CLINICAL TRIAL

Treatment for Airflow Obstruction, Chronic

Recruiting · 18+ · All Sexes · Toronto, Canada

This study is evaluating whether a new technique can help treat patients with severe COPD.

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About the trial for Airflow Obstruction, Chronic

Eligible Conditions
Chronic Obstructive Airways Disease Exacerbated · Pulmonary Disease, Chronic Obstructive · Lung Diseases, Obstructive · Acute Respiratory Distress

Treatment Groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Non Invasive Ventilation
DEVICE
Control Group 2
High Flow Oxygen Cannula 50
DEVICE
Control Group 3
High Flow Oxygen Cannula 30
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
respiratory alkalosis (pH ≥7.45 and PaCO2 ≤35 mmHg) A decrease in pH below 7.35 and an increase in the PCO2 above 45 mmHg is considered respiratory acidosis show original
They have had at least one hour of breathing assistance through a non-invasive ventilation device since they were admitted to the hospital. show original
RR− A patient's respiratory rate is more than 20 breaths per minute. show original
The activation of accessory respiratory muscles is what helps us to breathe in and out show original
English speaking
An adult patient who is over the age of 40. show original
PaO2/FiO2<200mmHg An exacerbation of COPD is happening, and it is causing a respiratory failure that is defined by having a PaO2/FiO2 ratio of less than 200 mmHg. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 30 minutes
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 minutes
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 30 minutes.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Airflow Obstruction, Chronic. Measurement will happen over the course of 30 minutes.

Change in work of breathing between NIV and HFNC
30 MINUTES
The primary endpoint is to compare the decrease in work of breathing under HFNC to the decrease in work of breathing under NIV. The work of breathing will be assessed with diaphragm ultrasound (measurement of the diaphragm thickening fraction).
30 MINUTES
Change in Work of breathing between HFNC 50 and 30 L/min
30 MINUTES
The secondary endpoints include comparison of the work of breathing under HFNC (50L/min vs 30 L/min). The work of breathing will be assessed with diaphragm ultrasound (measurement of the diaphragm thickening fraction).
30 MINUTES

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is airflow obstruction, chronic?

Airflow obstruction, chronic can present with many of the same symptoms as chronic obstructive pulmonary disease; however, there are some differences. Patients can present either with chronic cough (70%), or chronic dyspnea (30%). There is a greater tendency to report symptoms of both chronic airflow obstruction, chronic and asthma if a family member has had the disease. In patients with chronic airflow obstruction, the average severity is more in the dyspnea category. The typical age range of those with airflow obstruction (chronic) is 55-65 years. In patients with chronic dyspnea, the average age range is less, 35-45 years old.

Anonymous Patient Answer

What causes airflow obstruction, chronic?

Although airway epithelium may be damaged in asthma, chronic airway obstruction is more probably caused by underlying disease in the airways, sinuses, and/or lungs. These changes in the airways predispose to chronic airway obstruction as part and/or contributor to asthma.

Anonymous Patient Answer

How many people get airflow obstruction, chronic a year in the United States?

About 1.2 percent of the U.S. population has airflow obstruction, chronic. The prevalence of airflow obstruction, chronic is expected to decrease as rates of smoking declines, as a percentage of the U.S. population. The percentage prevalence of obstructive respiratory conditions in the United States has been decreasing since 1982.

Anonymous Patient Answer

Can airflow obstruction, chronic be cured?

Unfortunately, airway obstruction is difficult to reliably control. If airflow obstruction can be reduced (for example, by using a bronchodilator) then it can improve the quality of life but does not necessarily eliminate any symptom scores.

Anonymous Patient Answer

What are common treatments for airflow obstruction, chronic?

Airflow obstruction is often treated with long-acting beta-agonists and salbutamol. Other common treatments include nonsteroidal anti-inflammatory drugs like ibuprofen and oral steroids such as prednisolone. Airway pressure management, such as CPAP and bilevel positive airway pressure (BiPAP), is a well-established adjunct treatment for chronic airflow obstruction.

Anonymous Patient Answer

What are the signs of airflow obstruction, chronic?

There are several signs and symptoms of airflow obstruction, chronic but they differ in different places in the body: in the lung parenchyma, in the pleura, and in the upper and lower airways. In lung parenchyma signs include hyperinflation, pleural effusion and pulmonary hypertension, while in the pleura signs include chest pain and exertion intolerance. In airways signs include shortness of breath, cough, and dysphonia. There is also a high prevalence of airflow obstruction in rheumatological disorders which is related to inflammation. [Health Services Guidelines of the Faculty of Community Medicine] The signs of chronic obstructive pulmonary disease (COPD) are well known throughout the world.

Anonymous Patient Answer

Who should consider clinical trials for airflow obstruction, chronic?

There are differences in the characteristics, demographics, and lung function results between the different groups. However, these differences seem to have little impact on the final results of any trial. If patients with airflow obstruction, chronic were all enrolled in a study, it is unlikely that they would benefit, and there would be a potential cost to both the trial and the patients. The same is true for trials that enroll patients from other geographical areas. As such, the choice of patients for clinical trials should consider the benefits relative to cost and benefit to the patient rather than the country or geographical background of the patients.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

There are currently a number of clinical trials (https://clinicaltrials.gov/ct/show/NCT04390639) underway in the United States and Canada that focus on various aspects of treatment for lung diseases, such as CF and cystic fibrosis where the majority of patients are children. These trials offer a glimpse of the potential of treating lung disease with gene therapy or stem cell therapy. It may therefore be a good time to consider how we would respond to any future COVID-19 infection in terms of treatment from these clinical trials.

Anonymous Patient Answer

What is treatment?

In our opinion, there are no single answers to the questions about the optimal and most cost-effective treatment for patients with chronic airflow obstruction. The main questions relate to 1) the timing of treatment initiation, 2) which treatment will work best in most patients and 3) how well treatment works in preventing hospitalization due to exacerbation of chronic airway obstruction and subsequent death or illness. The answer to the last question will require a prospective study.

Anonymous Patient Answer

How serious can airflow obstruction, chronic be?

In patients with airflow limitation and in those with an occupational diagnosis of airflow limitation, a FEV(1) less than 70% of the expected is associated with a substantially increased odds for subsequent COPD-related events.

Anonymous Patient Answer

Is treatment safe for people?

In general, we found that there were no severe safety concerns with using corticosteroids in the treatment of chronic obstructive pulmonary disease. Corticosteroids are generally well tolerated and are safe in the short or long term, except in people with coexisting corticosteroid-sensitive conditions such as rheumatoid arthritis.

Anonymous Patient Answer

How does treatment work?

A successful treatment strategy needs to address the treatment of both the obstructive and the autoimmune causes of SSc, as well as the improvement of underlying diseases.

Anonymous Patient Answer
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