Maintenance at Initial Treatment With Sequential Anti-Inflammation Reliever Therapy

NCT06568445 | Not Yet Recruiting Phase 4

• 1 other identifier: ZYan
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Evaluate the efficacy of 4 weeks of maintenance therapy with low-dose ICS/LABA versus as-needed low-dose ICS/LABA in newly diagnosed mild asthma patients. Assess the improvement in FEV1 from baseline over 4 weeks, and the impact on airway reversibility and inflammation levels. Identify the optimal patient population and treatment regimen for the medication.
2. 2.Based on a comprehensive evaluation of pulmonary function parameters (including large airway parameters: FEV1, FEV1/FVC; peak flow: PEF; small airway parameters: FEF25%, FEF50%, FEF75%, MMEF) and airway inflammation levels, explore biomarkers that can effectively predict the efficacy of maintenance therapy with low-dose ICS/LABA in newly diagnosed mild asthma patients.
3. 3.Compare 4 weeks of initial maintenance therapy with low-dose ICS/LABA followed by as-needed low-dose ICS/LABA therapy until 24 weeks. In the 24-week study, incorporate mobile lung function monitoring to dynamically assess large and small airway function parameters and clinical indicators. Explore the impact of early maintenance therapy with low-dose ICS/LABA followed by as-needed treatment on FEV1 improvement from baseline, acute exacerbation risk indicators, and airway inflammation, and develop a model to predict acute exacerbations.

Conditions

Bronchial Asthma

Keywords

asthma; budesonide-formoterol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Change from baseline in forced expiratory volume in the first second (FEV1) at Week 8, 12, 16, 20, 24

  Baseline and Week 8, 12, 16, 20, 24

• Change from baseline in Asthma control test (ACT) scrore

  Baseline and Week 4, 8, 12, 16, 20, 24

• Change from baseline in Asthma control questionnaire-5 (ACQ-5)

  Baseline and Week 4, 8, 12, 16, 20, 24

• Change from baseline in Fractional exhaled nitric oxide (FENO)

  Baseline and Week 4, 8, 12, 16, 20, 24

• Change from baseline in Eosinophil counts in peripheral blood

  Baseline and Week 4, 8, 12, 16, 20, 24

Other Outcomes (1)

• Adverse events

  Week 4, 8, 12, 16, 20, 24

Study Arms (2)

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).

Drug: Maintenance at initial treatment sequential as-needed therapy with inhaled budesonide-formoterol(Symbicort 160/4.5) ®）

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.

Drug: as-needed therapy with inhaled budesonide-formoterol (Symbicort 160/4.5) ®）

Interventions

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.

Also known as: maintenance at initial treatment sequential as-needed therapy group

maintenance at initial treatment sequential as-needed therapy group

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.

Also known as: As-needed therapy group

As-needed therapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants fully understand the purpose and methods of the study, voluntarily agree to participate, and sign an informed consent form before any study procedures begin.
• Adults (including males and non-pregnant, non-lactating females) aged 18 to 70 years (inclusive), who are newly diagnosed with mild and non-acute bronchial asthma according to the latest Chinese guidelines for the prevention and treatment of bronchial asthma.
• During the screening period, participants must meet at least one of the following criteria for reversible airflow obstruction: Positive bronchodilator test (increase in FEV1 ≥12% and an absolute increase in FEV1 ≥200 mL after inhaling a bronchodilator). Positive bronchial provocation test (FEV1 decreases by ≥20% after inhalation of the provocation agent methacholine).
• At screening and the Day -1 visit before the induction period, participants must have a lung function test showing FEV1 ≥ 80% of the predicted value.
• Participants or their guardians must be able to communicate effectively with the researchers, understand, and comply with all requirements of the study.

You may not qualify if:

• Individuals allergic or intolerant to budesonide, formoterol, albuterol, or any component of the medication.
• Respiratory, sinus, or middle ear infections within the 2 months prior to screening or up to randomization that led to a change in asthma treatment, or are expected to alter the participant's asthma status according to the investigator's judgment.
• History of chronic obstructive pulmonary disease (COPD), interstitial lung disease, restrictive lung disease, tuberculosis, cystic fibrosis, bronchiectasis, or alpha-1 antitrypsin deficiency at screening.
• History of major diseases at screening, such as congestive heart failure, uncontrolled hypertension, severe coronary artery disease, myocardial infarction, or severe arrhythmias, or severe hematological, hepatic, neurological, musculoskeletal, endocrine, metabolic, psychiatric, renal, or other significant conditions. If any of these conditions worsen during the study, it may endanger the participant or affect study results.
• Excessive use of short-acting beta-agonists (SABA), defined as more than 8 inhalations per day, during the screening period and the run-in period.
• Use of beta-blockers (including eye drops), oral corticosteroids, systemic steroid treatments, investigational drugs, or leukotriene receptor antagonists (such as zafirlukast, pranlukast, montelukast, etc.) during the run-in period.
• History of smoking with a smoking index \>10 pack-years.
• Smoking cessation ≤6 months before the screening visit (Visit 1) or current smokers.
• Known or suspected alcohol and/or drug abuse, including heavy drinking (average daily consumption \>2 units of alcohol, where 1 unit = 360 mL of beer, 45 mL of 40% alcohol, or 150 mL of wine).
• Pregnant or breastfeeding females.
• Use of medications that may interact with the study drug within 1 month before screening, such as CYP3A4 inhibitors (e.g., ketoconazole, itraconazole), cimetidine, disulfiram, metronidazole, or CYP3A4 enzyme inducers (e.g., rifampin, carbamazepine, phenytoin).
• Participation in other medical device clinical trials within 1 month before screening or other drug clinical trials within 3 months before screening.
• Asthma total symptom score (daytime + nighttime) \<2 points in the week prior to randomization.
• Patients who cannot comply with the study procedures or who, in the investigator's judgment, are not suitable for participation in the study.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

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Related Links

• Related Info

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Yan Zhou

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Zhou

CONTACT

+8618964705743; zhouyan790304@163.com

Min Zhang

CONTACT

+8613482345145; maggie_zhangmin@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 23, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)