Chronic obstructive pulmonary disease (COPD) is a serious lung condition that affects over 600,000 people in Belgium. Many patients experience flare-ups that require hospital admission. Unfortunately, even after treatment, up to half of these patients are readmitted within 90 days of discharge, and some do not survive.
The IN-SPIRED trial is a Belgian multicentre clinical study that investigates whether home-based breathing exercises—called inspiratory muscle training (IMT)—can reduce hospital readmissions or death following a flare-up. IMT strengthens the breathing muscles using a simple device patients use at home, supported through telemonitoring via a smartphone app.
The study includes 358 patients hospitalized for a COPD flare-up. Participants are randomly assigned to receive either IMT plus usual care, or usual care alone. The primary goal is to see whether the addition of IMT leads to fewer hospital readmissions or deaths within 180 days after leaving the hospital.
The trial is conducted in 12 hospitals across Belgium. If effective, this low-cost intervention could become part of routine care to improve outcomes for people living with COPD and reduce pressure on the healthcare system.
| Title | IN-SPIRED: a randomised, multicentre, parallel group clinical trial to investigate the effect of home-based inspiratory muscle training compared to usual care on readmission rate in patients after a severe acute exacerbation of chronic obstructive pulmonary disease |
| Participants (P) | Patients aged 35 and above with chronic obstructive pulmonary disease (COPD) hospitalised due to an acute exacerbation, without other significant pulmonary disease or acute cardiac instability. |
| Intervention (I) | Home inspiratory muscle training (IMT), with 2 sessions daily during the intensive phase (days 0 to 90) and once daily during the maintenance phase (days 91 to 180), in addition to usual care. IMT will be performed using a device (either Airofit PRO 2.0 or POWERBreathe Medic Plus) and supported with a smartphone app. IMT will also be supervised in 9 telemonitoring sessions. |
| Control (C) | Usual care includes: • optimal pharmacological therapy per international guidelines including long-acting bronchodilators, inhaled corticosteroids and long-term macrolides at the discretion of the treating physician • advice on smoking cessation • vaccination • physical activity participation for example advised to attend community physiotherapy or a hospital ambulatory respiratory rehabilitation program based on accessibility and patient preference |
| Outcome (O) | A composite endpoint defined as all-cause hospital readmission or death within 180 days after hospital discharge |
| Trial Design | Randomized, multicentre, parallel-group clinical superiority trial |
| Sample Size | 358 participants |
| Trial duration | 42 months from FPI to CSR |
| Budget | 1,650,000 € |
| Sponsor | UZ Leuven |
| Chief Investigator | Prof. Dr. PT. Daniel Langer |
| External partners | not applicable |
| Number of participating sites | 12 sites in Belgium (3 Wallonia, 2 Brussels and 7 Flanders) |
