COPDUCAP2NCT06392776
Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL
A study testing Early diagnosis and treatment in people with COPD and Asthma, run by Ottawa Hospital Research Institute at 6 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Early diagnosis and treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 6 sitesCanada
- Study dates
- 16 Jul 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals at least 18 years old
- Individuals must be symptomatic with respiratory symptoms
- Individuals must complete the UCAP-Q questionnaire and score a ≥ 6% probability of having either asthma or COPD.
- Individuals who have given written informed consent to participate in this trial in accordance with local regulations;
- Individual must be able to perform pre and post bronchodilator spirometry to measure lung function
- Additional Inclusion Criteria for the Randomized Controlled Trial (RCT):
- Individuals who have undiagnosed airflow obstruction on spirometry testing (i.e. Asthma or COPD) will be asked to participate in the RCT.
Who cannot join
- Individuals who report a previous diagnosis of asthma, COPD, history of lung cancer, bronchiectasis, interstitial lung disease, cystic fibrosis or other significant diagnosed lung disease.
- Individuals currently under the care of a Respirologist.
- Individuals currently using inhaled corticosteroids or long-acting bronchodilators.
- Individuals with history of myocardial infarction, stroke, aortic or cerebral aneurysm, or detached retina or eye surgery within the past 3 months (spirometry is contraindicated)
- Individuals who are in the third trimester of pregnancy
- Individuals involved in another interventional trial
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Recruiting
St. Joseph's Hamilton Healthcare
Hamilton, Ontario, L8N 4A6
Andrew McIvor, MD
613-905-522-1155 ext. 35121, ljohnson@stjosham.on.ca
- Recruiting
Kingston Health Sciences Centre/Queen's University
Kingston, Ontario, K7L 2V6
M. Diane Lougheed, MD, Diane.Lougheed@kingstonhsc.ca
Alison Morra, Tel 613 549-6666 x2762, Alison.Morra@kingstonhsc.ca
- Recruiting
Ottawa Hospital General Campus
Ottawa, Ontario, K1H 8L6
Kathy Vandemheen, 613-737-8259, kvandemheen@toh.ca
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
Andréanne Côté, MD
Geneviève Parent-Racine, MSc, 418-656-8711 ext. 2617, genevieve.parent-racine@criucpq.ulaval.ca
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan
Erika Penz, MD
Britany Duncan, MPH, (306) 966-6230, britney.duncan@usask.ca
- Recruiting
St. Michael's Hospital/Unity Health Toronto
Toronto, Ontario
Samir Gupta, MD, Samir.Gupta@unityhealth.to
Venuzshaa Selvanayagam, Venuzshaa.Selvanayagam@unityhealth.to
About this study
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.
- Being tested
- Early diagnosis and treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early diagnosis and treatmentOther
Early diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by a primary care practitioner
| Study group | Role | What they receive |
|---|---|---|
| Early diagnosis of previously undiagnosed asthma or COPD | Experimental | 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 Receives: Other: Early diagnosis and treatment |
| Delayed diagnosis of previously undiagnosed asthma or COPD | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).
The change in disease-specific quality of life will be expressed as the total St. George's Respiratory Questionnaire score at 12 weeks minus the score on the day of randomization. This questionnaire includes 3 domains: symptoms (distress caused by specific respiratory symptoms); activity (physical activities that cause or are limited by breathlessness); and impact (social and psychological effects of the respiratory disease). A total change of - 4 points in the SGRQ total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate poor health status.
Measured: 12 weeks
Secondary outcomes (6)
Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)
The change in overall respiratory symptom burden will be expressed as the total score of the COPD Assessment Test at 12 weeks minus the score on the day of randomization. A total change of - 2 points in the CAT total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate higher burden.
Measured: 12 weeks
Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.
The change will be expressed as the mean change in the FEV1 measurements at 12 weeks in comparison to the lung function measurements on the day of randomization.
Measured: 12 weeks
Differences between the experimental group and the control group in patient-initiated urgent healthcare utilization events for respiratory illness over the 12-week trial period.
Differences between groups in patient-initiated urgent healthcare utilization events for respiratory illness over the 12-week trial period.
Measured: 12 weeks
Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes
The baseline dyspnea index (BDI) is used to rate the severity of dyspnea at a single point in time and the transitional dyspnea index (TDI) is used to assess change in dyspnea at 12 weeks.
The differences between the experimental group and the control group TDI measured at 12 weeks.
Measured: 12 weeks
Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI)
The change in absenteeism and presenteeism will be assessed over the 12 week study period. Higher scores indicate greater impairment in work productivity and daily activities
Measured: 12 weeks
Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire
The change in general health status will be expressed as the total score of the SF-36 Health Survey Questionnaire at 12 weeks minus the score on the day of randomization. A total change of 8-10 points in the SF-36 has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate better health status.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start16 Jul 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shawn Aaron, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392776
- Sponsor's protocol ID
- Protocol ID 4373
- Acronym
- UCAP2
- Status last verified
- Sep 2026
- First submitted
- 26 Apr 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis and Treatment of Undiagnosed Asthma or COPD: THE UCAP 2 TRIAL
- ClinicalTrials.gov ID
- NCT06392776
- Acronym / sponsor ID
- UCAP2 / Protocol ID 4373
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early diagnosis of previously undiagnosed asthma or COPD | Experimental | Other: Early diagnosis and treatmentOn 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 |
| Delayed diagnosis of previously undiagnosed asthma or COPD | No 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals at least 18 years old
- Individuals must be symptomatic with respiratory symptoms
- Individuals must complete the UCAP-Q questionnaire and score a ≥ 6% probability of having either asthma or COPD.
- Individuals who have given written informed consent to participate in this trial in accordance with local regulations;
- Individual must be able to perform pre and post bronchodilator spirometry to measure lung function
Key exclusion criteria (6 listed)
- Individuals who report a previous diagnosis of asthma, COPD, history of lung cancer, bronchiectasis, interstitial lung disease, cystic fibrosis or other significant diagnosed lung disease.
- Individuals currently under the care of a Respirologist.
- Individuals currently using inhaled corticosteroids or long-acting bronchodilators.
- Individuals with history of myocardial infarction, stroke, aortic or cerebral aneurysm, or detached retina or eye surgery within the past 3 months (spirometry is contraindicated)
- Individuals who are in the third trimester of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early diagnosis and treatmentEarly diagnosis of previously undiagnosed asthma or COPD and subsequent treatment by a primary care practitioner | Other | Early diagnosis of previously undiagnosed asthma or COPD |
Primary outcome
Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).
Time frame: 12 weeks
The change in disease-specific quality of life will be expressed as the total St. George's Respiratory Questionnaire score at 12 weeks minus the score on the day of randomization. This questionnaire includes 3 domains: symptoms (distress caused by specific respiratory symptoms); activity (physical activities that cause or are limited by breathlessness); and impact (social and psychological effects of the respiratory disease). A total change of - 4 points in the SGRQ total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate poor health status.
6 secondary outcomes
Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)
Time frame: 12 weeks
Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.
Time frame: 12 weeks
Differences between the experimental group and the control group in patient-initiated urgent healthcare utilization events for respiratory illness over the 12-week trial period.
Time frame: 12 weeks
Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes
Time frame: 12 weeks
Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: 12 weeks
Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shawn Aaron, MD principal investigator
Ottawa Hospital Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early diagnosis and treatment in people with COPD and Asthma, run by Ottawa Hospital Research Institute at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shawn Aaron, MD (6137378259, saaron@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ). (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.