COPDNCT06014840
The UCAP 2 Pilot Study
A study testing Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD in people with COPD and Asthma, run by Ottawa Hospital Research Institute at 1 site 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?
- Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2023to Dec 2028
- 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
- 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 (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose forced expiratory volume in 1 second (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 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
1 site in 1 country.
About this study
Official title: Early Diagnosis and Treatment of Undiagnosed COPD or Asthma: The UCAP 2 Trial - Pilot 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 our randomized, controlled clinical trial to determine if guidelines-based treatment of newly discovered undiagnosed asthma or COPD will improve their quality of life and clinical outcomes.
- Being tested
- Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD
- 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.
Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPDOther
Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD
| Study group | Role | What they receive |
|---|---|---|
| Early diagnosis and treatment of COPD or Asthma | Active comparator | Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant on the day of randomization Receives: Other: Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD |
| Delayed diagnosis and treatment of COPD or Asthma | Other | Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant at 12 weeks. Receives: Other: Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for 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)
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 transition dyspnea index (TDI) is used to assess changes from that baseline. The change in dyspnea will be expressed as the total score at 12 weeks minus the score on the day of randomization. A total change of more than 1 point in the score has been established as the minimal clinically important difference (MCID) for this questionnaire.
Measured: 12 weeks
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 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
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 groups in patient-initiated healthcare utilization events for respiratory illness over the 12-week trial period.
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 posted28 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Study was never started, no participants were enrolled. The protocol was significantly changed and current described study was abandoned.
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Kathy Vandemheen, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014840
- Sponsor's protocol ID
- 2023
- Status last verified
- Apr 2024
- First submitted
- 31 Jul 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis and Treatment of Undiagnosed COPD or Asthma: The UCAP 2 Trial - Pilot Study
- ClinicalTrials.gov ID
- NCT06014840
- Acronym / sponsor ID
- 2023
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started, no participants were enrolled. The protocol was significantly changed and current described study was abandoned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Aug 2023 (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 our randomized, controlled clinical trial to determine if guidelines-based treatment of newly discovered undiagnosed asthma or COPD will improve their quality of life and clinical outcomes.
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 and treatment of COPD or Asthma | Active comparator | Other: Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPDTreatment strategy using evidence-based guidelines for asthma or COPD provided to participant on the day of randomization |
| Delayed diagnosis and treatment of COPD or Asthma | Other | Other: Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPDTreatment strategy using evidence-based guidelines for asthma or COPD provided to participant at 12 weeks. |
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 |
|---|---|---|
| Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPDAssessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD | Other | Delayed diagnosis and treatment of COPD or Asthma, Early diagnosis and treatment of COPD or Asthma |
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
Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes
Time frame: 12 weeks
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 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
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 groups in patient-initiated healthcare utilization events for respiratory illness over the 12-week trial period.
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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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.
Kathy Vandemheen principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD in people with COPD and Asthma, run by Ottawa Hospital Research Institute at 1 site 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: withdrawn, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
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 25 Apr 2024.