Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a 1:1 ratio to research group (maintenance at initial treatment sequential as-needed therapy group) and control group (As-needed therapy group).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| maintenance at initial treatment sequential as-needed therapy group | Experimental | budesonide 160 µg-formoterol 4.5 µg (Symbicort 160/4.5) ®), administered as one inhalation twice daily for maintenance for 4 weeks, sequential as-needed therapy for symptom relief to 24-week (no more than 8 inhalations per day). |
|
| As-needed therapy group | Active Comparator | Inhaled budesonide-formoterol as needed when symptoms are present (Symbicort 160/4.5) ®),no more than 8 inhalations per day, continuous to 24-week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maintenance at initial treatment sequential as-needed therapy with inhaled budesonide-formoterol(Symbicort 160/4.5) ®) | Drug | one inhalation twice daily for 4 weeks maintenance, sequential as-needed for symptom relief (no more than 8 inhalations per day) to 24-week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in forced expiratory volume in the first second (FEV1) at week 4 | Spirometry was performed at baseline and after 4-week treatment, between 8:00 am and 10:30 am using MS-PFT spirometer (Jaeger, Hoechberg, Germany). Spirometry tests followed the standards of American Thoracic Society (ATS)/European Respiratory Society (ERS) recommendations. FEV1 is one pulmonary function parameter. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in forced expiratory volume in the first second (FEV1) at Week 8, 12, 16, 20, 24 | Spirometry was performed at baseline and after 8, 12,16, 20,24-week treatment, between 8:00 am and 10:30 am using MS-PFT spirometer (Jaeger, Hoechberg, Germany). Spirometry tests followed the standards of American Thoracic Society (ATS)/European Respiratory Society (ERS) recommendations. FEV1 is one pulmonary function parameter. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Summarize the frequency, number, and incidence of the following adverse events by formulation group, severity, system organ classification (SOC), and preferred term for adverse events (PT): TEAE, TEAE related to the investigational drug. The incidence rate of adverse events shall be calculated at least once per subject for each SOC and PT. | Week 4, 8, 12, 16, 20, 24 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Zhou | Contact | +8618964705743 | zhouyan790304@163.com | |
| Min Zhang | Contact | +8613482345145 | maggie_zhangmin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Zhou | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31230828 | Background | Huang K, Yang T, Xu J, Yang L, Zhao J, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Chen Y, Sun T, Shan G, Lin Y, Xu G, Wu S, Wang C, Wang R, Shi Z, Xu Y, Ye X, Song Y, Wang Q, Zhou Y, Li W, Ding L, Wan C, Yao W, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Wang Z, Chen Z, Bu X, Zhang H, Zhang X, An L, Zhang S, Zhu J, Cao Z, Zhan Q, Yang Y, Liang L, Tong X, Dai H, Cao B, Wu T, Chung KF, He J, Wang C; China Pulmonary Health (CPH) Study Group. Prevalence, risk factors, and management of asthma in China: a national cross-sectional study. Lancet. 2019 Aug 3;394(10196):407-418. doi: 10.1016/S0140-6736(19)31147-X. Epub 2019 Jun 20. | |
| 17508962 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Sharing research plans, publishing data papers, and applying for patents
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| as-needed therapy with inhaled budesonide-formoterol (Symbicort 160/4.5) ®) | Drug | as-needed for symptom relief (no more than 8 inhalations per day) to 24-week. |
|
|
| Baseline and Week 8, 12, 16, 20, 24 |
