N/A
Completed N=54
Study to Compare (COPD) Assessment Test in COPD Stage III and IV in a Prophylactic Treatment
Source: ClinicalTrials.gov NCT01679314 ↗Enrolled (actual)
54
Serious AEs
7.4%
Results posted
May 2016
Primary outcomePrimary: Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups — -1.3; -0.9 units on a scale
Summary
The study will assess the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) stage III and IV who will self administer the AlphaCore stimulation three times a day over a course of 2 months. Patients will either receive an active AlphaCore device or a Sham device during these two months while not knowing which device they have been provided. At the end of the two months, all patients will be asked to continue in the study for another 2 months to self administer with the active AlphaCore device. Subjects will complete diaries at home on their breathing and quality of life and will return to the clinic monthly for assessment by the investigator.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups |
-1.3; -0.9 | — |
| SECONDARY Change in Borg Dyspnoea Scores |
0.7; 0.4 | — |
| SECONDARY Change 6 Minutes Walking Test |
8.1; 12.6 | — |
| SECONDARY Change in Forced Expiratory Volume (FEV1) |
30.7; 29.7; 31.0; 31.0 | — |
| SECONDARY Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L) |
7; 6; 8; 7; 17; 21 | — |
| SECONDARY Number of Subjects With Adverse Events (AE) |
10; 6 | — |
| SECONDARY Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS) |
53.3; 51.6; 52.8; 55.7 | — |
Eligibility Criteria
Inclusion Criteria
- Age 40-75 years
- Diagnosed Chronic obstructive pulmonary disease(COPD) stage III and IV according to Global Initiative for chronic obstructive lung disease (GOLD) guideline
- Forced expiratory volume in one second (FEV 1) < 50%
- Forced expiratory volume in one second (FEV1/Forced expiratory vital capacity (FVC) < 70%
- Signed informed consent form
Exclusion Criteria
- Participation in other clinical trials (drug or medical device) 30 days prior to start of this study
- Subject is unable to comply with the procedures if the protocol for the study or any other reason judged by the Investigator that could interfere with the study assessment or follow-up
- Has an abscess or other infection or lesion (including lymphadenopathy) at the AlphaCore® treatment site.
- Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
- Has a history of carotid endarterectomy or vascular neck surgery on the right side.
- Right side or bilateral vagotomy
- Has a recent or repeated history of syncope.
- Has a recent or repeated history of seizures.
- Pregnant or breast feeding women
Data sourced from ClinicalTrials.gov (NCT01679314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.