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| Name | Class |
|---|---|
| Capital Medical University | OTHER |
| Peking University Third Hospital | OTHER |
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Severe or uncontrolled asthma is a complex heterogeneous disease, in which patients may exhibit different types of airway inflammation and often accompany multiple comorbidities and risk factors. Identifying potential modifiable factors that influence prognosis, i.e., "treatable traits," and targeting these traits for individualized, bundled management of patients may help improve the quality of life of asthma patients and enhance asthma control levels. This project aims to investigate the distribution of treatable traits in uncontrolled asthma patients in Beijing by conducting pulmonary function tests, exhaled nitric oxide tests, blood tests, allergen IgE tests, and chest CT scans, as well as detailed questionnaires, on patients from three tertiary hospitals in Beijing. The project will also assess the impact of treatable traits on the quality of life or asthma control levels of uncontrolled asthma patients in a multidimensional manner. Furthermore, the project will select severe asthma patients and establish an individualized, bundled management model based on the treatable traits of severe asthma, through multidisciplinary consultations and shared decision-making with patients. A randomized, parallel-group clinical trial will then be conducted for six months to confirm whether this management model is superior to conventional management in improving the quality of life or asthma control levels of severe asthma patients. The implementation of this project will establish a new model of individualized management for severe asthma based on treatable traits, thereby improving the management level of severe asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Implement individualized cluster management based on treatable traits |
|
| Placebo | Other | Routine asthma treatment according to current guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized cluster management | Procedure | Individualized cluster management for treatable traits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Quality of life score (AQLQ) | Changes in asthma Quality of life score (AQLQ) from baseline at 6 months;Asthma Quality of Life questionnaire (AQLQ) is a scoring scale to evaluate the quality of life of patients with asthma, evaluating the level of asthma control in the past 2 weeks. The AQLQ consisted of 32 questions, which were divided into four sub-areas: symptoms (12 questions), activity limitation (11 questions), emotional function (5 questions) and environmental stimulation (4 questions). Each question was scored on a scale of 1 to 7 points according to its severity, with 1 indicating complete limitation and 7 indicating no limitation at all. The total score is calculated as the average of all questions and the average of each partition. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Questionnaire score (ACQ-5) | Changes in Asthma Control Questionnaire score (ACQ-5) from baseline at 6 months;ACQ-5 (Asthma Control Questionnaire) is a scoring scale for assessing asthma control. It consists of 5 simple questions to assess a patient's level of asthma control in the past week. Each problem was scored on a scale of 0-6 according to its severity. The average score of the five problems <0.75 was asthma control, 0.75 ~ 1.5 was asthma partial control, and >1.5 was asthma uncontrolled. |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University | Beijing | Beijing Municipality | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29326330 | Result | Rose L, Istanboulian L, Carriere L, Thomas A, Lee HB, Rezaie S, Shafai R, Fraser I. Program of Integrated Care for Patients with Chronic Obstructive Pulmonary Disease and Multiple Comorbidities (PIC COPD+): a randomised controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701567. doi: 10.1183/13993003.01567-2017. Print 2018 Jan. | |
| 27471050 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Routine asthma treatment | Procedure | Routine asthma treatment according to current guidelines |
|
| 6 months |
| Forced Expiratory Volume in 1 second(FEV1) | Changes in lung function Forced Expiratory Volume in 1 second(FEV1) from baseline | 6 months |
| Exacerbation | the number of acute asthma attacks within 6 months | 6 months |
| Peking University Third Hospital | Beijing | Haidian | 100191 | China |
| Beijing Luhe Hospital affiliated to Capital Medical University | Beijing | Tongzhou | 101199 | China |
| Ko FW, Cheung NK, Rainer TH, Lum C, Wong I, Hui DS. Comprehensive care programme for patients with chronic obstructive pulmonary disease: a randomised controlled trial. Thorax. 2017 Feb;72(2):122-128. doi: 10.1136/thoraxjnl-2016-208396. Epub 2016 Jul 28. |
| 30846468 | Result | McDonald VM, Fingleton J, Agusti A, Hiles SA, Clark VL, Holland AE, Marks GB, Bardin PP, Beasley R, Pavord ID, Wark PAB, Gibson PG; participants of the Treatable Traits Down Under International Workshop; Treatable Traits Down Under International Workshop participants:. Treatable traits: a new paradigm for 21st century management of chronic airway diseases: Treatable Traits Down Under International Workshop report. Eur Respir J. 2019 May 9;53(5):1802058. doi: 10.1183/13993003.02058-2018. Print 2019 May. |
| 33831621 | Result | Wu WW, Zhang X, Li M, Liu Y, Chen ZH, Xie M, Zhao SZ, Wang G, Zhang HP, Wang T, Qin L, Wang L, Oliver BG, Wan HJ, Zhang J, McDonald VM, Marks GB, Li WM, Birring SS, Wang G, Gibson PG. Treatable Traits in Elderly Asthmatics from the Australasian Severe Asthma Network: A Prospective Cohort Study. J Allergy Clin Immunol Pract. 2021 Jul;9(7):2770-2782. doi: 10.1016/j.jaip.2021.03.042. Epub 2021 Apr 5. |
| 30230137 | Result | McDonald VM, Hiles SA, Godbout K, Harvey ES, Marks GB, Hew M, Peters M, Bardin PG, Reynolds PN, Upham JW, Baraket M, Bhikoo Z, Bowden J, Brockway B, Chung LP, Cochrane B, Foxley G, Garrett J, Jayaram L, Jenkins C, Katelaris C, Katsoulotos G, Koh MS, Kritikos V, Lambert M, Langton D, Lara Rivero A, Middleton PG, Nanguzgambo A, Radhakrishna N, Reddel H, Rimmer J, Southcott AM, Sutherland M, Thien F, Wark PAB, Yang IA, Yap E, Gibson PG. Treatable traits can be identified in a severe asthma registry and predict future exacerbations. Respirology. 2019 Jan;24(1):37-47. doi: 10.1111/resp.13389. Epub 2018 Sep 19. |
| 31806719 | Result | McDonald VM, Clark VL, Cordova-Rivera L, Wark PAB, Baines KJ, Gibson PG. Targeting treatable traits in severe asthma: a randomised controlled trial. Eur Respir J. 2020 Mar 5;55(3):1901509. doi: 10.1183/13993003.01509-2019. Print 2020 Mar. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |