Skip to content

Clinical Research on the Treatment of Moderate Bronchial Asthma with Inhaled Inactivated-Mycobacterium Phlei

Clinical Research on the Treatment of Moderate Bronchial Asthma with Inhaled Inactivated-Mycobacterium Phlei

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001189
Enrollment
Unknown
Registered
2011-02-26
Start date
2012-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma

Interventions

group A:The patients in group A were treated with inhaled inactivated-mycobacterium phlei F.U.36 Injection 1.72ug/mL*2 that adding 3mL normal saline, once a day for 7 days. one month, 3 months, 6 mont
guoup B:The patients in B group were treated with salmeterol xinafoate and fluticasone propionate powder for inhalation 50/100ug, twice daily for sustainable use. They can inhale Ventol as need to rel

Sponsors

Department of Public Health of Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 14-17 years old outpatients had signed the informed consent and can follow up easily, non sexy limitation; 2. Patients diagnosed with bronchial asthma, bronchial provocation test postive, inhaled methacoline bronchial provocation test postive, (PD20-FEV1)=15%and FEV1 increase>=200ml; 3. Complied with 2008 GINA recommendations chronic light moderated standard; 4. not participated in other clinical research in last 3 months. 5. Chest X-ray, ECG: no obvious abnormality.

Exclusion criteria

Exclusion criteria: 1. Patients who be known or suspected severe allergy to any drug or lactose; 2. Women in prenancy, breathfeeding period or got prenancy during the research; 3. Patients who use Glucocorticoid, Ketotifen, Montelukast etc anti-inflammatory and anti-allergy drug within one month; 4. Smoking >=10 packs/year (1pack/year=one pack per day or 20x1year or the equivalent amount); 5. Patients who are taking ACEI /ßblockers drugs; 6. Who got significant pulmonary infection and required antibiotic therapy; 7. Patients who were knowned got any severe disease or abnormality (like: cardiovascauar pulmonary disease except asthma, liver kidney disease and Neuro-endocrine disease. etc), participated the research may post a risk to them or affect the results; 8. Mental state and capacity cant assert the observation; 9. Patients who got any respiratory infections and affected the asthma within one month; 10. Patients who participate in another research within one month or during this reseach period.

Design outcomes

Primary

MeasureTime frame
the amount and proportion of gammadelta T cells subsets(vgamma1+ cells, vgamma4+ cells) unique genet;the number of gammadelta T cells and it's subsets(vgamma1+ cells, vgamma4+ cells);PM PEF;ACT score;AM PEF;PD20-FEV1;FEV1;

Secondary

MeasureTime frame
IL-4, IL-5, IFN-gama;the gene expression of IL-4, IL-5, IFN-gama;

Countries

China

Contacts

Public ContactChaoqian Li
lichaoqian@yahoo.com.cn+86 13807887867

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026