Sustained Asthma Remission and Reduced RElapse Using a COmprehensive Management Strategy Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Eligibility Rate
研究概览
简要总结
The goal of this pilot clinical trial is to learn whether it is feasible to conduct a future larger trial of a comprehensive management strategy for adults with severe asthma who are starting biologic therapy.
The main questions this pilot study aims to answer are:
Can eligible participants be recruited and retained in the study? Can the study visits, tests, and other study procedures be successfully completed? Is the comprehensive management strategy acceptable to participants and clinicians? What proportion of participants receiving usual asthma care achieve asthma remission at 12 months?
Researchers will compare usual severe asthma care with a comprehensive management approach that uses specialized tests of airway inflammation and lung abnormalities to help doctors make treatment decisions.
Participants will be followed for 12 months. They will complete questionnaires, lung function tests, blood tests, and sputum testing. Clinically available CT scans obtained as part of usual care may also be used for study assessments. Participants may also choose to undergo optional research MRI scans.
详细描述
Current clinical assessments and conventional biomarkers have limited ability to predict which patients will respond most favorably to treatment.
This pilot randomized controlled trial will assess the feasibility of conducting a future full-scale randomized controlled trial evaluating whether specialized biomarkers of airway inflammation and lung abnormalities can better predict important asthma outcomes, including remission and relapse, than conventionally available biomarkers. The future full-scale trial will also evaluate whether a comprehensive management strategy guided by specialized biomarker assessments improves asthma outcomes compared with standard care.
Fifty adults with severe asthma who are initiating biologic therapy will be enrolled and randomized in a 1:1 ratio to either a standard of care group or a comprehensive management group. Participants assigned to the comprehensive management group will have treatment decisions informed by specialized biomarker results, while clinicians caring for participants in the standard of care group will remain blinded to specialized research biomarker results.
Participants will be followed for 12 months and will undergo study assessments that include asthma questionnaires, pulmonary function testing, fractional exhaled nitric oxide (FeNO) testing, blood biomarker assessments, and sputum cell analysis. Clinically available computed tomography (CT) imaging obtained as part of usual care may also be used for study assessments. Participants who consent to the optional magnetic resonance imaging (MRI) component may undergo research MRI assessments.
The findings from this pilot study will provide feasibility data and preliminary information regarding the utility of specialized biomarkers and biomarker-guided management strategies in severe asthma and will inform the design of the future full-scale randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will remain blinded to study arm allocation throughout the study. Clinicians are not blinded to study arm allocation because they will know whether specialized biomarker results are available to guide treatment decisions. Clinicians in the standard of care arm will be blinded to specialized biomarker results, while clinicians in the comprehensive management arm will have access to these results for clinical decision-making.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient understands study procedures and is will to participate in the study as indicated by the patient's signature.
- •Provision of written, informed consent prior to any study specific procedures.
- •Males and females ≥ 18 years of age.
- •Diagnosis of severe asthma, as defined by ATS/ERS guidelines (requiring high-dose ICS plus second controller and/or OCS, or uncontrolled despite this therapy).
- •Eligible for initiation of biologic therapy for treatment of asthma or already on active treatment but not yet in a state of four-domain asthma remission.
- •Women of childbearing potential (after menarche) must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit. Examples of effective birth control include:
- •True sexual abstinence
- •A vasectomized sexual partner
- •Implanon®
- •Female sterilization by tubal occlusion
- •Effective intrauterine device (IUD)/levonogestrel intrauterine system (IUS)
- •Depo-Provera™ injections
- •Oral contraceptive
- •Evra Patch™
- •Nuvaring™
- •Women of childbearing potential (after menarche) must agree to use a highly effective form of birth control, as defined above, from enrollment, throughout the study duration.
排除标准
- •Primary respiratory diagnoses other than asthma (e.g., COPD, bronchiectasis) that would meaningfully affect study endpoints per discretion of clinical team.
- •Patients with incomplete medical records.
- •Patients who are already in a state of asthma remission.
- •Patients with contraindications to PFT, sputum induction, CT imaging.
- •Patients who are pregnant or breastfeeding.
- •Patients who are unable or unwilling to comply with study procedures.
- •For the optional MRI procedure only: Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist).
- •In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the optional MRI or CT, such as severe claustrophobia.
- •Other contraindications to MRI.
研究组 & 干预措施
Comprehensive Management (Intervention)
Participants randomized to the comprehensive management arm will receive asthma management according to routine clinical practice in addition to a comprehensive management strategy. Specialized biomarker results from these specialized assessments will be made available to the treating clinician and may be incorporated into clinical decision-making regarding asthma management.
干预措施: Comprehensive Biomarker-Guided Management Strategy (Other)
Standard of Care
Participants randomized to the standard of care arm will receive severe asthma management according to routine clinical practice. Specialized research biomarker assessments will be performed; however, these results will not be disclosed to the treating clinician and will not be used to guide clinical management. Treatment decisions will be based on routinely available clinical information and standard clinical practice.
干预措施: Standard of Care (Other)
结局指标
主要结局
Eligibility Rate
时间窗: During the study recruitment period
Percentage of individuals screened for the study who meet the study eligibility criteria. The eligibility rate will be calculated as the number of screened individuals who meet the eligibility criteria divided by the total number of individuals screened, multiplied by 100
Recruitment Rate
时间窗: During the study recruitment period
The recruitment rate will be calculated as the number of participants enrolled divided by the duration of the recruitment period.
Enrolment Rate
时间窗: During the study recruitment period
The enrolment rate will be calculated as the number of eligible individuals enrolled divided by the total number of eligible individuals approached for participation, multiplied by 100.
Retention Rate
时间窗: Baseline(randomization) through Month 12
The retention rate will be calculated as the number of participants who complete the Month 12 follow-up divided by the total number of randomized participants, multiplied by 100.
Four-Domain Asthma Remission Rate in the Standard-of-Care Group
时间窗: Baseline(randomization) through Month 12
Percentage of participants randomized to the standard-of-care (control) group who meet the protocol-defined criteria for 4-domain asthma remission at Month 12. The remission rate will be a corresponding confidence interval and will be used to inform sample size calculations for a future full-scale randomized controlled trial.
Predictive Performance of Specialized Biomarkers for Asthma Remission and Relapse
时间窗: Baseline to Month 12
To evaluate the association between baseline specialized clinical, physiologic, airway inflammatory, and imaging biomarkers and asthma outcomes, including sustained remission and relapse, over the 12-month follow-up period. The predictive performance of specialized biomarkers will be compared with that of conventionally available biomarkers.
次要结局
- Study Assessment Completion Rate(Baseline (randomization) through Month 12)
- Adherence to Study Procedures(Baseline (randomization) through Month 12)
- Participant Acceptability of the Comprehensive Management Strategy(Baseline (randomization) through Month 12)
- Clinician Acceptability of the Comprehensive Management Strategy(Baseline (randomization) through Month 12)
研究者
Hana Serajeddini
MD, FRCPC Respirologist, Assistant Professor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's