AsthmaNCT03148210
Undiagnosed COPD and Asthma Population Study (UCAP)
A study testing Treatment strategy using evidence-based guidelines for asthma or COPD, Smoking Cessation and Participant Education in people with Asthma and COPD, run by Ottawa Hospital Research Institute at 15 sites in Canada.
Trial summary
Previous population health studies suggest that up to 10% of Canadian adults have undiagnosed asthma or COPD- these people are currently undiagnosed and untreated, even though they may have significant respiratory symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Treatment strategy using evidence-based guidelines for asthma or COPD, Smoking Cessation and Participant Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 508 participants
- Where
- 15 sitesCanada
- Study dates
- 5 Jun 2017to 9 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects at least 18 years old;
- Subjects who score > or = to 6 points on The Asthma Screening Questionnaire or > 19.5 points on The COPD Diagnostic Questionnaire;
- Subjects who have given written informed consent to participate in this trial in accordance with local regulations;
- Subjects able to perform pre and post bronchodilator spirometry to measure lung function;
- Additional Inclusion Criteria for RCT:
- Those subjects who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose FEV1 improves by > 12% and 200 ml after bronchodilator and COPD will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to consent and participate in the RCT.
Who cannot join
- Subjects who report a previous physician diagnosis of asthma.
- Subjects who report a previous physician diagnosis of COPD
- Subjects with any of the following conditions within the past 3 months: Heart attack or hospitalization for other heart problems; Stroke; Aortic or cerebral aneurysm; Detached retina or eye surgery
- Subjects who are in the third trimester of pregnancy
- Subjects involved in another interventional trial
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
University of Calgary
Calgary, Alberta, T2N 4N1
University of Alberta
Edmonton, Alberta, T6G 2C8
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Firestone Institute for Respiratory Health
Hamilton, Ontario, L8N 4A6
Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Health Sciences Centre
London, Ontario, N6A 5W9
The Research Institute of the McGill University Health Centre (RI-MUHC)
Montreal, Quebec, H3H 2R9
Hopital du Scaré-Coeur
Montreal, Quebec, H4J 1C5
The Ottawa Hospital-General Campus
Ottawa, Ontario, K1H 8L6
IUCP, Hôpital Laval
Québec, Quebec, G1V 4G5
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
St. Clare's Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8
St. Micheal's Hospital
Toronto, Ontario, M5B 1W8
Vancouver General Hospital- The Lung Centre
Vancouver, British Columbia, V5Z 1M9
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Randomized, Controlled, Clinical Trial to Address the Burden of Undiagnosed Airflow Obstruction in Canadian Adults
Previous population health studies suggest that up to 10% of Canadian adults have undiagnosed asthma or COPD- these people are currently undiagnosed and untreated, even though they may have significant respiratory symptoms. Our study will use targeted casefinding to find people with undiagnosed asthma and COPD in Canadian communities. The investigators will assess their symptoms and their health care use and number of sick days to determine the burden of undiagnosed respiratory disease in these people. The investigators will then determine whether early treatment of previously undiagnosed airflow obstruction will improve patients' health outcomes.
- Being tested
- Treatment strategy using evidence-based guidelines for asthma or COPD, Smoking Cessation, Participant Education
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment strategy using evidence-based guidelines for asthma or COPDDrug
The respirologist will determine the clinical extent of the patient's symptoms, activity limitation, and degree of airflow obstruction and will commence the subject on asthma or COPD medications if indicated
Smoking CessationBehavioural
Smoking cessation counselling by a qualified educator if currently smoking
Participant EducationBehavioural
Standardized education for asthma or COPD disease
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Care | Active comparator | Treatment strategy using evidence-based guidelines for asthma or COPD Receives: Drug: Treatment strategy using evidence-based guidelines for asthma or COPD; Behavioral: Smoking Cessation; Behavioral: Participant Education |
| Standard of Care | Placebo comparator | Spirometry result sent to family MD Receives: Behavioral: Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual rate of patient initiated healthcare utilization events for respiratory illness
Number of visits for respiratory illnesses divided by the length of time in the study
Measured: 12 months
Secondary outcomes (5)
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 months in comparison to the lung function measurements on the day of randomization.
Measured: 12 months
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 months 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 months
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 months 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 months
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 months 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 months
Smoking cessation rate
The number of participants who quit smoking over the 12 month period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start5 Jun 2017
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148210
- Sponsor's protocol ID
- 20170182-01H
- Status last verified
- Mar 2024
- First submitted
- 8 May 2017
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aaron SD, Vandemheen KL, Whitmore GA, Bergeron C, Boulet LP, Cote A, McIvor RA, Penz E, Field SK, Lemiere C, Mayers I, Bhutani M, Azher T, Lougheed MD, Gupta S, Ezer N, Licskai CJ, Hernandez P, Ainslie M, Alvarez GG, Mulpuru S; UCAP Investigators. Early Diagnosis and Treatment of COPD and Asthma - A Randomized, Controlled Trial. N Engl J Med. 2024 Jun 13;390(22):2061-2073. doi: 10.1056/NEJMoa2401389. Epub 2024 May 19.
PubMed 38767248
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Clinical Trial to Address the Burden of Undiagnosed Airflow Obstruction in Canadian Adults
- ClinicalTrials.gov ID
- NCT03148210
- Acronym / sponsor ID
- 20170182-01H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 10 May 2017 (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.
Previous population health studies suggest that up to 10% of Canadian adults have undiagnosed asthma or COPD- these people are currently undiagnosed and untreated, even though they may have significant respiratory symptoms. Our study will use targeted casefinding to find people with undiagnosed asthma and COPD in Canadian communities. The investigators will assess their symptoms and their health care use and number of sick days to determine the burden of undiagnosed respiratory disease in these people. The investigators will then determine whether early treatment of previously undiagnosed airflow obstruction will improve patients' health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Care | Active comparator | Drug: Treatment strategy using evidence-based guidelines for asthma or COPD, Behavioral: Smoking Cessation, Behavioral: Participant EducationTreatment strategy using evidence-based guidelines for asthma or COPD |
| Standard of Care | Placebo comparator | Behavioral: Smoking CessationSpirometry result sent to family MD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects at least 18 years old;
- Subjects who score > or = to 6 points on The Asthma Screening Questionnaire or > 19.5 points on The COPD Diagnostic Questionnaire;
- Subjects who have given written informed consent to participate in this trial in accordance with local regulations;
- Subjects able to perform pre and post bronchodilator spirometry to measure lung function;
- Those subjects who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose FEV1 improves by > 12% and 200 ml after bronchodilator and COPD will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to consent and participate in the RCT.
Key exclusion criteria (5 listed)
- Subjects who report a previous physician diagnosis of asthma.
- Subjects who report a previous physician diagnosis of COPD
- Subjects with any of the following conditions within the past 3 months: Heart attack or hospitalization for other heart problems; Stroke; Aortic or cerebral aneurysm; Detached retina or eye surgery
- Subjects who are in the third trimester of pregnancy
- Subjects involved in another interventional trial
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 |
|---|---|---|
| Treatment strategy using evidence-based guidelines for asthma or COPDThe respirologist will determine the clinical extent of the patient's symptoms, activity limitation, and degree of airflow obstruction and will commence the subject on asthma or COPD medications if indicated | Drug | Enhanced Care |
| Smoking CessationSmoking cessation counselling by a qualified educator if currently smoking | Behavioural | Enhanced Care, Standard of Care |
| Participant EducationStandardized education for asthma or COPD disease | Behavioural | Enhanced Care |
Primary outcome
Annual rate of patient initiated healthcare utilization events for respiratory illness
Time frame: 12 months
Number of visits for respiratory illnesses divided by the length of time in the study
5 secondary outcomes
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 months
Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire
Time frame: 12 months
Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).
Time frame: 12 months
Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)
Time frame: 12 months
Smoking cessation rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Derived from this study: PubMed 38767248Aaron SD, Vandemheen KL, Whitmore GA, Bergeron C, Boulet LP, Cote A, McIvor RA, Penz E, Field SK, Lemiere C, Mayers I, Bhutani M, Azher T, Lougheed MD, Gupta S, Ezer N, Licskai CJ, Hernandez P, Ainslie M, Alvarez GG, Mulpuru S; UCAP Investigators. Early Diagnosis and Treatment of COPD and Asthma - A Randomized, Controlled Trial. N Engl J Med. 2024 Jun 13;390(22):2061-2073. doi: 10.1056/NEJMoa2401389. Epub 2024 May 19.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment strategy using evidence-based guidelines for asthma or COPD, Smoking Cessation and Participant Education in people with Asthma and COPD, run by Ottawa Hospital Research Institute at 15 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual rate of patient initiated healthcare utilization events for respiratory illness (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148210, which also lists 1 linked publication.
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 7 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.