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BronchiectasisNCT00452114

In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis

A study testing In-Exsufflator Cough Assist Device and Active Comparator: Flutter Valve Device in people with Bronchiectasis, run by University of Massachusetts, Worcester at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bronchiectasis
What is being tested?
In-Exsufflator Cough Assist Device and Active Comparator: Flutter Valve Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesUnited States
Study dates
Apr 2004to May 2008
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Inability to speak and read English
  • Inability to demonstrate proper use of the cough-assist or flutter device
  • Unable to provide informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • UMass Memorial Medical Center, Universty Campus

    Worcester, Massachusetts, 01605

  • St. Vincent Medical Center

    Worcester, Massachusetts, 01608

Other trials in United States

About this study

Official title: A Randomized, Controlled Study Evaluating the Effectiveness of the Inexsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis

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.

Read the detailed description

Bronchiectasis is characterized by airway dilatation with the potential to cause devastating illness, including repeated respiratory infections requiring antibiotics, disabling productive, mucopurulent cough, shortness of breath and occasional hemoptysis. The damaged and dilated airways lead to persisting bacterial infection of the bronchi and bronchioles, causing inflammation and retained secretions, which in turn may further damage the airways. Patients typically suffer from frequent, severe and refractory episodes of bacterial bronchitis, often requiring hospitalization and prolonged courses of antibiotics. The pathophysiology of bronchiectasis involves the retention of viscid, tenacious inflammatory secretions and microbes leading to a "vicious cycle" of airway obstruction, destruction and recurrent infection with further compromise of the mucociliary clearance host defense apparatus. It has been widely proposed and recommended that methods of enhancing clearance of airway secretions should be an integral component of the care of patients with bronchiectasis. Despite these recommendations and a sound pathophysiologic plausibility given the central role retention of secretions plays in the disease, the effectiveness of interventions targeted toward enhancing bronchopulmonary hygiene has not been systematically studied. It is also not known whether the ability to generate an adequate cough would predict which patient will benefit from these interventions.

The mechanical in-exsufflator device assists patients in clearing retained secretions by augmenting the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure. An effective cough mechanism is actually an important and beneficial host defense which aids in mucus clearance along with the mucociliary apparatus. We hypothesize that daily, regular use of the in-exsufflator device will lead to a reduction in acute bronchiectasis exacerbations- a clinically meaningful endpoint- with other possible beneficial outcomes including improved pulmonary function, improved health-related quality of life and decreased health care costs.

Despite the lack of rigorous, well-designed studies supporting the role and most effective mode of bronchial hygiene physiotherapy in patients with bronchiectasis, many Pulmonologists recommend the flutter valve device as the generally accepted "standard of care" at this time due to its relative non-invasiveness, ease of use and high level of patient acceptability. The flutter valve is a simple, hand-held, pipe-like device which helps loosen secretions by providing an expiratory low-pressure vibratory pulse to the patient's airway when used. This study will provide a comparison of the clinical efficacy of these mechanical chest physiotherapy devices in the setting of bronchiectasis.

Conditions
Bronchiectasis
Being tested
In-Exsufflator Cough Assist Device, Active Comparator: Flutter Valve Device
Keywords
Bronchiectasis
Medical subject headings
Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-Exsufflator Cough Assist DeviceDevice

  • Active Comparator: Flutter Valve DeviceDevice

    Active Comparator

Study groups in NCT00452114
Study groupRoleWhat they receive
Assignment to In-Exsufflator Cough Assist DeviceActive comparatorIn-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
Receives: Device: In-Exsufflator Cough Assist Device
Assignment to flutter valve deviceActive comparatorflutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
Receives: Device: Active Comparator: Flutter Valve Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

Secondary outcomes (2)
  1. Quality of Life (St. George's Respiratory Questionnaire)

    Quality of life is measured using St. George's Respiratory Questionnaire, a 50 item disease-specific instrument designed to measure impact on overall health, daily life and perceived well-being in patients with obstructive airways disease. The instrument consists of 2 parts, and 3 components. Part 1 measures symptom frequency and severity with a 1,3 or 12 month recall. Part 1 is evaluated using several scales. Part 2 measures impact of breathlessness on activities including social functioning and psychological disturbances. Part 2 is evaluated by dichotomous (true false) evaluation except the final question which is a 4 point likert scale. Scores range from 0 to 100 with higher score indicating more limitation and lower quality of life.

    Measured: 12 months

  2. Quality of Life (Cough-Specific Quality of Life Questionnaire)

    Quality of life is measured using the Cough Specific Quality of Life Questionnaire (CQLQ) to measure the effect of interventions on cough-specific quality of life. The Cough-Specific Quality of Life Questionnaire consist of 28 questions about cough and its effects using Likert-like 4-point scales, with lower scores indicating less effect of cough on health related quality of life.

    CQLQ scale ranges from 28 to 112 with higher scores indicating worse outcome or status.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2007 (estimated)
  2. Study startApr 2004
  3. Primary completionMay 2008
  4. Study completionMay 2008

Why it stopped: interim analysis indicates statistical futility for primary outcomes

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00452114
Sponsor's protocol ID
H-11138
Status last verified
Aug 2018
First submitted
22 Mar 2007
Last updated
18 Sep 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing In-Exsufflator Cough Assist Device and Active Comparator: Flutter Valve Device in people with Bronchiectasis, run by University of Massachusetts, Worcester at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Suppurative Exacerbations Per Patient Per Year (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.

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