Early Diagnosis and Treatment for Asthma or COPD

(UCAP2 Trial)

Recruiting at 4 trial locations

Overseen By Shawn Aaron, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Inhaled corticosteroids, Long-acting bronchodilators

Disqualifiers: Asthma, COPD, Lung cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early diagnosis and immediate treatment of asthma or COPD can improve quality of life. Participants will first complete an online questionnaire to assess their risk for these lung conditions. Those who score high on the risk questionnaire and have undiagnosed breathing problems may qualify to join. Participants should exhibit noticeable respiratory symptoms but must not have been previously diagnosed or treated for asthma or COPD. The trial will compare early diagnosis and treatment with a delayed approach to evaluate which is more effective. As an unphased trial, this study offers participants the chance to contribute to valuable research that could lead to earlier and more effective treatments for respiratory conditions.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes people who are currently using inhaled corticosteroids or long-acting bronchodilators. If you're using these, you might not be eligible to participate.

What prior data suggests that this protocol is safe for early diagnosis and treatment of asthma or COPD?

Research has shown that diagnosing and treating asthma or COPD early can be safe. One study found that people who received an early diagnosis and treatment experienced fewer health problems than those who did not. Another study demonstrated that even with regular care following an early diagnosis, health still improved. This suggests that early treatment is not only helpful but also generally well-tolerated. Although the specific trial you might join lacks detailed safety data at this time, findings from other studies offer some reassurance about the safety of early diagnosis and treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on the timing of diagnosis and treatment for asthma or COPD. Unlike the traditional approach that often relies on symptom management and delayed diagnosis, this trial emphasizes early diagnosis through spirometry and immediate communication with primary-care practitioners. The goal is to empower both patients and doctors with timely information, potentially leading to quicker intervention and better management of these conditions. This proactive strategy could transform how asthma and COPD are managed, possibly improving outcomes and quality of life for patients.

What evidence suggests that early diagnosis and treatment might be effective for asthma or COPD?

This trial will compare early diagnosis and treatment with delayed diagnosis for previously undiagnosed asthma or COPD. Research has shown that early diagnosis and treatment of asthma and COPD can greatly improve a patient's quality of life. Studies have found that patients who start treatment early experience fewer health issues than those who begin standard care later. Specifically, one study found that people who received early treatment had fewer health problems, with only 0.53 events per person each year compared to 1.12 in the usual care group. Early treatment also led to improvements that exceeded the smallest changes considered important. Catching and treating these conditions early helps prevent disease progression and lowers the risk of serious health problems. ^{2 6 7 8 9}

Who Is on the Research Team?

Shawn Aaron, MD

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for Canadian adults with respiratory symptoms who suspect they might have asthma or COPD. They must score at least a 6% chance of having these conditions on an online questionnaire and be able to perform lung function tests. Only those without a prior diagnosis will be considered.

Inclusion Criteria

I scored 6% or higher for asthma or COPD risk on the UCAP-Q.

I am experiencing symptoms related to my breathing.

I have signed the consent form to participate in this trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Online questionnaire completion

Treatment

Participants receive early or delayed diagnosis and treatment for asthma or COPD

12 weeks

Initial visit for randomization, follow-up visits as needed

Follow-up

Participants are monitored for changes in quality of life and respiratory symptoms

12 weeks

Final assessment visit at 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Early diagnosis and treatment

Trial Overview

The UCAP 2 TRIAL aims to see if early detection and treatment of undiagnosed asthma or COPD can improve patients' quality of life. Participants identified as at risk from an online survey are randomly chosen to receive primary care intervention.

How Is the Trial Designed?

Group I: Early diagnosis of previously undiagnosed asthma or COPD Experimental Treatment 1 Intervention

On the day of randomization the participant will receive a copy of their interpreted spirometry report with a listed diagnosis. This report will be sent to their primary-care practitioner. In addition to the spirometry interpretation, the primary-care practitioner will be provided with a brief one-page guideline-based tool providing advice for pharmacologic and non-pharmacologic treatment of newly diagnosed asthma or COPD. The primary-care practitioner will be encouraged to see the participant as soon as possible to provide care. The participant will similarly be encouraged to make an appointment with the primary-care practitioner as soon as possible to access care for their condition

Group II: Delayed diagnosis of previously undiagnosed asthma or COPD Active Control 1 Intervention

At the 12 week visit, participants randomized to the delayed diagnosis will complete the trial outcome assessments. After completing the 12 week final trial assessments they will be seen by the study respirologist and treated for their newly diagnosed asthma or COPD.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

A comprehensive analysis of 372,345 spontaneous reports from 2011 to 2017 identified 385 different safety signals related to asthma medications in children, with a notable focus on psychiatric events, highlighting the importance of monitoring these drugs in the pediatric population.

The study uncovered new safety signals, such as herpes viral infections linked to omalizumab and hypertrichosis associated with budesonide, emphasizing that age stratification is crucial for detecting unique risks in children that may not be evident in the broader population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. Baan, EJ., de Smet, VA., Hoeve, CE., et al.[2021]

The West Wales Adverse Drug Reaction (ADR) Profile significantly increased the identification of medication-related problems in patients with chronic respiratory diseases, with an average increase of 20.5 problems per participant compared to a decrease in the control group.

The use of the ADR Profile also led to a higher number of nursing actions taken, with a median increase of 2.5 actions per participant in the intervention group, suggesting it enhances medication management in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the West Wales Adverse Drug Reaction Profile. Gabe, ME., Murphy, F., Davies, GA., et al.[2021]

In a study of 269 COPD patients, 67% were using inhaled therapies, and 16% of these cases involved overdoses, leading to significant adverse drug reactions (ADRs) that required emergency department visits.

Overdosed inhaled therapies were associated with more frequent complaints of malaise and local symptoms, particularly linked to anticholinergics and beta-2 agonists, highlighting the need for better awareness and education regarding the risks of inhaled medications in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhalation therapies in COPD - adverse drug reactions impact on emergency department presentations. Bergs, I., Just, KS., Scholl, C., et al.[2023]

Chronic obstructive pulmonary disease (COPD) often develops silently over many years, making early diagnosis crucial for effective management, particularly in primary care settings.

Implementing case-finding strategies for patients showing lifestyle limitations and promoting early smoking cessation can significantly improve outcomes and slow disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Earlier diagnosis and earlier treatment of COPD in primary care. Price, D., Freeman, D., Cleland, J., et al.[2021]

Patients with chronic obstructive pulmonary disease (COPD) effectively identify exacerbations using both visible symptoms (like cough) and invisible symptoms (like chest sensations), demonstrating a combination of objective and subjective assessment methods.

The study highlights the importance of integrating patients' self-management strategies and their experiential knowledge into care plans, as they often manage exacerbations independently before seeking professional help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' experience of identifying and managing exacerbations in COPD: a qualitative study. Williams, V., Hardinge, M., Ryan, S., et al.[2019]

A survey of 233 Australian general practitioners revealed that while most diagnose COPD based on smoking history, symptoms, and spirometry, only 39.9% formally diagnosed COPD after the first symptoms, indicating a need for more proactive diagnosis.

Tiotropium was the preferred initial treatment for COPD among 77.3% of GPs, but only 27.5% routinely recommended pulmonary rehabilitation, highlighting a gap in the comprehensive management of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial diagnosis and management of chronic obstructive pulmonary disease in Australia: views from the coal face. Bereznicki, B., Walters, H., Walters, J., et al.[2018]

Early detection of Chronic Obstructive Pulmonary Disease (COPD) is crucial, especially for nonobstructed smokers with a chronic productive cough, as it can lead to better management and outcomes.

While there is currently no strong evidence that early pharmacological treatment significantly alters disease progression, eliminating triggers like cigarette smoke as soon as possible is believed to positively impact the course of the illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early diagnosis of chronic obstructive pulmonary disease (COPD)]. Gillissen, A., Juergens, UR., Menz, G.[2006]

In a study of 52,516 COPD patients across 42 trials, the tiotropium Soft Mist Inhaler was associated with a significantly increased risk of overall death compared to placebo and other inhaled medications, particularly for cardiovascular death in patients with severe COPD.

Among the inhaled treatments analyzed, the LABA-ICS combination showed the lowest risk of death, suggesting it may be a safer option for COPD management compared to the tiotropium Soft Mist Inhaler.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative safety of inhaled medications in patients with chronic obstructive pulmonary disease: systematic review and mixed treatment comparison meta-analysis of randomised controlled trials. Dong, YH., Lin, HH., Shau, WY., et al.[2022]

In a survey of 1,351 asthma patients aged 18-50, nearly 59% reported adverse events (AEs) related to their asthma therapy, with tiredness and palpitations being the most common symptoms.

Patients with poor asthma control and those who perceive their asthma as a handicap were significantly more likely to report multiple AEs, suggesting that better education and management of asthma could improve treatment acceptability and reduce reported side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported adverse events under asthma therapy: a community pharmacy-based survey. Laforest, L., Van Ganse, E., Devouassoux, G., et al.[2015]

In a study of 328 patients treated with inhaled corticosteroids in primary care, 40% had moderate to severe airflow obstruction, highlighting the need for accurate diagnosis of COPD and asthma.

The study found that there was a significant misdiagnosis rate, with 71.4% of COPD patients receiving inhaled corticosteroids and 12% of asthma patients not receiving them, indicating that misdiagnosis could lead to inadequate treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Difficulties in differential diagnosis of COPD and asthma in primary care. Miravitlles, M., Andreu, I., Romero, Y., et al.[2021]

In a study of 408 elderly individuals in rural Japan, those with COPD (60 participants) showed significantly poorer physical function and walking ability compared to matched healthy subjects, indicating that physical limitations can help identify COPD earlier.

Despite preserved walking endurance and quality of life in COPD patients, the lack of awareness about their condition delayed their motivation to seek medical care, highlighting the need for routine spirometry screening to facilitate early detection of COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that delay COPD detection in the general elderly population. Horie, J., Murata, S., Hayashi, S., et al.[2011]

In a study involving 2494 COPD patients across France, nearly 50% were classified as having severe to very severe disease, highlighting the significant burden of this condition.

Most patients (93.2%) were on pharmacological treatments, primarily bronchodilators and inhaled corticosteroids, but only 26.9% had access to pulmonary rehabilitation, indicating a gap in comprehensive care for COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of COPD according to severity by respiratory specialists in France]. Roche, N., Delclaux, B., Martinat, Y., et al.[2019]

Citations

1.

nejm.org

nejm.org/doi/10.1056/NEJMoa2401389

Early Diagnosis and Treatment of COPD and Asthma

The annualized rate of a primary-outcome event was lower in the intervention group than in the usual-care group (0.53 vs. 1.12 events per person ...

2.

journal.chestnet.org

journal.chestnet.org/article/S0012-3692(24)05278-4/fulltext

Early Diagnosis and Treatment of COPD and Asthma - CHEST

One-year improvements in all these outcomes within the intervention group exceeded known minimal clinically important differences. This study was the first to ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10363346/

Current Progress of COPD Early Detection: Key Points and ...

Patients with undiagnosed COPD are at increased risk of poor outcomes and a worsened quality of life, making early detection a crucial strategy ...

4.

atsjournals.org

atsjournals.org/doi/10.1164/rccm.202311-2120PP

Early Diagnosis and Treatment of Chronic Obstructive ...

An analysis of U.S. data demonstrated that among people with undiagnosed COPD, the risk for mortality over 20 years of follow-up was increased ( ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38767248/

Early Diagnosis and Treatment of COPD and Asthma

The annualized rate of a primary-outcome event was lower in the intervention group than in the usual-care group (0.53 vs. 1.12 events per person ...

6.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2401389

Early Diagnosis and Treatment of COPD and Asthma

Of 38,353 persons interviewed, 595 were found to have undiagnosed COPD or asthma and 508 underwent randomization: 253 were assigned to the intervention group ...

7.

rethinkingclinicaltrials.org

rethinkingclinicaltrials.org/news/grand-rounds-october-11-2024-early-diagnosis-and-treatment-of-asthma-and-copd-shawn-aaron-md/

Early Diagnosis and Treatment of Asthma and COPD ...

The trial results indicated that the health of people with asthma or COPD will still improve if they are diagnosed and receive the usual care.

8.

bmjopenrespres.bmj.com

bmjopenrespres.bmj.com/content/11/1/e002127

Real-world treatment trajectories of adults with newly ...

Real-world data from claims and EHRs indicate that first-line treatments of asthma and COPD vary widely across countries.

9.

nuvoair.com

nuvoair.com/blog/early-diagnosis-and-treatment-of-copd-and-asthma

Early Diagnosis and Treatment of COPD and Asthma

The primary aim of this study was to investigate if early identification and treatment of undiagnosed COPD and asthma could improve patient ...