A Phase 4 interventional study of Maintenance at initial treatment sequential as-needed therapy with inhaled budesonide-formoterol(Symbicort 160/4.5) ®） and as-needed therapy with inhaled budesonide-formoterol (Symbicort 160/4.5) ®） in Bronchial Asthma, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment
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).
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's planned enrollment of 90 is close to the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 182 studies on the registry; 108 are open to participants now.
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Exclusion Criteria:
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).
Drug: Maintenance at initial treatment sequential as-needed therapy with inhaled budesonide-formoterol(Symbicort 160/4.5) ®）
Inhaled budesonide-formoterol as needed when symptoms are present (Symbicort 160/4.5) ®），no more than 8 inhalations per day, continuous to 24-week.
Drug: as-needed therapy with inhaled budesonide-formoterol (Symbicort 160/4.5) ®）
one inhalation twice daily for 4 weeks maintenance, sequential as-needed for symptom relief (no more than 8 inhalations per day) to 24-week.
Also known as: maintenance at initial treatment sequential as-needed therapy group
as-needed for symptom relief (no more than 8 inhalations per day) to 24-week.
Also known as: As-needed therapy group
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.
Time frame: Baseline and Week 4
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 4, 8, 12, 16, 20, 24
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.
Time frame: Week 4, 8, 12, 16, 20, 24
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Sharing research plans, publishing data papers, and applying for patents
Start is estimated for Aug 2024; primary completion for Apr 2027, 31 months later.
Of 76 non-industry phase 4 interventional studies under Asthma, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 31 months is above that.
Counting every sponsor, half of 135 studies reached it within 22 months; a quarter within 11 and three quarters within 36.
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This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine →