Clinical trial NCT00452114: In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis
Official title: A Randomized, Controlled Study Evaluating the Effectiveness of the Inexsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiectasis
Keywords: Bronchiectasis
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2007-03-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Suppurative Exacerbations Per Patient Per Year
timeFrame: 12 months
measure: Number of Hospitalizations and Urgent/Unscheduled Outpatient Visits
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life (St. George's Respiratory Questionnaire)
timeFrame: 12 months
measure: Quality of Life (Cough-Specific Quality of Life Questionnaire)
timeFrame: 12 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center, Universty Campus
state: Massachusetts
city: Worcester
country: United States
facility: St. Vincent Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Stephen J Krinzman, MD
role: PRINCIPAL_INVESTIGATOR
References: