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Vector Efficacy Cross-Over Pilot Study
trial testing Modified BiPAP A40 with Vector Algorithm (Vector) in Chronic Obstructive Pulmonary Disease in 21 participants. Terminated before completion.
| Lead sponsor | Philips Clinical & Medical Affairs Global |
|---|---|
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 21 January 2020 |
| Primary completion | 17 November 2023 |
| Estimated completion | 17 November 2023 |
| Sites | 1 location across United States |
Philips Clinical & Medical Affairs Global — full company profile →
Adults 40 to 80, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Room air CO2 levels at the end of 4-6 weeks of therapy as determined by Arterial Blood Gas (PaCO2)
| Group | Value | 95% CI |
|---|---|---|
| Vector Device (NIV Current Users) | 59.2 | ± 16.6 |
| Standard of Care NIV (NIV Current Users) | 49.8 | ± 8.8 |
How many hours per night over 30 days that the participant uses the device.
| Group | Value | 95% CI |
|---|---|---|
| Vector Device (NIV Current Users) | 7.58 | ± 4.52 |
| Standard of Care NIV (NIV Current Users) | 7.40 | ± 3.38 |
Comfort data from device satisfaction/preference questionnaire after 30 days of device use. The specific question analyzed was " Which ventilator pressure settings or therapy did you prefer?" Outcome was number of participants who selected each therapy as preferred.
| Group | Value | 95% CI |
|---|---|---|
| Vector Device (NIV Current Users) | 3 | |
| Standard of Care NIV (NIV Current Users) | 3 |
Incidence of Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) for the Vector vs. the control group.
| Group | Value | 95% CI |
|---|---|---|
| Vector Device (NIV Current Users) | 3 | |
| Standard of Care NIV (NIV Current Users) | 0 |
Time frame: Approximately 15 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | NIV Current Users: Vector | NIV Current Users: Standar… |
|---|---|---|---|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | — | — |
| Shortness of Breath and left sided chest discomfort | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypervolemia | Blood and lymphatic system disorders | — | — |
| Reaction | System | NIV Current Users: Vector | NIV Current Users: Standar… |
|---|---|---|---|
| Abnormal Blood gas level | Respiratory, thoracic and mediastinal disorders | — | — |
| Ear pain | Ear and labyrinth disorders | — | — |
| Motor Vehicle Accident | Injury, poisoning and procedural complications | — | — |
Most-reported serious reactions: COPD exacerbation, Shortness of Breath and left sided chest discomfort, Hypervolemia.
Data from ClinicalTrials.gov NCT04263532 adverse events section.
The study evaluates the safety and efficacy of the modified Bi-level positive airway pressure (BiPAP) A40 with Vector Algorithm to treat Chronic Obstructive Pulmonary Disease (COPD) patients with excessive carbon dioxide in their bloodstream (hypercapnia) and expiratory flow limitation (EFL), a constriction of the lower airways. The study will include current users of non-invasive ventilation (NIV) as well as those who are not currently using an NIV device.
No peer-reviewed publications indexed yet for this trial.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing