The UCAP 2 Pilot Study

NCT06014840 | Withdrawn

• 1 other identifier: 2023
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (6)

• Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes

  12 weeks

• Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)

  12 weeks

• Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI)

  12 weeks

• Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire

  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.

  12 weeks

Study Arms (2)

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

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.

Other: Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD

Interventions

Assessment and Treatment provided to participant by a respirologist using evidence-based guidelines for asthma or COPD 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; Early diagnosis and treatment of COPD or Asthma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Kathy Vandemheen

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 28, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

CA (1)