatible clinical presentation and sweat
chloride > 60 mEq/l or 2 disease causing CFTR mutations.
- Severity of the Disease: Suitable patients will have mild lung disease, as defined by:
- Pulmonary Function: Each patient must have an FEV1 of greater than or equal to
60% of predicted at the screening visit.
- Hemoglobin saturation: Patients must have an oxygen saturation of >92% on room
air as determined by pulse oximetry at the screening visit.
- Informed consent - The patient and a parent or legally authorized guardian must agree
to the subject's participation in the study by signing and dating the informed
consent/assent forms after the nature of the study has been fully explained and all
questions have been satisfactorily answered.
Exclusion Criteria:
- Unstable or asthmatic lung disease: As defined by a change in medical regimen during
the preceding 2 weeks; an FEV1 15% below recent (within 6 months) clinical
measurements. Patients with a history of co-existent asthma, as manifested by wheezing
and significant bronchoreactivity (>15% increase in FEV1 with bronchodilator), will
also be excluded.
- Other medication usage: Patients unable or unwilling to be withdrawn from hypertonic
saline therapy for two weeks prior to Visit 1 (baseline MCC visit). Patients using
Pulmozyme will be permitted to participate in this trial. Patients on chronic, cycling
antibiotics will be required to have completed at least 2 full cycles of the
prescribed antibiotic prior to enrollment and should not cycle on or off this therapy
during the treatment period of the study.
- Spirometry Performance: Those subjects who are unable to perform acceptable,
reproducible spirometry will be excluded from this study.
- Drug allergy: A history of allergy or intolerance to any of the study medications,
including albuterol or hypertonic saline.
- Have received an investigational drug or therapy during the preceding 30 days.
- Have had radiation exposure within the past year that would cause them to exceed
Federal Regulations by participating in this study.
Age minimum:
5 Years
Age maximum:
12 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cystic Fibrosis
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: Hypertonic Saline
|
|
Primary Outcome(s)
|
|
Change in Mucociliary Clearance Rate
[Time Frame: Baseline versus after completion of 4 week treatment period]
|
|
Secondary Outcome(s)
|
|
FEV1 (Spirometry) Change
[Time Frame: Baseline and after 4 weeks of treatment]
|
|
Secondary ID(s)
|
|
1P50HL084934
|
|
09-1258
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|