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PEEP Mask for Tracheobronchomalacia-Induced Cough

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ClinicalTrials.gov Identifier: NCT04169282
Recruitment Status : Not yet recruiting
First Posted : November 19, 2019
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study aims to determine if an expiratory resistance device that delivers non-invasive positive expiratory pressure (nPEP) will reduce or stop coughing, reduce airway resistance and improve quality of life in patients with tracheobronchomalacia (TBM) who are not candidates for tracheal stenting.

Condition or disease Intervention/treatment Phase
Tracheobronchomalacia Device: nPEP (non-invasive positive expiratory pressure) mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Positive Expiratory Pressure Mask (PEEP-Mask) for Tracheobronchomalacia Associated Cough
Estimated Study Start Date : January 30, 2021
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: nPEP Recipients
Single-patient, adjustable expiratory resistance device that provides positive pressure (5 to 20 cm H2O) during expiration
Device: nPEP (non-invasive positive expiratory pressure) mask
Positive end expiratory pressure (PEEP) mask




Primary Outcome Measures :
  1. Change in cough severity as measured by the Cough-Visual Analog Scale [ Time Frame: Pre-baseline, baseline, two weeks ]
    The primary objective is to determine if use of the nPEP device will change cough severity. Responses to the Cough-Visual Analog Scale range from 0-100 mm, with higher scores corresponding to worse outcomes.

  2. Change in quality of life as measured by the Cough-Specific Quality-of-Life Questionnaire [ Time Frame: Pre-baseline, baseline, two weeks ]
    The objective is to determine if use of the nPEP device will change cough-related quality of life. Responses to the Cough-Specific Quality-of-Life Questionnaire range from 28-112, with higher scores corresponding to worse outcomes.

  3. Change in quality of life as measured by the Leicester Cough Questionnaire [ Time Frame: Pre-baseline, baseline, two weeks ]
    The objective is to determine if use of the nPEP device will change cough-related quality of life. Responses to the Leicester Cough Questionnaire range from 19-133, with lower scores corresponding to worse outcomes.


Secondary Outcome Measures :
  1. Change in proximal airway resistance as assessed by impulse oscillometry [ Time Frame: Baseline, two weeks ]
    The secondary objective is to determine if use of the nPEP device changes airway physiology, specifically proximal airway resistance, as assessed by impulse oscillometry.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Chronic cough for at least 8 weeks
  • Visualization of ≥50% collapse of the trachea or mainstem bronchus on CT scan or bronchoscopy
  • No upper or lower respiratory infection within 4 weeks
  • Negative evaluation or treatment response for cough:

    • Asthma (negative spirometry or treatment with oral corticosteroids or ≥moderate dose of inhaled corticosteroids)
    • Gastroesophageal reflux disease (GERD) (negative potential hydrogen (pH) probe or treatment with proton pump inhibitor)
    • Upper airway disease (nasal or oral corticosteroids, antihistamines)
    • Chronic Obstructive Pulmonary Disease (COPD) (negative spirometry or treatment with triple-inhaled therapy [≥moderate dose of inhaled corticosteroids, long-acting muscarinic antagonist, and long-acting beta agonist])
  • Having capacity to provide legal written informed consent

Exclusion Criteria:

  • History of tracheobronchoplasty or chronic tracheal stenting
  • Current tracheostomy
  • History of external chest trauma
  • History of mediastinal goiter
  • Current smoking within 6 months
  • Current use of angiotensin-converting enzyme (ACE) inhibitor within 6 weeks
  • Primary parenchymal lung disease
  • History of:

    • Sarcoidosis
    • Interstitial lung disease
    • Chronic mycobacterial infection
    • Lung cancer
    • Lung transplantation
    • Unstable congestive heart failure
    • History of spontaneous pneumothorax
  • Other medical conditions that interfere with participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169282


Contacts
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Contact: Antoinette Santoro, MS, BSRT (919) 479-0861 maria.santoro@duke.edu
Contact: Catherine Foss, BS, RRT (919) 479-0861 catherine.foss@duke.edu

Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Loretta G Que, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04169282    
Other Study ID Numbers: Pro00102498
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
tracheobronchomalacia
TBM
cough
Additional relevant MeSH terms:
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Tracheobronchomalacia
Respiratory Tract Diseases
Cartilage Diseases
Musculoskeletal Diseases
Bronchial Diseases
Tracheal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases