Trial Outcomes & Findings for In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis (NCT NCT00452114)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

12 months

Results posted on

2018-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	In-Exsufflator Cough Assist Device 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	Flutter Valve Device flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
Overall Study STARTED	15	13
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	In-Exsufflator Cough Assist Device 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	Flutter Valve Device flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
Overall Study Physician Decision	3	3

Baseline Characteristics

In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	In-Exsufflator Cough Assist Device n=15 Participants 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	Flutter Valve Device n=13 Participants flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	13 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Participants in the Intervention Group (Cough In-exsufflator) n=12 Participants	Particpants in the Control Group (Flutter Device) n=10 Participants
Number of Suppurative Exacerbations Per Patient Per Year	2.5 Number of events per patient Standard Deviation 1.7	2.3 Number of events per patient Standard Deviation 2.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants in the Intervention Group (Cough In-exsufflator) n=12 Participants	Particpants in the Control Group (Flutter Device) n=10 Participants
Number of Hospitalizations and Urgent/Unscheduled Outpatient Visits	.78 Number of Hospitalizations/Visits Standard Deviation .8	.87 Number of Hospitalizations/Visits Standard Deviation 1.2

SECONDARY outcome

Timeframe: 12 months

Population: Outcomes not analyzed

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.

Outcome measures

Outcome measures
Measure	Participants in the Intervention Group (Cough In-exsufflator) n=12 Participants	Particpants in the Control Group (Flutter Device) n=10 Participants
Quality of Life (St. George's Respiratory Questionnaire)	30 scores on a scale Standard Deviation 14	24 scores on a scale Standard Deviation 9

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Participants in the Intervention Group (Cough In-exsufflator) n=12 Participants	Particpants in the Control Group (Flutter Device) n=10 Participants
Quality of Life (Cough-Specific Quality of Life Questionnaire)	48 Scores on a scale Standard Deviation 15	43 Scores on a scale Standard Deviation 10

Adverse Events

In-Exsufflator Cough Assist Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Flutter Valve Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen Krinzman, Principal Investigator

University of Massachusetts Medical School

Phone: 508-856-1975

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place