2024-513195-18-00招募中3 期
REVERT : REVErsing airway Remodelling with Tezepelumab : a protocol for a double blind randomized controlled trial for patients with asthma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- Comparaison on CT-scan in the change in mean percentage bronchial wall area (%WA) at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 6 months
研究概览
简要总结
To compare the change-from-baseline in the average percentage bronchial wall area (%WA = (wall area (mm2)/ (wall area (mm2) + lumen area (mm2)))×100) on CT scan for patients with asthma and undergoing 6 months of tezepelumab treatment with a similar population treated via placebo
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Minimum age: 18
- •Based on results of screening visit and run-in: Oral corticosteroid maintenance therapy (if used) is 7.5 mg/day
- •Based on results of screening visit and run-in: On CT scan, the average percentage wall area index at the B1 and B8 bronchi (generation 3, 4, 5) is >65%
- •Maximum age: 85
- •Able to perform an inspiratory and expiratory thoracic computed tomography (CT) scan, plus a nasal CT
- •In stable condition for CT scan
- •Physician-diagnosed asthma according to GINA criteria
- •Disease with clinical impact: at least 1 severe or 2 moderate exacerbations in the previous 12 months despite treatment according to the best standards of care
- •Maximal inhaled therapy comprising high dose ICS and at least a second controller according to GINA
- •Based on results of screening visit and run-in: Post-bronchodilator forced expiratory volume in 1 second (FEV1) predicted values must be at 25-90%
- •Based on results of screening visit and run-in: Asthma Control Questionnaire 6 (ACQ6) > 1.5
排除标准
- •CT abnormalities evocative of any respiratory condition other than asthma
- •Potential interference from other studies
- •Protected populations according to the French public health code
- •Male or female patients seeking to conceive a child
- •Women of childbearing potential and fertile men not using birth control method
- •Pregnant, breastfeeding or lactating women
- •History of a clinically significant infection, including upper (URTI) or lower respiratory tract infection (LRTI), requiring treatment with antibiotics or antiviral medications finalised < 2 weeks before randomization. Patients with pre-existing serious infections should be treated before initiating therapy with tezepelumab
- •A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy
- •Patients using vaping products, including electronic cigarettes (because may induce abnormality at CT scan)
- •Bronchial thermoplasty in the last 12 months prior to Visit 1
- •History of documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy
- •Treatment regimen discordant with best practices
- •History of known immunodeficiency disorder including a positive human immunodeficiency virus test or the participant taking antiretroviral medications as determined by medical history and/or participant’s verbal report
- •Receipt of the T2 cytokine inhibitor Suplatast tosilate within 15 days prior to randomization
- •Treatment with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate, cyclosporine, etc.), except for OCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to randomization
- •Receipt of immunoglobulin or blood products within 30 days prior to randomization
- •Receipt of allergen immunotherapy not stable within 30 days prior to randomization or with anticipated change during the treatment period
- •Pulmonary disease other than asthma‡ requiring treatment during the previous 12 months
- •A smoking history of >20 pack years
- •Receipt of any marketed or investigational biologic agent within 3 months or 5 half-lives (whichever is longer) prior to randomization or receipt of any investigational non biologic agent within 30 days or 5 half-lives (whichever is longest) prior to randomization or receipt of live attenuated vaccines 30 days prior to the date of randomization. Participants enrolled in current or previous tezepelumab studies will not be included. Participants on previous biologics treatment are allowed to enter the study provided the appropriate washout period is fulfilled.
