Assessing Optimal Inhaler Strategies During Acute Exacerbations of COPD (AECOPDs) Using Oscillometry

Assessment of Optimal Inhaler Therapy Strategies in the Management of Acute Exacerbations of COPD (AECOPDs) Using Oscillometry: A Cross-Sectional Study

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.

Study Overview

• Status: Completed
• Conditions: COPD; COPD Exacerbation Acute
• Intervention / Treatment: Drug: Long-acting bronchodilator therapy (LABD); Drug: Short-acting bronchodilator therapy (SABD)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Males and females, age ≥ 40, who are former/current smokers with a ≥10 pack-year smoking history.
2. COPD previously confirmed by spirometry (FEV1/FVC < 0.7) of any severity (GOLD 1-4).
3. Currently experiencing and receiving treatment for a physician-diagnosed AECOPD with both long-acting and short-acting bronchodilators prescribed by their treating team.
4. Ability to participate without supplemental oxygen during the oscillometry tests.
5. Ability to provide informed consent.

Exclusion Criteria:

1. No COPD diagnosis.
2. AECOPD is not the principal cause of urgent care visit, emergency department visit, or hospitalization.
3. Treatment strategy in which LABDs were held by the treating medical team (SABD-only approach).
4. Participant already performed spirometry on the same day of testing.
5. Inability to provide informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Long-acting bronchodilator therapy (LABD); Long-acting inhaler therapy; Drug: Short-acting bronchodilator therapy (SABD); Short-acting inhaler therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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)	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).

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: MEI/MES I&P Program (McGill University, Thorasys Inc.)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Bronchodilator Agents
• Other Study ID Numbers: 2024-10445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No