Novel Therapies for Muco-Obstructive Lung Diseases: Testing the Transnasal Pulmonary Delivery Device in COPD/CB Subjects

NCT02341183 | Withdrawn FDA Device

• 1 other identifier: Pro00057004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess tolerability and effect of HS (hypertonic saline) delivered with the tPAD (transnasal Pulmonary Aerosol Delivery) device on mucociliary clearance (MCC) in chronic obstructive pulmonary disease/chronic bronchitis (COPD/CB) subjects. The investigators hypothesize that HS delivery via tPAD will be safe and and while, and will improve MCC.

Conditions

COPD; Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• Mucociliary Clearance Rate (MCC60)

  The primary study outcome, MCC60, will serve as the primary descriptor of the mucociliary clearance rate. This assay will be begun as quickly as possible after competing the tPAD treatment (\<60 minutes in all cases). MCC60 is derived by calculating the average rate of particle clearance observed during the first 60 minutes of the MCC scan procedure (MCC60; units = % cleared/time), using clearance values determined every 10 minutes for 60 minutes following inhalation of radiolabeled particles. Results obtained immediately after tPAD treatment will be compared to baseline values. Similarly, average clearance through other time domains (30 min, 90 min, 24 hrs), and from specific regions of interest (central lung; peripheral lung) will be reported as secondary MCC outcomes.

  The MCC outcome measure will be performed as quickly as possible (within 60 minutes) after overnight tPAD treatment

Secondary Outcomes (2)

• Symptom survey

  The outcome measure will be assessed after visits 1 and 3, immediately following each overnight visit (tPAD vs. no treatment)

• Spirometry

  Spirometry will be performed before each treatment visit (tPAD vs. no treatment) on Visit 1 and 3, and again after completing the assigned treatment, approximately 12 hours later

Study Arms (2)

A: Treatment order: tPAD treatment, then no treatment

ACTIVE COMPARATOR

Subjects will receive one overnight treatment with 7% hypertonic saline administered via the tPAD device. They will then have one overnight stay without treatment.

Device: tPAD; Device: 7% hypertonic saline (510K approved as a device)

B: Treatment order: no treatment, then tPAD treatment

ACTIVE COMPARATOR

Subjects will have overnight stay w/o treatment, and one overnight treatment with 7% hypertonic saline administered via the tPAD device.

Device: tPAD; Device: 7% hypertonic saline (510K approved as a device)

Interventions

tPAD DEVICE

7% NaCl administered continuously for 8 hours, overnight, via the tPAD device

A: Treatment order: tPAD treatment, then no treatment; B: Treatment order: no treatment, then tPAD treatment

7% hypertonic saline (510K approved as a device) DEVICE

Subjects will receive overnight treatments of 7% HS via the tPAD device in both comparators, but in a randomly assigned order as described.

A: Treatment order: tPAD treatment, then no treatment; B: Treatment order: no treatment, then tPAD treatment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who meet the following criteria will be eligible for study participation:
• Subjects aged 40 to 80 years (inclusive), and with a body mass index (BMI) \< 35 kg/m2
• Female subjects must be non-pregnant and must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or, must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation
• Subjects who are in their baseline state of health, as determined by a medical history and examination
• Subjects who have normal lung function with a FEV1 of 30% - 80% predicted and a FEV1/FVC \<70%
• Subjects who are capable of providing written informed consent in English to participate in the study
• Produces sputum two days per week or more, on average.
• History of smoking cigarettes ≥ 10 pack years.

You may not qualify if:

• Subjects will be excluded from the study according to the following criteria:
• Subjects who use oxygen continuously or require it at night.
• Subjects with an FEV1 \< 30% or \> 80% or an FEV1/FVC of ≥70% at screening.
• Subjects who chronically require \> 10mg per day of prednisone (or equivalent corticosteroid dose).
• Subjects with a concomitant presence of congestive heart failure, active coronary syndromes, or other disease that in the opinion of the investigator would increase the risk resulting from participation.
• Subjects with a recent change in respiratory medications, including new antibiotic or systemic corticosteroid interventions within the last 4 weeks.
• Subjects with a history of intolerance or hypersensitivity to hypertonic saline or short acting inhaled beta agonists.
• Subjects with significant bronchoreactivity by examination or PFT testing that, in the opinion of the investigator, would increase the risk of HS use.
• Subjects who have had radiation exposure within the 12 months prior to study participation that would cause them to exceed Federal Regulations by participating in this study.
• Subjects with symptomatically active, chronic or acute rhinosinusitis, or other nasal abnormality that could interfere with aerosol delivery or impact subject safety.
• Subjects with a positive pregnancy test or who are nursing.
• Subjects who have been diagnosed with obstructive sleep apnea.
• Subjects who, in the opinion of the Principal Investigator, should not participate in the study.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Scott H. Donaldson, MD

  Associate Professor, Department of Medicine, Division of Pulmonary/Critical Care Medicine, UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: January 19, 2015
• Study Start: May 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 23, 2017

Record last verified: 2016-05

Locations

US (1)