| Change from baseline in Asthma control test (ACT) scrore | The ACT consists of 5 questions, each with a score ranging from 1 to 5 (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). The ACT score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. ACT score ≥20 indicates well-controlled asthma. | Baseline and Week 4, 8, 12, 16, 20, 24 |
| Change from baseline in Asthma control questionnaire-5 (ACQ-5) | The ACQ-5 score was calculated as the mean score of 5 questions about asthma symptoms during the previous week. Each question is scored from 0 (no impairment) to 6 (maximum impairment), with higher scores reflecting poorer asthma control. ACQ-5 score >1.5 (asthma is poorly controlled), ACQ-5 score 0.75 -1.5 (asthma is partially controlled), ACQ-5 score <0.75 (asthma is well controlled). | Baseline and Week 4, 8, 12, 16, 20, 24 |
| Change from baseline in Fractional exhaled nitric oxide (FENO) | FENO was measured using NIOX MINO (Aerocrine AB, Solna, Sweden) at a standard flow rate of 50 ml/s following the ATS/ERS recommendations. FENO measurements were performed before spirometry and BCT since the involved breathing maneuvers may distort FENO results. | Baseline and Week 4, 8, 12, 16, 20, 24 |
| Change from baseline in Eosinophil counts in peripheral blood | Complete blood count (CBC) of peripheral blood was performed at baseline and after treatment by the clinical laboratory of Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. | Baseline and Week 4, 8, 12, 16, 20, 24 |
| Change from baseline in Induced sputum classification and counting | Induced sputum method refers to inducing sputum production by inhaling nebulized hypertonic saline solution, and further analyzing the cellular components and soluble mediators in the supernatant of the sputum | Baseline and Week 4, 8, 12, 16, 20, 24 |
| Acute exacerbation of bronchial asthma | Monitor the number of acute exacerbations of asthma, weeks of asthma symptom control, emergency medication, dosage of ICS and (oral corticosteroid) OCS, and use of background medication in patients after treatment. | Week 4, 8, 12, 16, 20, 24 |
| Change from baseline in Forced Expiratory Flow at between 25% and 75% (FEF25%-75%) | FEF25%-75% is one pulmonary function parameter measured in spirometry. | Baseline and Week 4, 8, 12, 16, 20, 24 |
| Background |
| Dusser D, Montani D, Chanez P, de Blic J, Delacourt C, Deschildre A, Devillier P, Didier A, Leroyer C, Marguet C, Martinat Y, Piquet J, Raherison C, Serrier P, Tillie-Leblond I, Tonnel AB, Tunon de Lara M, Humbert M. Mild asthma: an expert review on epidemiology, clinical characteristics and treatment recommendations. Allergy. 2007 Jun;62(6):591-604. doi: 10.1111/j.1398-9995.2007.01394.x. |
| 33270095 | Background | Cloutier MM, Dixon AE, Krishnan JA, Lemanske RF Jr, Pace W, Schatz M. Managing Asthma in Adolescents and Adults: 2020 Asthma Guideline Update From the National Asthma Education and Prevention Program. JAMA. 2020 Dec 8;324(22):2301-2317. doi: 10.1001/jama.2020.21974. |
| 18635346 | Background | Bergstrom SE, Boman G, Eriksson L, Formgren H, Foucard T, Horte LG, Janson C, Spetz-Nystrom U, Hedlin G. Asthma mortality among Swedish children and young adults, a 10-year study. Respir Med. 2008 Sep;102(9):1335-41. doi: 10.1016/j.rmed.2008.03.020. Epub 2008 Jul 17. |
| 33945639 | Background | Crossingham I, Turner S, Ramakrishnan S, Fries A, Gowell M, Yasmin F, Richardson R, Webb P, O'Boyle E, Hinks TS. Combination fixed-dose beta agonist and steroid inhaler as required for adults or children with mild asthma. Cochrane Database Syst Rev. 2021 May 4;5(5):CD013518. doi: 10.1002/14651858.CD013518.pub2. |
| 31112386 | Background | Beasley R, Holliday M, Reddel HK, Braithwaite I, Ebmeier S, Hancox RJ, Harrison T, Houghton C, Oldfield K, Papi A, Pavord ID, Williams M, Weatherall M; Novel START Study Team. Controlled Trial of Budesonide-Formoterol as Needed for Mild Asthma. N Engl J Med. 2019 May 23;380(21):2020-2030. doi: 10.1056/NEJMoa1901963. Epub 2019 May 19. |
