In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis

NCT00452114 | Terminated Results FDA Device

• 1 other identifier: H-11138
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a randomized, controlled trial examining the effectiveness of the mechanical cough-assist device (in-exsufflator) in promoting the clearance of retained airway secretions in patients with symptomatic bronchiectasis. We hypothesize that this enhanced clearance of airway secretions will lead to a decline in the number of acute exacerbations of bronchiectasis experienced by these patients during the study period, improve health-related quality of life, decrease overall health-care costs and improve pulmonary function.

Conditions

Bronchiectasis

Keywords

Bronchiectasis

Outcome Measures

Primary Outcomes (2)

• Number of Suppurative Exacerbations Per Patient Per Year

  The impact of the intervention is measured by the total number of suppurative exacerbations per patient within a 12 month period.

  12 months

• Number of Hospitalizations and Urgent/Unscheduled Outpatient Visits

  The impact of the intervention is measured by the number of hospitalizations and urgent/unscheduled outpatient visits the participants experienced within a 12 month period.

  12 months

Secondary Outcomes (2)

• Quality of Life (St. George's Respiratory Questionnaire)

  12 months

• Quality of Life (Cough-Specific Quality of Life Questionnaire)

  12 months

Study Arms (2)

Assignment to In-Exsufflator Cough Assist Device

ACTIVE COMPARATOR

In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily

Device: In-Exsufflator Cough Assist Device

Assignment to flutter valve device

ACTIVE COMPARATOR

flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily

Device: Active Comparator: Flutter Valve Device

Interventions

In-Exsufflator Cough Assist Device DEVICE

Assignment to In-Exsufflator Cough Assist Device

Active Comparator: Flutter Valve Device DEVICE

Active Comparator

Assignment to flutter valve device

Eligibility Criteria

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

You may qualify if:

• Chest CT scan confirmation of bronchiectasis
• At least two exacerbations in the preceding 12 months requiring antibiotics

You may not qualify if:

• Cystic fibrosis
• Bullous emphysema
• History of spontaneous pneumothorax
• History of massive hemoptysis: greater than 200 cc in a 24 hour period
• Lung resection surgery in the past 6 months
• Use of the mechanical cough in-exsufflator in the prior 3 months
• Inability to speak and read English
• Inability to demonstrate proper use of the cough-assist or flutter device
• Unable to provide informed consent

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (2)

UMass Memorial Medical Center, Universty Campus

Worcester, Massachusetts, 01605, United States

Location

St. Vincent Medical Center

Worcester, Massachusetts, 01608, United States

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Limitations and Caveats

Study terminated due to low accrual.

Results Point of Contact

• Title: Stephen Krinzman, Principal Investigator
• Organization: University of Massachusetts Medical School

stephen.krinzman@umassmed.edu

508-856-1975

Study Officials

• Stephen J Krinzman, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2007
• First Posted: March 26, 2007
• Study Start: April 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 18, 2018
• Results First Posted: March 6, 2013

Record last verified: 2018-08

Locations

US (2)