- •Absence of signed consent
- •Non-beneficiary of the French social security, single-payer health insurance system
- •Presence of any condition (physical, psychological or other) that might, in the investigator’s opinion, hinder study performance
- •The patient is unavailable or unwilling to participate in future visits
结局指标
主要结局
Comparaison on CT-scan in the change in mean percentage bronchial wall area (%WA) at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 6 months
Comparaison on CT-scan in the change in mean percentage bronchial wall area (%WA) at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 6 months
次要结局
- Change in Total small Airway Count (TAC) between Baseline and 6 months
- Comparaison on CT-scan the change in mean %WA between arms between baseline and 12 months
- Comparaison on CT-scan in the average percentage bronchia wall thickness index (%WT) at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 6 months
- Comparaison on CT-scan in the average percentage bronchia wall thickness index (%WT) at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 12 months
- Comparaison on CT-scan the change in wall area at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 6 months
- Change in total lung capacity between Baseline and 6 months
- Comparaison on CT-scan the change in lumen area at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 6 months
- Comparaison on CT-scan the change in ratio wall area (WA) / lumen area(LM) at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 6 months
- Comparaison on CT-scan the change in lumen diameter at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 6 months
- Comparaison on CT-scan the change in lumen circularity at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 6 months
- Comparaison on CT-scan in the average percentage bronchial wall area(%WA) corrected by body surface area(BSA) at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 6 months
- Comparaison on CT-scan in the average percentage bronchial wall thickness (%WT) corrected by body surface area (BSA) at the B1 and B8 bronchi, generations 3, 4 and 5 between baseline and 6 months
- Change in the expiratory to inspiration ratio of mean lung density (MLDe/i) at Baseline, 6 months and 12 months
- Quantitative computed tomography measurements to evaluate airflow obstruction at Baseline, 6 months and 12 months
- Change in Total small Airway Count (TAC) between Baseline and 12 months
- Change in Lund Mackay score between Baseline and 6 months
- Change in Lund Mackay score between Baseline and 12 months
- Change in Presence/absence of nasal polyposis between Baseline and 6 months
- Change in Presence/absence of nasal polyposis between Baseline and 12 months
- Change in Annualized exacerbation rates between Baseline and 12 months
- Change in Days alive and not exacerbating between Baseline and 12 months
- Change in Days alive and not hospitalized between Baseline and 12 months
- Change in forced expiratory volume in 1 second between Baseline and 6 months
- Change in forced expiratory volume in 1 second between Baseline and 12 months
- Change in forced vital capacity between Baseline and 6 months
- Change in forced vital capacity between Baseline and 12 months
- Change in forced expiratory volume in 1 second / forced vital capacity Ratio between Baseline and 6 months
- Change in forced expiratory volume in 1 second / forced vital capacity Ratio between Baseline and 12 months
- Change in total lung capacity between Baseline and 12 months
- Change in residual volume between Baseline and 6 months
- Change in residual volume between Baseline and 12 months
- Change in total lung capacity (TLC)/ residual volume(RV) ratio between Baseline and 6 months
- Change in total lung capacity (TLC)/ residual volume(RV) ratio between Baseline and 12 months
- Change in mean ACQ (Asthma Control Questionnaire)-6 score between Baseline and 6 months
- Change in mean ACQ (Asthma Control Questionnaire)-6 score between Baseline and 12 months
- Change in Breathlessness, Cough and Sputum Scale (BCSS) between Baseline and 6 months
- Change in Breathlessness, Cough and Sputum Scale (BCSS) between Baseline and 12 months
- Change in Sino Nasal Outcome Test 22 between Baseline and 6 months
- Change in Sino Nasal Outcome Test 22 between Baseline and 12 months
- Change in St George Respiratory Questionnaire (SGRQ) between Baseline and 6 months
- Change in St George Respiratory Questionnaire (SGRQ) between Baseline and 12 months
- Change in ECRHS III Main Questionnaire between Baseline and 6 months
- Change in ECRHS III Main Questionnaire between Baseline and 12 months
- Changes in serum Club cell secretory protein (CCSP) between baseline and 6 months
- Changes in serum Club cell secretory protein (CCSP) between baseline and 12 months
- Number of adverse event between arms between baseline and 6 months
研究者
Arnaud BOURDIN
Scientific
Centre Hospitalier Universitaire De Montpellier
研究点 (11)
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