| 31451207 | Background | Hardy J, Baggott C, Fingleton J, Reddel HK, Hancox RJ, Harwood M, Corin A, Sparks J, Hall D, Sabbagh D, Mane S, Vohlidkova A, Martindale J, Williams M, Shirtcliffe P, Holliday M, Weatherall M, Beasley R; PRACTICAL study team. Budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): a 52-week, open-label, multicentre, superiority, randomised controlled trial. Lancet. 2019 Sep 14;394(10202):919-928. doi: 10.1016/S0140-6736(19)31948-8. Epub 2019 Aug 23. |
| 18405951 | Background | Busse WW, Pedersen S, Pauwels RA, Tan WC, Chen YZ, Lamm CJ, O'Byrne PM; START Investigators Group. The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up: effectiveness of early intervention with budesonide in mild persistent asthma. J Allergy Clin Immunol. 2008 May;121(5):1167-74. doi: 10.1016/j.jaci.2008.02.029. Epub 2008 Apr 11. |
| 7587421 | Background | Selroos O, Pietinalho A, Lofroos AB, Riska H. Effect of early vs late intervention with inhaled corticosteroids in asthma. Chest. 1995 Nov;108(5):1228-34. doi: 10.1378/chest.108.5.1228. |
| 18387797 | Background | Selroos O. Effect of disease duration on dose-response of inhaled budesonide in asthma. Respir Med. 2008 Jul;102(7):1065-72. doi: 10.1016/j.rmed.2007.12.029. Epub 2008 Apr 2. |
| 18990678 | Background | O'Byrne PM, Pedersen S, Lamm CJ, Tan WC, Busse WW; START Investigators Group. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009 Jan 1;179(1):19-24. doi: 10.1164/rccm.200807-1126OC. Epub 2008 Oct 31. |
| 31593318 | Background | Henneberger PK, Patel JR, de Groene GJ, Beach J, Tarlo SM, Pal TM, Curti S. Workplace interventions for treatment of occupational asthma. Cochrane Database Syst Rev. 2019 Oct 8;10(10):CD006308. doi: 10.1002/14651858.CD006308.pub4. |
| 17507703 | Background | Papi A, Canonica GW, Maestrelli P, Paggiaro P, Olivieri D, Pozzi E, Crimi N, Vignola AM, Morelli P, Nicolini G, Fabbri LM; BEST Study Group. Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma. N Engl J Med. 2007 May 17;356(20):2040-52. doi: 10.1056/NEJMoa063861. |
| 21324520 | Background | Martinez FD, Chinchilli VM, Morgan WJ, Boehmer SJ, Lemanske RF Jr, Mauger DT, Strunk RC, Szefler SJ, Zeiger RS, Bacharier LB, Bade E, Covar RA, Friedman NJ, Guilbert TW, Heidarian-Raissy H, Kelly HW, Malka-Rais J, Mellon MH, Sorkness CA, Taussig L. Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma (TREXA): a randomised, double-blind, placebo-controlled trial. Lancet. 2011 Feb 19;377(9766):650-7. doi: 10.1016/S0140-6736(10)62145-9. Epub 2011 Feb 14. |
| 22968888 | Background | Calhoun WJ, Ameredes BT, King TS, Icitovic N, Bleecker ER, Castro M, Cherniack RM, Chinchilli VM, Craig T, Denlinger L, DiMango EA, Engle LL, Fahy JV, Grant JA, Israel E, Jarjour N, Kazani SD, Kraft M, Kunselman SJ, Lazarus SC, Lemanske RF, Lugogo N, Martin RJ, Meyers DA, Moore WC, Pascual R, Peters SP, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Wasserman SI, Walter MJ, Wechsler ME, Boushey HA; Asthma Clinical Research Network of the National Heart, Lung, and Blood Institute. Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: the BASALT randomized controlled trial. JAMA. 2012 Sep 12;308(10):987-97. doi: 10.1001/2012.jama.10893. |
| 31371165 | Background | Sumino K, Bacharier LB, Taylor J, Chadwick-Mansker K, Curtis V, Nash A, Jackson-Triggs S, Moen J, Schechtman KB, Garbutt J, Castro M. A Pragmatic Trial of Symptom-Based Inhaled Corticosteroid Use in African-American Children with Mild Asthma. J Allergy Clin Immunol Pract. 2020 Jan;8(1):176-185.e2. doi: 10.1016/j.jaip.2019.06.030. Epub 2019 Jul 30. |
| Aug 19, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2024 | Aug 19, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided