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.
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
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Active Comparator: Flutter Valve Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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.
- First posted26 Mar 2007 (estimated)
- Study startApr 2004
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: interim analysis indicates statistical futility for primary outcomes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Krinzman, University of Massachusetts, Worcester
- Investigators
- Stephen J Krinzman, MD, Principal investigator, University of Massachusetts, Worcester
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study Evaluating the Effectiveness of the Inexsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis
- ClinicalTrials.gov ID
- NCT00452114
- Acronym / sponsor ID
- H-11138
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis indicates statistical futility for primary outcomes
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 26 Mar 2007 (estimated)
- Results
- Posted 6 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assignment to In-Exsufflator Cough Assist Device | Active comparator | Device: In-Exsufflator Cough Assist DeviceIn-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 |
| Assignment to flutter valve device | Active comparator | Device: Active Comparator: Flutter Valve Deviceflutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chest CT scan confirmation of bronchiectasis
- At least two exacerbations in the preceding 12 months requiring antibiotics
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Exsufflator Cough Assist Device | Device | Assignment to In-Exsufflator Cough Assist Device |
| Active Comparator: Flutter Valve DeviceActive Comparator | Device | Assignment to flutter valve device |
Primary outcome
Number of Suppurative Exacerbations Per Patient Per Year
Time frame: 12 months
The impact of the intervention is measured by the total number of suppurative exacerbations per patient within a 12 month period.
Number of Hospitalizations and Urgent/Unscheduled Outpatient Visits
Time frame: 12 months
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.
2 secondary outcomes
Quality of Life (St. George's Respiratory Questionnaire)
Time frame: 12 months
Quality of Life (Cough-Specific Quality of Life Questionnaire)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J Krinzman, MD principal investigator
University of Massachusetts, Worcester
2 sites in 1 country: see every site and its status.
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.