Assessing Optimal Inhaler Strategies During Acute Exacerbations of COPD (AECOPDs) Using Oscillometry
NCT Number: NCT06495047
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: COPD|COPD Exacerbation Acute
Interventions: DRUG: Long-acting bronchodilator therapy (LABD)|DRUG: Short-acting bronchodilator therapy (SABD)
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: MEI/MES I&P Program (McGill University, Thorasys Inc.)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 43
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-19
Completion Date: 2025-12-31
Locations: McGill University Health Centre, Montréal, Quebec, H4A 3J1, Canada

Summary:
Chronic Obstructive Pulmonary Disease (COPD) is a persistent lung disease that makes it very difficult to breathe. The airways and the normally 'spongy' lungs themselves are affected. The main treatment is puffers, some which are long-acting (to control persistent symptoms) and some which are short-acting ('rescue' puffers when suddenly feeling short-of-breath). Beyond persisting breathlessness at rest, people with COPD can also experience dangerous "lung-attacks" which can require urgent care visits or even hospitalization for treatment. Amazingly, although COPD is the third leading cause of death worldwide, and COPD lung-attacks are a leading cause of hospitalization in Canada, investigators are still unsure which combination of puffers is most effective at treating lung-attacks.

The main objective is to determine which puffer treatment combination (just short-acting, or both short-acting and long-acting) best opens up the lungs to airflow during COPD lung-attacks.

A test called oscillometry, which requires only quiet breathing and is so safe that it is regularly used in children, toddlers and even infants, will be used to measure lung function changes. All eligible people with COPD receiving urgent lung-attack treatment who agree to participate will perform three rounds of oscillometry: before any puffers, after only short-acting puffers, and finally after long-acting puffers are also added on. Any potential evidence of side effects will be collected from the chart. Oscillometry tests will be compared to see which puffer strategy best improves flow in the airways.

Part of the reason why this has not been well-studied so far is that the standard breathing test, spirometry, requires multiple rounds of forceful breathing which is very difficult, even distressing, for many people with COPD (at rest, let alone during a lung-attack). No studies have ever properly studied which puffer strategy is most effective for lung-attacks. The investigators have experience and expertise with oscillometry, the most appropriate test in this setting, to answer this pressing question.

This research addresses an important treatment knowledge gap for this very common lung disease. These results could influence how patients with COPD around the world are treated during lung-attacks so that they can breathe better, sooner.

Primary Outcome Measures: Reactance-volume loop area (AXV), Parameter collected by intra-breath (within-breath) oscillometry. The area within the reactance-volume curve, during tidal breathing., 1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).|Mean inspiratory minus expiratory respiratory system reactance (mean ∆Xrs), Parameter collected by intra-breath (within-breath) oscillometry. The reactance during inspiration, minus the reactance during expiration, during tidal breathing., 1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).
Secondary Outcome Measures: Visual analog scale (VAS) Dyspnea Score, Validated visual representation of shortness of breath., 1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).|Resistance at 5 Hz (R5), Parameter collected by spectral oscillometry. The resistance as measured by oscillometry at 5 Hz., 1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).|Reactance at 5 Hz (X5), Parameter collected by spectral oscillometry. The reactance as measured by oscillometry at 5 Hz., 1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).|Frequency Dependence of Resistance (R5-20), Parameter collected by spectral oscillometry. The resistance as measured by oscillometry at a range from 5 Hz to 20 Hz., 1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).|Reactance Area (Ax), Parameter collected by spectral oscillometry. The area under the reactance curve., 1) At baseline (before bronchodilators); 2) 15-20 minutes after SABD but before LABD; and 3) after SABD and LABD (25-35 minutes following SABD).