Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| MEI/MES I&P Program (McGill University, Thorasys Inc.) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Three sets of carefully timed oscillometry and dyspnea score measurements will be performed: 1) at "baseline", before the participant receives their scheduled dose of LABD and roughly 4 hours following a scheduled dose of SABD; 2) between 15-20 min after having received their next scheduled dose of SABD and just preceding their next scheduled dose of LABD (SABD only); and 3) after having received the scheduled dose of LABD and between 25-35min of the most recent SABD administration (LABD + SABD), such that there is overlap in the time window of SABD and LABD onset at the time of the third set of testing.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD cohort | Males and females aged 40 or greater with any severity of airflow obstruction (GOLD 1-4) who are currently experiencing and receiving treatment for a physician-diagnosed acute exacerbation (AECOPD) with both long-acting and short-acting bronchodilators prescribed by the treating team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long-acting bronchodilator therapy (LABD) | Drug | Long-acting inhaler therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients with COPD diagnosed with and receiving treatment for an acute exacerbation (AECOPD) who are being treated with both short-acting and long-acting bronchodilator therapies. Convenience sampling approach.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
Due to data privacy regulations, individual participant data collected during this study is not publicly accessible. However, access to anonymized data may be granted upon evaluation by the trial management group. Additional documents will also be available upon inquiry. All requests should be directed to the corresponding author (BAR).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Short-acting bronchodilator therapy (SABD) |
| Drug |
Short-acting inhaler therapy |
|
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). |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided