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

NCT ID: NCT06495047

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-19
• Study Completion Date: 2025-12-31

Brief 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.

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.

Conditions

COPD; COPD Exacerbation Acute

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Long-acting bronchodilator therapy (LABD)

Intervention Type: DRUG

Long-acting inhaler therapy

Short-acting bronchodilator therapy (SABD)

Intervention Type: DRUG

Short-acting inhaler therapy

Interventions

Long-acting bronchodilator therapy (LABD)

Long-acting inhaler therapy

Intervention Type: DRUG

Short-acting bronchodilator therapy (SABD)

Short-acting inhaler therapy

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MEI/MES I&P Program (McGill University, Thorasys Inc.)

UNKNOWN

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Bryan Ross

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Bryan A. Ross, MD, FRCPC, MSc (Epi, Physiol)

Role: CONTACT

bryan.ross@mcgill.ca

(514) 843-1465

Facility Contacts

Bryan A Ross, MD, FRCPC, MSc (Epi, Physiol)

Role: primary

bryan.ross@mcgill.ca

514-934-1934

Other Identifiers

2024-10445

Identifier Type: -

Identifier Source: org_study_id