Early Diagnosis and Treatment for Asthma or COPD
(UCAP2 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ottawa Hospital Research Institute
Must not be taking: Inhaled corticosteroids, Long-acting bronchodilators
Disqualifiers: Asthma, COPD, Lung cancer, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Our research group has found that Canadians with undiagnosed asthma or chronic obstructive pulmonary disease (COPD) have increased respiratory symptoms and worse health-related quality of life.
The investigators recently developed and validated an on-line questionnaire to accurately identify these symptomatic, undiagnosed individuals.
The investigators will advertise in the community asking individuals to complete the on-line questionnaire at home, at their leisure, to determine if they are at risk of asthma or COPD. Those at risk will be invited to participate in a randomized, controlled clinical trial to determine whether early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by the primary care practitioner will improve their quality of life.
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 data supports the effectiveness of early diagnosis and treatment for asthma or COPD?
Research shows that early diagnosis and treatment of COPD can help reduce the severity and progression of the disease, improve quality of life, and decrease hospital visits. Early management, including lifestyle changes like quitting smoking and addressing symptoms, is crucial for better outcomes.
12345What safety data exists for early diagnosis and treatment of asthma or COPD?
Some studies have looked at the safety of asthma and COPD treatments. For asthma, many patients report side effects like tiredness and palpitations (feeling your heart beat fast). For COPD, inhaled medications can sometimes cause serious side effects that lead to emergency room visits.
678910How is the early diagnosis and treatment for asthma or COPD different from other treatments?
This treatment focuses on diagnosing and managing asthma or COPD as early as possible, which can help prevent the progression of the disease. Early intervention, including lifestyle changes like smoking cessation and managing symptoms, is emphasized to improve long-term outcomes.
1231112Eligibility Criteria
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 18 years old or older.
I am experiencing symptoms related to my breathing.
+3 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Early diagnosis of previously undiagnosed asthma or COPDExperimental Treatment1 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 COPDActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ottawa Hospital General CampusOttawa, Canada
Loading ...
Who Is Running the Clinical Trial?
Ottawa Hospital Research InstituteLead Sponsor
References
Initial diagnosis and management of chronic obstructive pulmonary disease in Australia: views from the coal face. [2018]Early diagnosis and management can mitigate the long-term morbidity and mortality of chronic obstructive pulmonary disease (COPD).
Earlier diagnosis and earlier treatment of COPD in primary care. [2021]Chronic obstructive pulmonary disease (COPD) is a progressive disease that begins many years before a diagnosis is usually made. The need for an early and confirmed diagnosis of COPD is increasingly appreciated by primary care physicians in whose hands the ability to make improvements in early diagnosis largely rests. Case-finding of patients with symptoms of lifestyle limitation is probably the most practical way to achieve early diagnosis. Evidence suggests a burden of early COPD on afflicted people and their families. Early encouragement of smoking cessation, in conjunction with management of symptoms and treating activity limitation and exacerbations by appropriate non-pharmacologic and pharmacologic management at the earliest possible stage, could positively affect the impact and progression of the disease.
Factors that delay COPD detection in the general elderly population. [2011]In patients with COPD, early detection and rapid treatment are essential to prevent its progression and exacerbations.
Patients' experience of identifying and managing exacerbations in COPD: a qualitative study. [2019]Effective self-management in chronic obstructive pulmonary disease (COPD) is crucial to reduce hospital admissions and improve outcomes for patients. This includes early detection and treatment of exacerbations by patients themselves.
[Management of COPD according to severity by respiratory specialists in France]. [2019]The diagnosis and treatment of chronic obstructive pulmonary disease (COPD) is suboptimal in many patients, which may impact on morbidity, mortality, use of healthcare resources and patients' overall quality of life.
Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. [2021]As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals.
Inhalation therapies in COPD - adverse drug reactions impact on emergency department presentations. [2023]Inhaled drugs have been cornerstones in the treatment of chronic obstructive pulmonary disease (COPD) for decades and show a high prescription volume. Due to the local application, drug safety issues of these therapies are often underestimated by professionals and patients. Data about adverse drug reactions (ADRs) caused by inhaled therapy in patients with COPD and polypharmacy are rare. We aimed to analyze the use and relevance of inhaled therapies in those patients in relation to ADR complaints, which were severe enough to warrant presentation to the emergency department.
Comparative safety of inhaled medications in patients with chronic obstructive pulmonary disease: systematic review and mixed treatment comparison meta-analysis of randomised controlled trials. [2022]The active-treatment comparative safety information for all inhaled medications in patients with chronic obstructive pulmonary disease (COPD) is limited. We aimed to compare the risk of overall and cardiovascular death for inhaled medications in patients with COPD.
Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the West Wales Adverse Drug Reaction Profile. [2021]To assess the clinical effect of medication monitoring using the West Wales Adverse Drug Reaction (ADR) Profile for Respiratory Medicine.
Patient-reported adverse events under asthma therapy: a community pharmacy-based survey. [2015]The characteristics of patients who report adverse events (AEs) attributed to asthma therapy have been little investigated. Asthma patients aged 18-50 years were surveyed in pharmacies. Patients completed a questionnaire linked to computerized records of dispensed medications. Patients reported all AEs that they attributed to asthma therapy. The correlates of reporting 2+ AEs were identified. Almost 59% of the 1,351 patients (mean age: 37, 56% females) attributed AEs to asthma therapy, and 35% at least two. Most common AEs included tiredness (21.8%) and palpitations (21.1%). Poor asthma control and perception of asthma as a handicap were the major correlates of reporting 2+ AEs (odds ratio (OR)=2.5, 95% confidence interval (CI)=[1.7-3.7] and OR=1.9, 95% CI=[1.4-2.5]). Other significant correlates included age >30 years, female gender, and receiving psychotropic therapy. Inadequate control may partly account for AEs attributed by patients to asthma therapy. Improving patients' education may help to improve acceptability of asthma therapy.
[Early diagnosis of chronic obstructive pulmonary disease (COPD)]. [2006]Since the early detection of COPD is problematic, nonobstructed smokers with a chronic productive cough are initially assigned to the COPD risk group o. Although there is still a lack of evidence that early pharmacological intervention is associated with benefits in terms of disease progression, the earliest possible diagnosis is still considered a desirable goal. For the sooner triggering noxae, such as cigarette smoke, are eliminated, the more positive are the effects on the subsequent course of the illness. When establishing the diagnosis, a careful case history is of particular importance. With the aid of various diagnostic pulmonary function tests, degrees of severity can be differentiated and the course of COPD can be determined. Since the end of 2004, structured therapeutic programs for COPD have become available.
Difficulties in differential diagnosis of COPD and asthma in primary care. [2021]Chronic obstructive pulmonary disease (COPD) and asthma treatment must be based on appropriate diagnosis. However, patients receiving inhaled therapy in primary care may not be accurately diagnosed according to current guidelines.