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Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients

ConditionsChronic Obstructive Pulmonary DiseaseCOPD Exacerbation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinact

About this trial

The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1)<65%;

2) AHRF (pH<7,35 and PaCO2≥45mm Hg (≥6kPa) treated more than 24h with Ventilation (non-invasive or invasive);

3) 48h to 2 weeks with pH>7.35, and PaCO2>45 (>6kPa) after NIV withdrawal, during daytime at rest without oxygen or ventilatory support (or with O2 if patients are not able to avoid O2 with immediate desaturation below 80%).

Disqualifiers

Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment;

Primary diagnosis of restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the "FEV1/Forced vital capacity (FVC)" ratio is <60% and the FEV1 <50% if the predominant defect is considered to be obstructive by the center clinician;

BMI > 35 kg/m2;

Sedative medication causing hypercapnia (> 3 drugs or more than 20mg of morphine/day);

Trial design

Design model

Sequential

Treatments tested in this trial

  • home ventilators

    Device

    The 3 test treatments are home non-targeted NIV, home targeted NIV and rescue home NIV. COPD patients will be equipped with home ventilators and fitted with either nasal, oronasal or facial masks. All the ventilators used will be CE marked.

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Non-targeted home NIVActive comparator 1 intervention
Group C: Targeted home NIVActive comparator 1 intervention
Group D: Rescue home NIVActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

admission-free survival

defined as time from randomisation to hospital admission in relation with severe exacerbation of COPD or death from any cause, whichever event occurred first, estimated using the Kaplan-Meier method. If neither event occurs, then time will be taken from day randomisation to the last known follow up visit. If withdrawal occurs prior to death, time will be taken from the day of randomisation to day of withdrawal.

Time frame
0-36 months

Secondary outcomes

1

Overall survival

estimated using the Kaplan-Meier method

Time frame
0-36 months
2

Frequency of exacerbations requiring hospitalization

The number of patients that experience one or more exacerbations resulting in hospitalisation

Time frame
12 months
3

Frequency of exacerbations resulting in physician directed treatment

The number of patients that experience an exacerbation resulting in physician directed treatment, self-management or no treatment change;

Time frame
12 months
4

Assessment of Exacerbation based on changes in arterial pressure of carbon dioxide

Change in arterial partial pressure of carbon dioxide (PaCO2) in mmHg

Time frame
0, 1, 3, 6, 12, 18, 24, 30 and 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinact

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Collaborator

Fondation du Souffle

Collaborator

Source ClinicalTrials.gov
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