NCT02141191

Brief Summary

The primary objective of this study is to determine whether a single overnight, eight-hour administration of a 7% NaCl solution delivered by the Parion Sciences transnasal Pulmonary Aerosol Delivery (tPAD) device has a significant effect on mucociliary clearance in subjects with cystic fibrosis, as compared to no treatment. This study will be conducted at the University of Pittsburgh Medical Center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

May 12, 2014

Last Update Submit

July 24, 2017

Conditions

Cystic Fibrosis

Keywords

cystic fibrosishypertonic salinenebulizernasal cannula

Outcome Measures

Primary Outcomes (1)

  • mucociliary clearance

    Mucociliary clearance as assessed through the imaging of radiolabeled particles

    6 hours

Secondary Outcomes (6)

  • safety and tolerability measurements

    12 hours

  • pulmonary function measurements

    12 hours

  • safety and tolerability measurements

    12 hours

  • safety and tolerability measurements

    12 hours

  • safety and tolerability measurements

    12 hours

  • +1 more secondary outcomes

Study Arms (2)

HS/sham

EXPERIMENTAL

Subjects will utilize inhaled hypertonic saline (7%) delivered using the tPAD device during one session and perform a sham treatment with the tPAD during the other. The order will be randomized.

Drug: inhaled hypertonic saline (7%)

sham/HS

EXPERIMENTAL

Subjects will utilize inhaled hypertonic saline (7%) delivered using the tPAD device during one session and perform a sham treatment with the tPAD during the other. The order will be randomized.

Drug: inhaled hypertonic saline (7%)

Interventions

inhaled hypertonic saline (7%)DRUG

Inhaled hypertonic saline delivered by nasal cannula using the Parion transnasal Pulmonary Aerosol Delivery (tPAD) device

Also known as: PulmoSal 7% (pH+)
HS/shamsham/HS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has a diagnosis of CF via standard criteria
  • Is aged 18 years or older
  • Is capable of providing written informed consent in English to participate in the study.
  • Has a forced expiratory volume in 1 second (FEV1) \>= 40% and \< 110% predicted normal for age, gender, and height at Screening.
  • Has a body mass index (BMI) \< 30 kg/m2
  • Can tolerate cessation of treatment with HS for 72 hours and rhDNase for 24 hours prior to each treatment visit until discharge from Visits 2 and 3.
  • Can tolerate cessation of treatment with long-acting beta-agonists (LABAs) for 12 hours and short-acting beta-agonists (SABAs) for 6 hours prior to radioaerosol administration for each MCC measurement and at least until discharge from Visits 2 and 3
  • Is on a stable medication regimen for at least 28 days before start of dosing and can continue such regimen for duration of study
  • Tolerates the 30 minute administration of 7% HS by the tPAD device at screening without subjective intolerance, oxyhemoglobin desaturation, or significant change in spirometry (\>10% reduction from pre-dose value in FEV1, measured 30 minutes after completion of the aerosol administration)

You may not qualify if:

  • Has evidence of an acute upper or lower respiratory infection or clinically significant illness at screening or within 28 days prior to the start of dosing
  • Required an acute intervention with antibiotics (oral, inhaled, or IV) or systemic corticosteroids within the last 28 days for a respiratory illness
  • Has a history of intolerance to a beta-agonist or hypertonic saline
  • Has evidence of significant nasal obstruction that impairs the ability to breathe through the nose
  • Has a clinical diagnosis of sleep apnea
  • Has current symptoms of allergic rhinitis
  • Is unable to maintain a stable dosage regimen of any concomitant medication throughout the duration of the trial.
  • Has participated in a clinical drug or investigational device trial within the past 28 days
  • Has a history of positive test for Burkholderia cepacia
  • Has a present history of any clinically significant and uncontrolled neurologic, gastrointestinal, renal, hepatic, cardiovascular (including hyper/hypotension and tachy/bradycardia), psychological, pulmonary, metabolic, endocrine, or hematological disorder or disease, or any other major disorder or disease, in the opinion of the investigator
  • Has a history of smoking within the last 12 months
  • Is known to be pregnant, has a positive urine pregnancy test or is nursing (female subjects only)
  • Should not participate in the study, in the opinion of the Principal or Clinical investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Wark P, McDonald VM, Smith S. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD001506. doi: 10.1002/14651858.CD001506.pub5.

    PMID: 37319354DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Sodium ChlorideHydrogen-Ion Concentration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsChemical Phenomena

Study Officials

  • Joseph M Pilewski, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Bioengineering

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 19, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

US(1)