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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.
Last refreshed on: 19 October 2017
Main ID:  NCT01094704
Date of registration: 19/03/2010
Prospective Registration: No
Primary sponsor: University of North Carolina, Chapel Hill
Public title: Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis
Scientific title: Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis
Date of first enrolment: November 2009
Target sample size: 16
Recruitment status: Completed
Study type:  Interventional
Study design:   
Phase:  Phase 1
Countries of recruitment
United States
Name:     William Bennett, PhD
Affiliation:  University of North Carolina, Chapel Hill
Key inclusion & exclusion criteria

Inclusion Criteria:

- Gender: Male or female (non-pregnant, non-lactating)

- Cystic fibrosis documented by a compatible clinical and radiographic presentation, and
sweat chloride > 60 mEq/l or 2 disease causing CFTR mutations.

- Severity of Disease:

1. Must have FEV1 of greater than or equal to 50% of predicted at the screening

2. Must have an oxygen saturation of >92% on room air as determined by pulse
oximetry at the screening visit.

- Patient or legally authorized representative agrees to the patient/individual's
participation in the study by signing and dating the informed consent form after the
nature of the study has been fully explained and all questions have been
satisfactorily answered.

Exclusion Criteria:

- Unstable 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; or a
significant new finding on chest radiograph (pneumothorax, lobar/segmental collapse)
not considered a part of the usual, chronic progression of CF lung disease.

- Patients unable or unwilling to be withdrawn from hypertonic saline therapy, dornase
alfa, or N-acetylcysteine 3 days prior to and for the duration of each Baseline and
Treatment Period will be excluded.

- Patients unable to withhold use of long-acting bronchodilators (i.e., Salmeterol,
Advair, Formoterol), anti-cholinergics, and vest therapy 12 hours prior to and for the
duration of each treatment period.

- Patients unable to withhold short-acting bronchodilator 6 hours prior to and for the
duration of each treatment period except as prescribed by the study protocol.

- Patients that have received an investigational drug or therapy during the preceding 30

- Patients that have had radiation exposure within the past year that would cause them
to exceed Federal Regulations by participating in this study.

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Drug: sodium chloride (7%)
Primary Outcome(s)
Change in Average Mucociliary Clearance (0-90 Minutes) at 1 and 4 Hrs Post Dose (MCC4hr - MCCbaseline; MCC1hr - MCCbaseline) [Time Frame: 1-4 hours post-dose]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Johns Hopkins University
Novartis Pharmaceuticals
Ethics review
Results available: Yes
Date Posted: 21/08/2012
Date Completed:
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