Back to resultsThe UCAP 2 Pilot Study
Primary Purpose
COPD, Asthma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD
Sponsored by
About this trial
This is an interventional diagnostic trial for COPD
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- Ottawa Hospital General Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Early diagnosis and treatment of COPD or Asthma
Delayed diagnosis and treatment of COPD or Asthma
Arm Description
Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant on the day of randomization
Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant at 12 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Differences between groups in patient-initiated healthcare utilization events for respiratory illness over the 12-week trial period.
Full Information
NCT ID
NCT06014840
First Posted
July 31, 2023
Last Updated
August 24, 2023
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT06014840
Brief Title
The UCAP 2 Pilot Study
Official Title
Early Diagnosis and Treatment of Undiagnosed COPD or Asthma: The UCAP 2 Trial - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Asthma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early diagnosis and treatment of COPD or Asthma
Arm Type
Active Comparator
Arm Description
Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant on the day of randomization
Arm Title
Delayed diagnosis and treatment of COPD or Asthma
Arm Type
Other
Arm Description
Treatment strategy using evidence-based guidelines for asthma or COPD provided to participant at 12 weeks.
Intervention Type
Other
Intervention Name(s)
Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD
Intervention Description
Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD
Primary Outcome Measure Information:
Title
Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes
Description
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.
Time Frame
12 weeks
Title
Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)
Description
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.
Time Frame
12 weeks
Title
Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI)
Description
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.
Time Frame
12 weeks
Title
Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire
Description
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.
Time Frame
12 weeks
Title
Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.
Description
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.
Time Frame
12 weeks
Title
Differences between groups in patient-initiated healthcare utilization events for respiratory illness over the 12-week trial period.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shawn Aaron
Phone
613-737-8899
Ext
74729
Email
saaron@ohri.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Vandemheen
Phone
613-737-8259
Email
kvandemheen@toh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy Vandemheen
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Vandemheen, RN, MScN
Phone
613-737-8259
Email
kvandemheen@toh.ca
First Name & Middle Initial & Last Name & Degree
Susan Deveau, RRT
Phone
613-737-8899
Ext
74765
Email
sdeveau@ohri.ca
First Name & Middle Initial & Last Name & Degree
Shawn Aaron, MD
First Name & Middle Initial & Last Name & Degree
Sunita Mulpuru, MD
12. IPD Sharing Statement
Learn more about this trial
The UCAP 2 Pilot Study
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