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Bronchial AsthmaPhase 4MIT-AIRNCT06568445

Maintenance at Initial Treatment With Sequential Anti-Inflammation Reliever Therapy

A Phase 4 study testing 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 people with Bronchial Asthma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Bronchial Asthma
What is being tested?
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) ®）
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
12 Aug 2024to 30 Sep 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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).
  • Abnormal and clinically significant results in vital signs, physical examination, 12-lead ECG, chest CT, blood tests, urinalysis, blood biochemistry, or coagulation tests at screening and the Day -1 visit, unless judged by the investigator to be related to the study condition and not affecting inclusion.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yan Zhou contact

+8618964705743

zhouyan790304@163.com

Min Zhang contact

+8613482345145

maggie_zhangmin@163.com

China1 site

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

    Xueying Ding

Other trials in China

About this study

Official title: Efficacy of Regular ICS/LABA Sequential As-Needed Therapy in Newly Diagnosed Mild Asthma Patients: A Randomized, Parallel, Positive-Control Study

  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. 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. 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.
Read the detailed description

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).

Being tested
Maintenance at initial treatment sequential as-needed therapy with inhaled budesonide-formoterol(Symbicort 160/4.5) ®）, as-needed therapy with inhaled budesonide-formoterol (Symbicort 160/4.5) ®）
Keywords
asthma, budesonide-formoterol
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called maintenance at initial treatment sequential as-needed therapy group

    one inhalation twice daily for 4 weeks maintenance, sequential as-needed for symptom relief (no more than 8 inhalations per day) to 24-week.

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

    Also called As-needed therapy group

    as-needed for symptom relief (no more than 8 inhalations per day) to 24-week.

Study groups in NCT06568445
Study groupRoleWhat they receive
maintenance at initial treatment sequential as-needed therapy groupExperimentalbudesonide 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).
Receives: Drug: Maintenance at initial treatment sequential as-needed therapy with inhaled budesonide-formoterol(Symbicort 160/4.5) ®）
As-needed therapy groupActive comparatorInhaled budesonide-formoterol as needed when symptoms are present (Symbicort 160/4.5) ®），no more than 8 inhalations per day, continuous to 24-week.
Receives: Drug: as-needed therapy with inhaled budesonide-formoterol (Symbicort 160/4.5) ®）

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 4

Secondary outcomes (8)

  1. 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.

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

  2. 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.

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

  3. 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).

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

  4. 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.

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

  5. 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.

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

  6. 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

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

  7. 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.

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

  8. Change from baseline in Forced Expiratory Flow at between 25% and 75% (FEF25%-75%)

    FEF25%-75% is one pulmonary function parameter measured in spirometry.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2024
  2. Study start12 Aug 2024 (estimated)
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06568445
Sponsor's protocol ID
ZYan
Acronym
MIT-AIR
Status last verified
Aug 2024
First submitted
19 Aug 2024
Last updated
23 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sharing research plans, publishing data papers, and applying for patents

Publications

  • 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.

    PubMed 31230828

  • 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.

    PubMed 17508962

  • 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.

    PubMed 33270095

  • 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.

    PubMed 18635346

  • 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.

    PubMed 33945639

  • 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.

    PubMed 31112386

  • 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.

    PubMed 31451207

  • 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.

    PubMed 18405951

  • 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.

    PubMed 7587421

  • 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.

    PubMed 18387797

  • 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.

    PubMed 18990678

  • 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.

    PubMed 31593318

  • 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.

    PubMed 17507703

  • 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.

    PubMed 21324520

  • 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.

    PubMed 22968888

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 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 people with Bronchial Asthma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yan Zhou (+8618964705743, zhouyan790304@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in forced expiratory volume in the first second (FEV1) at week 4 (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06568445, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.

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