Multicenter clinical study on light moderate asthma by aerosol inhalation of Mycobacterium Phlei

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10000765

Enrollment

Unknown

Registered

2010-01-15

Start date

2009-05-01

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:Utilin 1.72UgX2+Saline 3ml, inhalation, once a day, 5 days/a course of treament.6days, one month, 3 months, 6 months,1 year after treament review the indicator respectively, and carry one inte

Group B:Seretide 50/100µg, do falling-rising ladder adjust

Group C:As a negative control of group A apply saline 5ml,inhalation, once perday, 5 days/a course of treatment. At the beginning of 1-3days inform the patients inhaled Ventolin twice per day with 2 s

if overcome effective resullts, do the same way of group A, program the intensive ther

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. Comply with 2008 GINA recommendations chronic light moderated standard; 4. not participated in other clinical research in last 3 months; 5. Chest X-ray: 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 /beta blockers drugs; 6. Who got significant pulmonary infection and required antibiotic therapy; 7. Patients who be 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. Someone who got any respiratory infections and affected the asthma within one month; 10. Someone who participate in another research within one month or during this reseach period.

Design outcomes

Primary

Measure	Time frame
PD20-FEV;	—

Secondary

Measure	Time frame
ACT score;FEV1;AM PEF;PM PEF;	—

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